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Updates and Additions for the Database 10/18/16

Submitted by Biotech Team on Tue, 10/18/2016 - 08:23.

Today's updates and additions to the Biotechnology Events database can be found at the top. We will be making updates available throughout the day. Past entries are listed below.

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Updates for October 18, 2016

1) The Medicines Company, Inc. - The Medicines Company Announces Positive Top-Line Results from Day 90 Interim Analysis in Ongoing ORION-1 Phase 2 Study of PCSK9si
http://www.biotechnologyevents.com/node/11252

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Updates for October 05, 2016

1) pSivida Corporation - Phase 3 trial of Medidur™ in Posterior Segment Uveitis Meets Enrollment Target - Study is the Second of Two Ongoing Phase 3 Trials in Support Of Product Registration in the US
http://www.biotechnologyevents.com/node/6094

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Updates for September 19, 2016

1)Sarepta Therapeutics, Inc. - Sarepta Therapeutics Announces FDA Accelerated Approval of EXONDYS 51™ (eteplirsen) injection, an Exon Skipping Therapy to Treat Duchenne Muscular Dystrophy (DMD) Patients Amenable to Skipping Exon 51 - EXONDYS 51™ the first DMD treatment approved in the US, targets dystrophin deficiency, the underlying cause of Duchenne - U.S. Commercial Launch planned to commence immediately -
http://www.biotechnologyevents.com/node/8625

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Updates for September 14, 2016

1) Spectrum Pharmaceuticals, Inc. - FDA Advisory Committee Votes that Qapzola™ (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo - The FDA is Expected to Make a Final Decision by PDUFA Date of December 11, 2016 -
http://www.biotechnologyevents.com/node/7115

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Updates for September 12, 2016

1) Raptor Pharmaceutical Corp. - Horizon Pharma plc to Acquire Raptor Pharmaceutical Corp. as Further Step in Building Leading Rare Disease Business - Transaction valued at $9.00 per share in cash with fully diluted equity value of approximately $800 million -
http://www.biotechnologyevents.com/node/12104

2) Repros Therapeutics Inc. - Repros Announces Submission of MAA to the European Medicines Agency for Enclomiphene in the Treatment of Secondary Hypogonadism - UK designated as rapporteur and France as co-rapporteur Average time to approval 13 - 16 months
http://www.biotechnologyevents.com/node/12105

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Updates for September 6, 2016

1) Exelixis, Inc. - Exelixis Announces Outcome from First Planned Interim Analysis of the Phase 3 CELESTIAL Trial of Cabozantinib in Patients with Advanced Hepatocellular Carcinoma
http://www.biotechnologyevents.com/node/8514

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Updates for August 30, 2016

1) Rigel Pharmaceuticals, Inc. - Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP
http://www.biotechnologyevents.com/node/10121

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Updates for August 29, 2016

1) CTI Biopharma Corp. - CTI BioPharma Announces Top-Line Results From PERSIST-2 Phase 3 Trial Of Pacritinib For High-Risk Patients With Advanced Myelofibrosis - Trial demonstrates statistically significant improvement in spleen volume reduction (SVR) with pacritinib compared to best available therapy (BAT), including ruxolitinib -
http://www.biotechnologyevents.com/node/8463

2) Neurocrine Biosciences, Inc. - Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia
http://www.biotechnologyevents.com/node/11199

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Updates for August 23, 2016

1) Clovis Oncology, Inc. - FDA ACCEPTS CLOVIS ONCOLOGY’S NEW DRUG APPLICATION FOR RUCAPARIB FOR PRIORITY REVIEW FOR THE TREATMENT OF ADVANCED MUTANT BRCA OVARIAN CANCER - Seeking approval for mutant BRCA patients treated with two or more prior therapies - FDA Grants Priority Review Status - Assigns PDUFA Date of February 23, 2017
http://www.biotechnologyevents.com/node/11337

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Updates for August 16, 2016

1) OncoGenex Pharmaceuticals, Inc. - OncoGenex Announces Results from the Phase 3 AFFINITY Trial of Custirsen in Men with Metastatic Castrate-Resistant Prostate Cancer

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Updates for August 15, 2016

1) Celsion Corporation - Celsion Corporation Announces Final Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer - Subgroup Data Continue to Show a Statistically Significant Improvement in Overall Survival, Consistent With a Two Year Median Survival Benefit Following Treatment with ThermoDox® plus Optimized RFA - Data from the Chinese Cohort of Patients Show Clinically Meaningful Benefit
http://www.biotechnologyevents.com/node/7065

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Updates for August 5, 2016

1) Dynavax Technologies Corporation - Dynavax Announces FDA Advisory Committee Meeting to Review HEPLISAV-B - Advisory Committee Meeting Scheduled for November 16, 2016
http://www.biotechnologyevents.com/node/11904

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Updates for August 2, 2016

1) Biogen Idec, Inc./Ionis Pharmaceuticals, Inc. - Biogen and Ionis Pharmaceuticals Report Nusinersen Meets Primary Endpoint at Interim Analysis of Phase 3 ENDEAR Study in Infantile-Onset Spinal Muscular Atrophy — Biogen Intends to File Marketing Applications for Nusinersen with Regulatory Authorities in the Coming Months — Biogen Exercises Option to Develop and Commercialize Nusinersen Globally —
http://www.biotechnologyevents.com/node/9638
http://www.biotechnologyevents.com/node/9032

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Updates for July 27, 2016

1) pSivida Corporation - pSivida's Medidur™ Maintains Same High Statistical Significance in Primary Endpoint through 12 Months in First Phase 3 Trial (p Less Than 0.00000001) - Incremental Risk of Elevated IOP Relative to Control Decreases Through Last Follow-up Visit
http://www.biotechnologyevents.com/node/10231

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Updates for July 26, 2016

1) Celgene Corporation - Celgene and LYSARC Provide Update on the Phase III ‘REMARC' Study of REVLIMID® Maintenance Treatment in Patients with Diffuse Large B-Cell Lymphoma Responding to First-Line R-CHOP Therapy
http://www.biotechnologyevents.com/node/11074

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Updates for July 25, 2016

1) Gilead Sciences, Inc. - European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV – If Approved, Truvada for PrEP in Combination with Safer Sex Practices Could Offer Uninfected Adults at High Risk a New Option to Reduce the Risk of Acquiring HIV –
http://www.biotechnologyevents.com/node/11100

2) Celsion Corporation - Celsion Announces Positive Data from the OVATION Study - An Immunotherapy Study of Newly Diagnosed Ovarian Cancer Patients - Second Cohort of Stage III and IV Patients Continues to Show Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel IL-12 DNA-based Immunotherapy, in Combination with the Standard of Care
http://www.biotechnologyevents.com/node/10593

3) Merrimack Pharmaceuticals, Inc. - Merrimack Announces ONIVYDE® Regimen Receives Positive CHMP Opinion in European Union
http://www.biotechnologyevents.com/node/10107

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Updates for July 22, 2016

1) Puma Biotechnology, Inc. - Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
http://www.biotechnologyevents.com/node/11767

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Updates for July 21, 2016

1) Amgen - Amgen And Allergan Announce Top-Line Results From Phase 3 Study Evaluating ABP 980 Compared With Trastuzumab In Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer
http://www.biotechnologyevents.com/node/10961

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Updates for July 19, 2016

1) Progenics Pharmaceuticals, Inc. - Valeant and Progenics Announce FDA Approves RELISTOR® Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-cancer Pain - Sales of RELISTOR tablets are expected to commence in the Third Quarter 2016
http://www.biotechnologyevents.com/node/10227

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Updates for July 12, 2016

1) CytRx Corporation - CytRx Announces Initial Results of Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcoma; Subsequent Analysis to Be Announced Fourth Quarter 2016
http://www.biotechnologyevents.com/node/6850

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Updates for July 11, 2016

1) Amgen Inc. - FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor - Repatha® (evolocumab) Pushtronex™ System Available to U.S. Patients in Early August -
http://www.biotechnologyevents.com/node/10953

2) TESARO, Inc. - ENGOT AND TESARO PARTNERSHIP GENERATES POSITIVE DATA FROM ENGOT-OV16/NOVA PHASE 3 TRIAL
http://www.biotechnologyevents.com/node/11325

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Updates for June 29, 2016

1) Galena Biopharma, Inc. - Galena Biopharma Discontinues NeuVax™ (nelipepimut-S) Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation
http://www.biotechnologyevents.com/node/5530

2) TESARO, Inc. - TESARO'S NIRAPARIB SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL FOR PATIENTS WITH OVARIAN CANCER IN BOTH COHORTS OF THE PHASE 3 NOVA TRIAL
http://www.biotechnologyevents.com/node/10568

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Updates for June 28, 2016

1) Gilead Sciences, Inc. - U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C – Epclusa is the First and Only All-Oral, Pan-genotypic Single Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead’s Third Sofosbuvir-Based Regimen –
http://www.biotechnologyevents.com/node/10710

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Updates for June 22, 2016

1) Emergent BioSolutions, Inc. - FDA Completes Pre-Approval Inspection of Emergent BioSolutions’ Large-Scale Manufacturing Facility for BioThrax
http://www.biotechnologyevents.com/node/6985

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Updates for June 15, 2016

1) Endo Pharmaceuticals, Inc. - Endo Announces FDA Advisory Committee Meeting For OPANA® ER
http://www.biotechnologyevents.com/node/11617

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Updates for June 14, 2016

1) Infinity Pharmaceuticals, Inc. - Infinity Reports Topline Results From DYNAMO™, A Phase 2 Monotherapy Study Of Investigational Molecule Duvelisib In Refractory Indolent Non-Hodgkin Lymphoma
http://www.biotechnologyevents.com/node/7202

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Updates for June 06, 2016

1) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients - Moderate-to-severe atopic dermatitis is a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities - These data, along with previous Phase 3 studies, will be part of a U.S. regulatory submission for dupilumab, which is on track for Q3 of 2016 -
http://www.biotechnologyevents.com/node/9286

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Updates for May 31, 2016

1) Amarin Corporation - Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules
http://www.biotechnologyevents.com/node/5773

2) BioMarin Pharmaceuticals Inc. - BioMarin Announces Withdrawal of Market Authorization Application for Kyndrisa™ (drisapersen) in Europe
http://www.biotechnologyevents.com/node/10190

3) Vertex Pharmaceuticals, Inc. - U.S. FDA Accepts for Priority Review Supplemental New Drug Application for the Use of ORKAMBI® (lumacaftor/ivacaftor) in Children with Cystic Fibrosis Ages 6 to 11 who have Two Copies of the F508del Mutation
http://www.biotechnologyevents.com/node/11064

4) Intercept Pharmaceuticals, Inc. - FDA Grants Accelerated Approval to Ocaliva™ (Obeticholic Acid) for the Treatment of Patients with PBC
http://www.biotechnologyevents.com/node/9097

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Updates for May 29, 2016

1) Vanda Pharmaceuticals, Inc. - Vanda Announces FDA Approval of the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults
http://www.biotechnologyevents.com/node/10554

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Updates for May 23, 2016

1) Exelixis, Inc. - Exelixis Announces Results from Randomized Phase 2 Trial CABOSUN Demonstrate Cabozantinib Significantly Improved Progression-Free Survival versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma
– Exelixis to consult with regulatory authorities to determine next steps in development and submission strategy for cabozantinib in first-line renal cell carcinoma –
http://www.biotechnologyevents.com/node/10099

2) Durect Corporation - DURECT Announces FDA Advisory Committee Meeting for REMOXY® - FDA's Tentative Date for Advisory Committee Meeting is August 5, 2016 and No Change to PDUFA Date of September 25, 2016
http://www.biotechnologyevents.com/node/11599

3) Pain Therapeutics, Inc. - PAIN THERAPEUTICS ANNOUNCES FDA ADVISORY COMMITTEE MEETING FOR REMOXY - - August 5th is FDA's Tentative Date for Advisory Committee Meeting - No Change to PDUFA Date -
http://www.biotechnologyevents.com/node/11600

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Updates for May 10, 2016

1) NewLink Genetics Corporation - NewLink Genetics Announces Results from Phase 3 IMPRESS Trial of Algenpantucel-L for Patients with Resected Pancreatic Cancer
http://www.biotechnologyevents.com/node/8843

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Updates for May 02, 2016

1) Regeneron Pharmaceuticals, Inc. - Regeneron Announces Positive Topline Results from Phase 2/3 Fasinumab Study in Patients with Osteoarthritis Pain
http://www.biotechnologyevents.com/node/11177

2) Biogen Idec, Inc. - iogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis - Positive Benefit-Risk Profile of ZINBRYTA Supported by Large Head-to-Head Phase 3 DECIDE Study -
http://www.biotechnologyevents.com/node/9913

3) Gilead Sciences, Inc. - European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV
http://www.biotechnologyevents.com/node/10492

4) Acadia Pharmaceuticals Inc. - FDA Approves ACADIA Pharmaceuticals’ NUPLAZID™ (pimavanserin) - The First Drug Approved for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis - U.S. Commercial Launch Planned for June 2016 - An Estimated 40 Percent of Parkinson’s Disease Patients Have Psychosis - Conference Call Scheduled on Monday, May 2 at 8:30 a.m. ET
http://www.biotechnologyevents.com/node/10542

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Updates for April 27, 2016

1) Dynavax Technologies Corporation - Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016
http://www.biotechnologyevents.com/node/11413

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Updates for April 26, 2016

1) Sarepta Therapeutics, Inc. - Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy
http://www.biotechnologyevents.com/node/10645

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Updates for April 25, 2016

1) Exelixis, Inc. - Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
http://www.biotechnologyevents.com/node/10670

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Updates for April 18, 2016

1) Emergent BioSolutions, Inc. - Emergent BioSolutions Submits sBLA for FDA Approval of Large-Scale Manufacturing of BioThrax in Building 55
http://www.biotechnologyevents.com/node/6985

2) Transition Therapeutics, Inc. - Transition Therapeutics Provides Update on Type 2 Diabetes Drug Candidate TT401
http://www.biotechnologyevents.com/node/11272

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Updates for April 14, 2016

1) Intercept Pharmaceuticals, Inc. - New Analyses of the Phase 3 POISE Trial of Ocaliva™ (Obeticholic Acid) for the Treatment of PBC Presented at EASL
http://www.biotechnologyevents.com/node/9096

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Updates for April 13, 2016

1) Durect Corporation - DURECT Announces FDA Acceptance of REMOXY® NDA, PDUFA Date of September 25, 2016 -
http://www.biotechnologyevents.com/node/6987

2) Pain Therapeutics, Inc. - FDA ACCEPTS REMOXY NDA FOR REVIEW, SETS PDUFA DATE OF SEPTEMBER 25, 2016 - Company Will Host Conference Call on Wednesday, April 13th, 8:30am EDT - Guest Speaker Invited to Discuss REMOXY's Target Market -
http://www.biotechnologyevents.com/node/6988

3) Clovis Oncology, Inc. - CLOVIS ONCOLOGY PROVIDES UPDATE ON FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING TO REVIEW ROCILETINIB FOR TREATMENT OF ADVANCED T790M-POSITIVE MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR NON-SMALL CELL LUNG CANCER
http://www.biotechnologyevents.com/node/11191

4) Repros Therapeutics Inc. - Repros Reports Positive Clinical Data for Vaginal Proellex® in Women With Severe Menstrual Bleeding Due to Uterine Fibroids - Primary endpoint of induction of amenorrhea met for both vaginal doses compared to placebo, p < 0.0011 - Proellex®-treated subjects reported a median 100% reduction in diary reports of menstrual bleeding product usage (PBAC) - Statistically significant reduction in fibroid size from baseline achieved for the combined active arms compared to increase in fibroid volume in placebo arm, p=0.0437 - Low dose oral data from a comparable study to be reported in Q2 2016 -
http://www.biotechnologyevents.com/node/9508

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Updates for April 12, 2016

1) Arena Pharmaceuticals Inc. - Arena Pharmaceuticals Reports Favorable Results from Phase 1b Multiple-Ascending Dose Clinical Trial of APD371
http://www.biotechnologyevents.com/node/11404

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Updates for April 11, 2016

1) Clovis Oncology, Inc. - FDA POSTS BRIEFING DOCUMENTS FOR ADVISORY COMMITTEE MEETING TO REVIEW CLOVIS ONCOLOGY’S ROCILETINIB FOR TREATMENT OF ADVANCED T790M-POSITIVE MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR NON-SMALL CELL LUNG CANCER
http://www.biotechnologyevents.com/node/11191

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Updates for April 07, 2016

1) Intercept Pharmaceuticals, Inc. - FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva™ (obeticholic acid) for the Treatment of PBC - PDUFA Date is May 29, 2016
http://www.biotechnologyevents.com/node/10836

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Updates for April 04, 2016

1) Progenics Pharmaceuticals, Inc. - Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR - Agency requests standard three-month extension to review additional solicited information - New PDUFA date set for July 19, 2016 -
http://www.biotechnologyevents.com/node/10236

2) Amicus Therapeutics Inc. - Amicus Therapeutics Receives Positive CHMP Opinion for Approval of Migalastat in Patients with Fabry Disease in European Union - Broad Label for All Fabry Patients with an Amenable Genetic Mutation -
http://www.biotechnologyevents.com/node/9456

3) Array BioPharma Inc. - Array BioPharma Announces Decision To Discontinue MILO Study In Ovarian Cancer
http://www.biotechnologyevents.com/node/7028

4) Regeneron Pharmaceuticals, Inc. - Sanofi and Regeneron Announce Positive Dupilumab Topline Results from Two Phase 3 Trials in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients - Dupilumab is first systemic therapy to show positive Phase 3 results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities -
http://www.biotechnologyevents.com/node/8436
http://www.biotechnologyevents.com/node/11172

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Updates for March 30, 2016

1) Acadia Pharmaceuticals Inc. - FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
http://www.biotechnologyevents.com/node/11086

2) Durect Corporation - DURECT Announces Resubmission of REMOXY® New Drug Application to the U.S. Food and Drug Administration
http://www.biotechnologyevents.com/node/6987

3) Pain Therapeutics, Inc. - Pain Therapeutics Resubmits REMOXY New Drug Application to the U.S. Food and Drug Administration -
REMOXY NDA Has Priority Review
http://www.biotechnologyevents.com/node/6988

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Updates for March 29, 2016

1) Keryx Biopharmaceuticals, Inc. - KERYX BIOPHARMACEUTICALS ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PIVOTAL PHASE 3 STUDY OF FERRIC CITRATE FOR THE TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE - Registration trial demonstrated statistically significant differences versus placebo for the primary and all pre-specified secondary endpoints - Majority of patients in the ferric citrate group (52 percent) achieved a 1 g/dL increase in hemoglobin vs. 19 percent in the placebo group - Safety profile consistent with previously reported clinical studies - Data support Keryx’s plan to submit a supplemental new drug application (sNDA) in the third quarter of 2016 seeking to expand ferric citrate’s indication -
http://www.biotechnologyevents.com/node/8925

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Updates for March 23, 2016

1) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Announce Positive Topline Results from Phase 3 Praluent® (alirocumab) Study in Patients Undergoing LDL Apheresis Therapy
http://www.biotechnologyevents.com/node/11391

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Updates for March 22, 2016

1) BioMarin Pharmaceuticals Inc. - BioMarin Phase 3 Study of Pegvaliase for Phenylketonuria (PKU) Meets Primary Endpoint of Blood Phenylalanine (Phe) Reduction (p<0.0001) - In 8-week Placebo-Controlled Portion No Benefit in Inattention or Mood Scores Were Observed
http://www.biotechnologyevents.com/node/11386

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Updates for March 16, 2016

1) Amgen, Inc. - Amgen Wins Patent Case On Repatha® (Evolocumab) - Proceedings on Damages and an Injunction Against Sanofi and Regeneron Will Follow
http://www.biotechnologyevents.com/node/11373

2) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Strongly Disagree with U.S. Jury Verdict in Ongoing Patent Litigation Regarding Praluent® (alirocumab) Injection and Will Appeal
http://www.biotechnologyevents.com/node/11372

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Updates for March 15, 2016

1) TESARO, Inc. - TESARO SUBMITS NEW DRUG APPLICATION FOR INTRAVENOUS ROLAPITANT TO THE U.S. FOOD AND DRUG ADMINISTRATION
http://www.biotechnologyevents.com/node/11322

2) Spectrum Pharmaceuticals / Ligand - FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection
http://www.biotechnologyevents.com/node/11223
http://www.biotechnologyevents.com/node/11224

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Updates for March 11, 2016

1) Sarepta Therapeutics, Inc. - Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - Advisory Committee Meeting Rescheduled for April 25, 2016 - PDUFA date for eteplirsen is May 26, 2016 -
http://www.biotechnologyevents.com/node/10645

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Updates for March 11, 2016

1) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Announce Topline Results of Phase 3 Monotherapy Study Demonstrating Superiority of Sarilumab vs. Adalimumab in Patients with Active Rheumatoid Arthritis
http://www.biotechnologyevents.com/node/11176

2) Amgen, Inc. - FDA Accepts Amgen's Supplemental Biologics License Application For The Expanded Use Of Enbrel® (Etanercept) To Treat Pediatric Patients With Chronic Severe Plaque Psoriasis
http://www.biotechnologyevents.com/node/11351

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Updates for March 10, 2016

1) Vericel Corporation - Vericel Announces Positive Top-Line Results From Phase 2b ixCELL-DCM Clinical Trial of Ixmyelocel-T in Patients With Heart Failure Due to Ischemic Dilated Cardiomyopathy - Study Meets Primary Endpoint of Reduction in Clinical Cardiac Events -
http://www.biotechnologyevents.com/node/5238

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Updates for March 03, 2016

1) BioMarin Pharmaceuticals Inc. - BioMarin Announces Positive Data From Cerliponase Alfa Program for Treatment of CLN2 Disease, a Form of Batten Disease, at 12th Annual WORLDSymposium(TM) 2016 - 80% Reduction in Clinical Disease Progression in One Year Compared to Natural History (p <0.0001) - Company Plans to Submit Marketing Applications Starting Mid-Year 2016 -
http://www.biotechnologyevents.com/node/7754

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Updates for March 02, 2016

1) Gilead Sciences, Inc. - U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection– Odefsey is the Smallest Single Tablet HIV Regimen –
http://www.biotechnologyevents.com/node/10252

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Updates for February 29, 2016

1) Biogen Idec, Inc. - Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix® (rFIXFc) for the Treatment of Hemophilia B
http://www.biotechnologyevents.com/node/10241

2) Gilead Sciences, Inc. - European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV
http://www.biotechnologyevents.com/node/10150

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Updates for February 23, 2016

1) AMAG Pharmaceuticals Inc. - AMAG Pharmaceuticals Announces FDA Approval of New Single-Dose, Preservative-Free Makena® (hydroxyprogesterone caproate injection) -
Company Plans for Full Commercial Launch of Makena Line Extension in Second Quarter of 2016
http://www.biotechnologyevents.com/node/10792

2) Medivation, Inc. - FDA Accepts for Review Supplemental New Drug Application for XTANDI(R) (enzalutamide) Capsules in Metastatic Castration-Resistant Prostate Cancer With Data From Head-to-Head Studies of Enzalutamide Versus Bicalutamide
http://www.biotechnologyevents.com/node/11293

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Updates for February 22, 2016

1) Amgen Inc. - Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis - FRAME Study Met All Primary Endpoints by Reducing the Incidence of New Vertebral Fracture Through 12 and 24 Months
http://www.biotechnologyevents.com/node/6100

2) Celldex Therapeutics, Inc. - Celldex Presents Preliminary Cohort Data from Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Harvest at the 2016 BMT Tandem Meeting
http://www.biotechnologyevents.com/node/9227

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Updates for February 19, 2016

1) Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin® (apaziquone for intravesical instillation)
http://www.biotechnologyevents.com/node/7115

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Updates for February 16, 2016

1) Gilead Sciences, Inc. - U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

2) Amgen Inc. - Phase 3 Study Demonstrates Aranesp® (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS) - First Phase 3 Data From Placebo-Controlled Study With an Erythropoiesis-Stimulating Agent (ESA) in Anemic Patients With MDS - Study Met Primary Endpoint and Key Secondary Endpoint of Erythroid Response
http://www.biotechnologyevents.com/node/11222

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Updates for February 15, 2016

1) Clovis Oncology, Inc. - CLOVIS ONCOLOGY ANNOUNCES ROCILETINIB NEW DRUG APPLICATION SCHEDULED FOR PRESENTATION AT UPCOMING FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING
http://www.biotechnologyevents.com/node/11191

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Updates for February 8, 2016

1) BioCryst Pharmaceuticals Inc. - BioCryst Announces Results From OPuS-2
http://www.biotechnologyevents.com/node/9490

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Updates for February 5, 2016

1) Vertex Pharmaceuticals, Inc. - Vertex Receives Complete Response Letter from U.S. FDA for Use of KALYDECO® (ivacaftor) in People with Cystic Fibrosis Ages 2 and Older with One of 23 Residual Function Mutations
http://www.biotechnologyevents.com/node/10626

2) Amgen Inc. - Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol
Study Meets Co-Primary Endpoints of LDL Cholesterol Reduction
http://www.biotechnologyevents.com/node/11123

3) Amgen Inc. - Phase 3 Study of BLINCYTO® (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Study Stopped Early for Efficacy
http://www.biotechnologyevents.com/node/8330

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Updates for February 1, 2016

1) Exelixis, Inc. - Exelixis Announces Positive Overall Survival Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma – Cabozantinib significantly improved overall survival as compared with everolimus – First therapy to demonstrate improvement in overall survival, progression-free survival, and objective response rate in a large, pivotal phase 3 study in previously treated renal cell carcinoma patients – Exelixis intends to share the data with U.S. and EU regulators, and to present the data at a medical meeting later in 2016 –
http://www.biotechnologyevents.com/node/7075

2) Transition Therapeutics, Inc. - Transition Therapeutics Announces Top Line Phase 2 Clinical Study Results of Diabetes Drug Candidate TT401
http://www.biotechnologyevents.com/node/8749

3) Acadia Pharmaceuticals Inc. - ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis - Advisory Committee Meeting Scheduled for March 29, 2016
http://www.biotechnologyevents.com/node/11086

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Updates for January 28, 2016

Exelixis, Inc. - Exelixis Announces U.S. FDA Deems New Drug Application Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma
http://www.biotechnologyevents.com/node/10670

Incyte Corporation - Incyte Announces Decision to Stop Phase 2 Sub-study of Ruxolitinib Plus Regorafenib in Patients with Metastatic Colorectal Cancer and High CRP
http://www.biotechnologyevents.com/node/11040

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Updates for January 22, 2016

1) Amgen Inc. - FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma - Pivotal Head-To-Head ENDEAVOR Study Shows Kyprolis and Dexamethasone Doubled Progression-Free Survival Versus Velcade® (Bortezomib) and Dexamethasone - Kyprolis Label Expansion Represents Critical Advancement for Patients With Relapsed or Refractory Multiple Myeloma, Offering New Option For Backbone Therapy - Approval Expands Kyprolis Indication and Converts Monotherapy Indication to Full Approval
http://www.biotechnologyevents.com/node/10308

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Updates for January 21, 2016

1) Alkermes, Inc. - Alkermes Announces Topline Results of FORWARD-3 and FORWARD-4, Two Phase 3 Studies of ALKS 5461 in Major Depressive Disorder - Neither Study Met Primary Endpoint; Additional Analyses of FORWARD-4 Provide Supportive Evidence of Efficacy - Third Efficacy Study, FORWARD-5, Will Recruit Additional Patients; Data May Provide Regulatory Path Forward for ALKS 5461 -
http://www.biotechnologyevents.com/node/8829
http://www.biotechnologyevents.com/node/8830

2) Sarepta Therapeutics, Inc. - FDA Postpones Advisory Committee Meeting to Review Eteplirsen Due to Severe Weather Storm in the Washington D.C. Area
http://www.biotechnologyevents.com/node/10645

3) OncoGenex Pharmaceuticals, Inc. - OncoGenex Announces Update on Phase 2 Spruce Trial in Previously Untreated Metastatic Non-Small Cell Lung Cancer
http://www.biotechnologyevents.com/node/6973

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Updates for January 19, 2016

1) Incyte Corporation - Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis
http://www.biotechnologyevents.com/node/10877

2) Merrimack Pharmaceuticals, Inc. - Updated Data Shows ONIVYDE® (irinotecan liposome injection) Combination Regimen Increased One Year Survival by 63% in Patients with Metastatic Pancreatic Cancer - Results based on an updated analysis from the NAPOLI-1 Phase 3 study in post-gemcitabine pancreatic cancer - Additional data to be presented at the ASCO GI 2016 conference indicate observed overall survival and progression free survival benefits for the ONIVYDE combination regimen compared to 5-FU and leucovorin alone were greatest among patients with the highest baseline CA19-9 levels
http://www.biotechnologyevents.com/node/7610

3) Acorda Therapeutics Inc. - Acorda to Acquire Biotie Therapies
http://www.biotechnologyevents.com/node/10879

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Updates for January 15, 2016

1) BioMarin Pharmaceuticals Inc. - FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Marketing Application in Europe Remains Under Review
http://www.biotechnologyevents.com/node/9830

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Updates for January 13, 2016

1) Gilead Sciences, Inc. - Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B - High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies -
http://www.biotechnologyevents.com/node/10850

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Updates for January 11, 2016

1) Threshold Pharmaceuticals, Inc. - Threshold Pharmaceuticals and Merck KGaA, Darmstadt, Germany Agree to Key Terms for the Licensing Back of All Rights to Evofosfamide to Threshold
http://www.biotechnologyevents.com/node/8917

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Updates for January 08, 2016

1) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Announce Sarilumab Biologics License Application Accepted for Review by US FDA
http://www.biotechnologyevents.com/node/10846

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Updates for January 07, 2016

1) Anacor Pharmaceuticals, Inc. - Anacor Pharmaceuticals Submits New Drug Application to the FDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis
http://www.biotechnologyevents.com/node/10723

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Updates for January 06, 2016

1) CTI Biopharma Corp. - CTI BioPharma And Baxalta Complete Submission Of New Drug Application For Pacritinib For Unmet Medical Need In Myelofibrosis
http://www.biotechnologyevents.com/node/9990

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Updates for January 05, 2016

1) Vericel Corporation - Vericel Submits Biologics License Application to the FDA for MACI for the Treatment of Cartilage Defects in the Knee
http://www.biotechnologyevents.com/node/10204

2) Exelixis, Inc. - Exelixis Announces Positive Results From Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma to be Presented at ASCO 2016 Genitourinary Cancers Symposium - Data further underscore clinical benefit of cabozantinib across subgroups of patients with advanced renal cell carcinoma - METEOR data are the foundation for the U.S. NDA filing submitted last month, EU filing planned for early 2016 -
http://www.biotechnologyevents.com/node/7075

3) Gilead Sciences, Inc. - Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C InfectionDownload - Final FDA Decision Anticipated by June 28, 2016 -
http://www.biotechnologyevents.com/node/10710

4) Depomed, Inc. - Depomed Announces Closing of Acquisition of U.S. Rights to Cebranopadol From Grunenthal - Adds Phase III-Ready, New Chemical Entity to Depomed’s Broad Commercial Portfolio
http://www.biotechnologyevents.com/node/10786

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Updates for January 04, 2016

1) Sunesis Pharmaceuticals, Inc. - Sunesis Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Application for Vosaroxin in AML
http://www.biotechnologyevents.com/node/10625

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Updates for December 24, 2015

1) Exelixis, Inc. - Exelixis Completes Submission of New Drug Application for Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma
http://www.biotechnologyevents.com/node/10670

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Updates for December 23, 2015

1) Vanda Pharmaceuticals, Inc. - European Medicines Agency Accepts Fanaptum® (iloperidone) Marketing Authorization Application for the Treatment of Schizophrenia in Adults
http://www.biotechnologyevents.com/node/10839

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Updates for December 22, 2015

1) pSivida Corporation - pSivida's Medidur™ Meets Primary Efficacy Endpoint in Phase 3 Trial: High Statistical Significance in Prevention of Recurrence of Posterior Uveitis (p Less Than 0.00000001) - Statistical Significance in Improvement in Visual Acuity and Reduction in Systemic Therapy -
http://www.biotechnologyevents.com/node/10231

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Updates for December 21, 2015

1) Momenta Pharmaceuticals, Inc. - Momenta Resumes Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study
http://www.biotechnologyevents.com/node/6692

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Updates for December 18, 2015

1) BioMarin Pharmaceuticals Inc. - BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa™ (drisapersen) New Drug Application by the PDUFA Date
http://www.biotechnologyevents.com/node/9830

2) Sarepta Therapeutics, Inc. - Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Advisory Committee Meeting Scheduled for January 22, 2016
http://www.biotechnologyevents.com/node/10645

3) Amgen Inc. - European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe
http://www.biotechnologyevents.com/node/9200

4) The Medicines Company, Inc. - The Medicines Company Agrees to Divest its Hemostasis Portfolio to Mallinckrodt plc
http://www.biotechnologyevents.com/node/10835

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Updates for December 17, 2015

1) Eli Lilly and Company - FDA Approves Basaglar® (insulin glargine injection), a Long-Acting Insulin Treatment
https://investor.lilly.com/releaseDetail.cfm?ReleaseID=947336

2) Neurocrine Biosciences, Inc. - Neurocrine Announces Successful Completion of Phase Ib T-Force Study of VMAT2 Inhibitor NBI-98854 in Adolescents and Children with Tourette Syndrome - Once-Daily Valbenazine was Safe and Well Tolerated with a 31% Reduction from Baseline in Tourette Symptoms after Two Weeks of Treatment - Phase II Study in Children and Adolescents Planned To Start in First Half of 2016 -
http://www.biotechnologyevents.com/node/9249

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Updates for December 16, 2015

1) Array BioPharma Inc. - Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma - Binimetinib achieves statistically significant progression free survival compared to chemotherapy - Regulatory submissions planned for the first half of 2016 --
http://www.biotechnologyevents.com/node/7027

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Updates for December 15, 2015

1) NewLink Genetics Corporation - NewLink Genetics Corporation Completes Enrollment of Phase 3 PILLAR Trial Evaluating Algenpantucel-L for Patients With Locally Advanced Pancreatic Cancer
http://www.biotechnologyevents.com/node/8842

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Updates for December 14, 2015

1) Zogenix, Inc. - Zogenix Announces FDA Acceptance of Investigational New Drug Application for ZX008 Phase 3 Clinical Trial in Dravet Syndrome
http://www.biotechnologyevents.com/node/10139

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Updates for December 11, 2015

1) Sangamo BioSciences, Inc. - Sangamo BioSciences Presents Phase 2 Clinical Data From Two SB-728-T HIV Studies - Preliminary Data Suggest Adenoviral Delivery Method Superior for Immune Stimulation and Control of Viral Load in the Absence of Antiretroviral Therapy (ART) -
http://www.biotechnologyevents.com/node/10100

2) Puma Biotechnology, Inc. - Puma Biotechnology Presents 3-Year Disease Free Survival Data from Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) at the 2015 San Antonio Breast Cancer Symposium
http://www.biotechnologyevents.com/node/8879

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Updates for December 10, 2015

1) ArQule, Inc. - ARQULE AND DAIICHI SANKYO ANNOUNCE COMPLETION OF ACCRUAL IN METIV-HCC PHASE 3 TRIAL OF TIVANTINIB FOR SECOND-LINE HEPATOCELLULAR CARCINOMA Planned interim analysis expected to occur early in the second quarter of 2016
http://www.biotechnologyevents.com/node/5978

2) Puma Biotechnology, Inc. - Puma Biotechnology Announces Results of Phase II Trial of PB272 in Neoadjuvant Treatment of HER2-Positive Locally Advanced Breast Cancer
http://www.biotechnologyevents.com/node/8877

3) Puma Biotechnology, Inc. - Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2015 San Antonio Breast Cancer Symposium - "Neratinib for ERBB2 mutant, HER2 non-amplified, metastatic breast cancer: preliminary analysis from SUMMIT – a multicenter, open-label, multi-histology phase II basket trial"
http://www.biotechnologyevents.com/node/8881

4) NewLink Genetics Corporation - NewLink Genetics Corporation Presents Preliminary Safety Data From Randomized Phase 2 Trial of Indoximod, an IDO Pathway Inhibitor, at San Antonio Breast Cancer Symposium
http://www.biotechnologyevents.com/node/7328

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Updates for December 09, 2015

1) OncoGenex Pharmaceuticals, Inc. - OncoGenex Announces Apatorsen Phase 2 Borealis-2 Trial Continues Following Successful Completion of Futility Analysis - Data Safety Monitoring Board Recommends Continuation of Trial as Planned in Bladder Cancer Patients
http://www.biotechnologyevents.com/node/6889

2) Oncothyreon, Inc. - Oncothyreon Announces Data for ONT-380 in HER2-Positive Breast Cancer Patients With and Without Brain Metastases at the San Antonio Breast Cancer Symposium
http://www.biotechnologyevents.com/node/8400

3) Galena Biopharma, Inc. - Galena Biopharma Presents Final GALE-401 Phase 2 Clinical Data at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition
http://www.biotechnologyevents.com/node/9205

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Updates for December 08, 2015

1) Gilead Sciences, Inc. - Phase 3 Results for Zydelig® With Bendamustine and Rituximab for Relapsed Chronic Lymphocytic Leukemia (CLL) Presented at American Society of Hematology Annual Meeting - Study Shows Statistically Significant Benefit for Zydelig in Progression-Free Survival -
http://www.biotechnologyevents.com/node/5886

2) Sunesis Pharmaceuticals, Inc. - Sunesis Pharmaceuticals Announces Submission of a Marketing Authorization Application for Vosaroxin for the Treatment of Acute Myeloid Leukemia in Europe
http://www.biotechnologyevents.com/node/10820

3) POZEN, Inc. - POZEN And Tribute Announce Plan To Proceed With Merger To Form Aralez Pharmaceuticals
http://www.biotechnologyevents.com/node/10192

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Updates for December 07, 2015

1) Zogenix, Inc. - Zogenix Announces New Efficacy and Safety Data on ZX008 for Treatment of Seizures in Dravet Syndrome
New Clinical Data Presented at 69th Annual American Epilepsy Society Meeting on the Use of Low-Dose Fenfluramine in Managing Seizures Associated With Dravet Syndrome
http://www.biotechnologyevents.com/node/10139

2) Sucampo Pharmaceuticals, Inc. - SUCAMPO COMPLETES ACQUISITION OF R-TECH UENO
http://www.biotechnologyevents.com/node/10500

3) Threshold Pharmaceuticals, Inc. - Threshold Pharmaceuticals Announces Its Two Phase 3 Studies Evaluating Evofosfamide Did Not Meet Primary Endpoints
Studies of Evofosfamide Combined With Chemotherapy in Advanced Pancreatic Cancer (MAESTRO) and Advanced Soft Tissue Sarcoma (TH-CR-406/SARC021) Did Not Meet Primary Endpoints of Improving Overall Survival With Statistical Significance
http://www.biotechnologyevents.com/node/5979
http://www.biotechnologyevents.com/node/5381

4) Ariad Pharmaceuticals, Inc. - ARIAD Announces Initiation of OPTIC-2L Randomized Phase 3 Trial of ponatinib vs. nilotinib in Second-Line Patients with Chronic-Phase Chronic Myeloid Leukemia
http://www.biotechnologyevents.com/node/10819

5) CTI Biopharma Corp. - Analysis of Pivotal Phase 3 Patient Outcomes by Subgroups Shows Treatment with Pacritinib Resulted in Consistent Rates of Reduction in Spleen Volume and Symptom Burden - Results support the effectiveness of pacritinib across intermediate or high-risk myelofibrosis patient subgroups analyzed
http://www.biotechnologyevents.com/node/5437

6) Incyte Corporation - Phase 3 RESPONSE-2 Study of Jakafi® (ruxolitinib) Meets Primary Endpoint - Patients with polycythemia vera without enlarged spleen treated with Jakafi achieved hematocrit control without phlebotomy
http://www.biotechnologyevents.com/node/10817

7) Amgen Inc. - Amgen Submits Application In Europe To Expand Indication Of Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma - Application Based on Pivotal Head-to-Head ENDEAVOR Study Showing Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) Plus Dexamethasone
http://www.biotechnologyevents.com/node/10818

8) Incyte Corporation - Two Phase 3 Studies Reinforce Sustained Benefits of Treatment with Jakafi® (ruxolitinib) in Patients with Myeloproliferative Neoplasms (MPNs) - COMFORT-II data demonstrate that patients with myelofibrosis treated with Jakafi achieved a 33 percent reduction in the risk of death after five years
http://www.biotechnologyevents.com/node/2056

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Updates for December 04, 2015

1) Gilead Sciences, Inc. - European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C - If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic Single Tablet Regimen for Chronic HCV in Europe - SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency -
http://www.biotechnologyevents.com/node/10816

2) Amgen Inc. - Amgen's First Biosimilar Marketing Authorization Application Submitted To European Medicines Agency For ABP 501 - Supported By Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis
http://www.biotechnologyevents.com/node/10815

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Updates for December 03, 2015

1) Progenics Pharmaceuticals Achieves Target Enrollment in its Phase 2b Pivotal Trial of Azedra™ - Evaluating the Ultra-Orphan Radiotherapeutic Candidate in Pheochromocytoma and Paraganglioma -
http://www.biotechnologyevents.com/node/7990

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Updates for December 02, 2015

1) OncoGenex Pharmaceuticals, Inc. - OncoGenex Announces Phase 3 AFFINITY Trial with Custirsen Continues Following Interim Analyses - Final Results Expected in Second Half of 2016
http://www.biotechnologyevents.com/node/10629

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Updates for December 01, 2015

1) Repros Therapeutics Inc. - Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene
http://www.biotechnologyevents.com/node/7991

2) CytRx Corporation - CytRx Announces the Completion of Enrollment in Pivotal Global Phase 3 Trial Ahead of Schedule - Top-line progression-free survival data now expected in the first half of 2016
http://www.biotechnologyevents.com/node/6850

3) Puma Biotechnology, Inc. - Puma Biotechnology Provides Update from Meeting with European Medicines Agency
http://www.biotechnologyevents.com/node/10800

4) Lexicon Pharmaceuticals, Inc. - Telotristat Etiprate Achieves Positive Top-line Results in Second Phase 3 Clinical Trial
http://www.biotechnologyevents.com/node/10812

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Updates for November 30, 2015

1) Arena Pharmaceuticals Inc. - Eisai and Arena Pharmaceuticals Announce FDA Acceptance of New Drug Application for Extended Release Formulation of Lorcaserin
http://www.biotechnologyevents.com/node/10799

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Updates for November 27, 2015

1) Amgen Inc. - Amgen's First Biosimilar Biologics License Application For ABP 501 Submitted To U.S. Food And Drug Administration - Supported by Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis
http://www.biotechnologyevents.com/node/10796

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Updates for November 25, 2015

1) Exelixis, Inc. - Exelixis Announces European Commission Approval of COTELLIC™ (Cobimetinib) for Use in Combination with Vemurafenib in Advanced BRAF V600 Mutation-Positive Melanoma
http://www.biotechnologyevents.com/node/10580

2) Impax Laboratories Inc. - Impax Receives European Commission Marketing Authorization for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's Disease
http://www.biotechnologyevents.com/node/9422

3) Emergent BioSolutions, Inc. - FDA Approves Emergent BioSolutions' BioThrax for Post-Exposure Prophylaxis
http://www.biotechnologyevents.com/node/9393

4) BioMarin Pharmaceuticals Inc. - FDA Advisory Committee Discusses Clinical Data Package for BioMarin's Kyndrisa(TM) (drisapersen) for the Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - If Approved, Kyndrisa Would Become the First Disease-Modifying Therapy for Patients With Duchenne Muscular Dystrophy in the United States Amenable to Exon 51 Skipping -
http://www.biotechnologyevents.com/node/10648

5) Eli Lilly and Company - FDA Approves Portrazza™ (necitumumab) for Specific Type of Lung Cancer
https://investor.lilly.com/releaseDetail.cfm?ReleaseID=944351

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Updates for November 24, 2015

1) BioMarin Pharmaceuticals Inc. - BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) Announced Today the Stock is Halted - BioMarin Posts Presentation From FDA Advisory Committee Meeting for Kyndrisa(TM) (drisapersen) for the Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
http://www.biotechnologyevents.com/node/10648

2) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Announce 18,000-Patient ODYSSEY OUTCOMES Trial of Praluent® Injection Fully Enrolled
http://www.biotechnologyevents.com/node/9008

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Updates for November 23, 2015

1) POZEN, Inc. - POZEN And Tribute Provide Update On Pending Combination Transactions - POZEN and Tribute Evaluating Canadian Domicile for Aralez Pharmaceuticals -
http://www.biotechnologyevents.com/node/10192

2) CytRx Corporation - Aldoxorubicin Continues To Demonstrate Positive Clinical Activity In Phase 2 Glioblastoma Trial - OVERALL SURVIVAL NOT YET REACHED; 57% OF PATIENTS CONTINUE TO BE FOLLOWED - CYTRX PLANS TO DISCUSS PIVOTAL TRIAL DESIGN WITH THE FDA
http://www.biotechnologyevents.com/node/8274

3) AMAG Pharmaceuticals, Inc. - AMAG Pharmaceuticals Responds to Recent Complete Response Letter From the FDA for the Single-Dose, Preservative-Free Vial of Makena(R)
http://www.biotechnologyevents.com/node/10792

4) CTI Biopharma Corp. - CTI BioPharma Initiates Rolling Submission of U.S. New Drug Application for Pacritinib for the Treatment of Patients with Myelofibrosis - Completion of NDA Submission Expected Before the End of 2015 -
http://www.biotechnologyevents.com/node/9990

5) Gilead Sciences, Inc. - European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection – Gilead’s First TAF-based Single Tablet Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens –
http://www.biotechnologyevents.com/node/10493

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Updates for November 20, 2015

1) Depomed, Inc. - Depomed Comments on Horizon Withdrawal of Offer to Acquire Company - Withdrawal Follows Court Ruling Enjoining Horizon's Exchange Offer and Proxy Solicitation -
http://www.biotechnologyevents.com/node/10276

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Updates for November 18, 2015

1) Depomed, Inc. - Depomed Acquires U.S. Rights to Late-Stage, First-in-Class Pain Product from Grunenthal
http://www.biotechnologyevents.com/node/10786

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Updates for November 17, 2015

1) Infinity Pharmaceuticals, Inc. - Infinity Announces Completion Of Target Enrollment In DUO™, A Phase 3 Study Evaluating Duvelisib In Chronic Lymphocytic Leukemia
http://www.biotechnologyevents.com/node/7841

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Updates for November 16, 2015

1) Gilead Sciences, Inc. - Gilead’s Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia - Interim Analyses Results from Study 115 to be Presented as a Late-Breaking Abstract at the American Society of Hematology (ASH) Annual Meeting -
http://www.biotechnologyevents.com/node/5886

2) Clovis Oncology, Inc. - CLOVIS ONCOLOGY ANNOUNCES REGULATORY UPDATE FOR ROCILETINIB NDA FILING - Mid-Cycle Communication Meeting with FDA completed - Additional clinical information for 500mg and 625mg BID dose groups to be provided by the Company today -
http://www.biotechnologyevents.com/node/9979

3) The Medicines Company, Inc. - Federal Circuit overturns District Court decision on Angiomax patents; Grants The Medicines Company’s request for rehearing of appeal
http://www.biotechnologyevents.com/node/8497

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Updates for November 13, 2015

1) Momenta Pharmaceuticals, Inc. - Momenta Announces Temporary Pause of Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study
http://www.biotechnologyevents.com/node/6692

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Updates for November 11, 2015

1) Roche - FDA approves Roche’s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) in advanced melanoma
http://www.roche.com/media/store/releases/med-cor-2015-11-11.htm

2) Exelixis, Inc. - FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma
http://www.biotechnologyevents.com/node/9465

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Updates for November 10, 2015

1) Isis Pharmaceuticals, Inc. - Isis Pharmaceuticals Earns $2.8M for Advancing ISIS-DMPK-2.5 Rx in Patients with Myotonic Dystrophy Type I
http://www.biotechnologyevents.com/node/9708

2) Amgen Inc. - Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab - First Completed Phase 3 Study of Adalimumab Biosimilar in the Treatment of Patients With Moderate-to-Severe Rheumatoid Arthritis
http://www.biotechnologyevents.com/node/9621

3) Paratek Pharmaceuticals, Inc. - Paratek Initiates Omadacycline Phase 3 Clinical Study in Community Acquired Bacterial Pneumonia (CABP) - Dosing initiated in second of two Phase 3 registration studies for Paratek's omadacycline - Phase 3 program designed to support approval in two indications: acute bacterial skin and skin structure infections and community acquired bacterial pneumonia -
http://www.biotechnologyevents.com/node/10782

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Updates for November 09, 2015

1) ImmunoGen, Inc. - Treatment Response to ImmunoGen's Mirvetuximab Soravtansine Found to be Substantially Greater in Ovarian Cancer with High Expression of Folate Receptor Alpha - Objective response on mirvetuximab soravtansine in nine of ten (90%) patients with high amounts of target on cancer cells; majority of these responders remained on treatment for at least 24 weeks - Most patients with ovarian cancer found to have high or medium expression of target - FORWARD I ovarian cancer trial on track to begin in late 2015 - intended to support potential Accelerated Approval pathway -
http://www.biotechnologyevents.com/node/7980

2) Akcea Therapeutics - Isis Pharmaceuticals Reports Positive Clinical Data From Lp(a) Lowering Drugs - Webcast to review data scheduled for Sunday, November 8 at 1:00 p.m. Eastern Time -
http://www.biotechnologyevents.com/node/8954

3) Regeneron Pharmaceuticals, Inc. - Regeneron and Sanofi Present Results from Pivotal Phase 3 Study of Sarilumab at American College of Rheumatology Annual Meeting
Data Show Significant Improvement in Signs and Symptoms and Physical Function in Rheumatoid Arthritis Patients who were Inadequate Responders to or Intolerant of TNF-Alpha Inhibitors (TNF-IR) - Companies to host Investor Conference Call on sarilumab on Monday, Nov. 9 at 7:00 a.m. PT -
http://www.biotechnologyevents.com/node/6106

4) Incyte Corporation - Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis
Once-daily oral baricitinib significantly improved all seven components of ACR response versus injectable adalimumab
Patient-reported pain, joint stiffness, fatigue and physical function scores significantly improved with baricitinib compared to adalimumab
Detailed results from pivotal phase 3 study RA-BEAM presented at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting
http://www.biotechnologyevents.com/node/6135

5) Incyte Corporation - Lilly and Incyte Announce Patients Treated with Baricitinib Demonstrated Significant Improvement in Signs and Symptoms of Rheumatoid Arthritis Compared with Methotrexate - Compared to methotrexate, baricitinib as monotherapy or in combination with methotrexate demonstrated improvements in all ACR components as early as week 1 and maintained through 52 weeks - Both baricitinib regimens were superior to methotrexate monotherapy in inducing clinical remission, using measures such as SDAI, at weeks 24 and 52 - Baricitinib plus methotrexate also demonstrated significant inhibition of progressive radiographic structural joint damage measured using van der Heijde modified Sharp Score versus methotrexate alone at weeks 24 and 52
http://www.biotechnologyevents.com/node/6969

6) Amgen Inc. - FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide
http://www.biotechnologyevents.com/node/10496

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Updates for November 06, 2015

1) Discovery Labs Inc. - Discovery Labs to Announce Results from AEROSURF® Phase 2a Expansion Clinical Trial
http://www.biotechnologyevents.com/node/10146

2) OXiGENE, Inc. - OXIGENE ANNOUNCES POSITIVE INITIAL DATA FROM PHASE 1B STUDY OF CA4P IN COMBINATION WITH PAZOPANIB IN PATIENTS WITH ADVANCED RECURRENT OVARIAN CANCER - BASED ON POSITIVE SAFETY DATA AND PRELIMINARY SIGNS OF EFFICACY, STUDY EXPECTED TO ADVANCE TO PHASE 2 PORTION IN EARLY 2016 -
http://www.biotechnologyevents.com/node/10781

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Updates for November 05, 2015

1) Gilead Sciences, Inc. - U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection – Gilead’s First TAF-based Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens –
http://www.biotechnologyevents.com/node/9392

2) Aegerion Pharmaceuticals - Aegerion Pharmaceuticals Announces Postponement of Third Quarter 2015 Financial Results Conference Call
http://www.biotechnologyevents.com/node/10777

3) Isis Pharmaceuticals, Inc. - Isis Pharmaceuticals and Akcea Therapeutics Announce Start of Phase 3 Study of Volanesorsen in Patients with Familial Partial Lipodystrophy - Trial marks second study for volanesorsen in a rare, genetic lipid disorder -
http://www.biotechnologyevents.com/node/10775

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Updates for November 02, 2015

1) Acadia Pharmaceuticals Inc. - ACADIA Pharmaceuticals Announces FDA Priority Review of NUPLAZID™ (Pimavanserin) New Drug Application for Parkinson’s Disease Psychosis - PDUFA Date Set for May 1, 2016 -
http://www.biotechnologyevents.com/node/10542

2) Dyax Corporation - Shire to Acquire Dyax Corp, Expanding and Extending Industry-Leading Hereditary Angioedema (HAE) Portfolio - Lead pipeline product, DX-2930, is a Phase 3-ready asset, offering potentially transformative prophylactic therapy for HAE -
http://www.biotechnologyevents.com/node/10731

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