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Regulatory Event - Watch List 09/19/16

Submitted by Biotech Team on Mon, 09/19/2016 - 08:22.

Updated Regulatory Watch List as of: 09/19/16

The following is a list of companies with near term regulatory events pending:

US Approval

FDA PDUFA Date (FDA Decision date)

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Emergent BioSolutions, Inc. - August 15, 2016
BioThrax Building 55 licensure - http://www.biotechnologyevents.com/node/11717 . (APPROVED)

Portola Pharmaceuticals, Inc. - August 17, 2016
Andexanet alfa - http://www.biotechnologyevents.com/node/11718

Sanofi - August 22,2016
Insulin Glargine and Lixisenatide - http://www.biotechnologyevents.com/node/10857

Amgen Inc. - August 24, 2016
Calcimimetic Etelcalcetide (AMG 416) - http://www.biotechnologyevents.com/node/10496

Amgen Inc. - September 1, 2016
BLINCYTO sNDA ALL - http://www.biotechnologyevents.com/node/11316 . (APPROVED)

Aralez Pharmaceuticals Inc. - September 14, 2016
YOSPRALA - http://www.biotechnologyevents.com/node/11405 . (APPROVED)

Amgen Inc. - September 25, 2016
ABP 501 (Humira) (adalimumab) Biosimilar - http://www.biotechnologyevents.com/node/10796 . (APPROVED)

DURECT Corporation - September 25, 2016
REMOXY - http://www.biotechnologyevents.com/node/6987 . (COMPLETE RESPONSE LETTER)

Pain Therapeutics, Inc. - September 25, 2016
REMOXY - http://www.biotechnologyevents.com/node/6988 . (COMPLETE RESPONSE LETTER)

Arena Pharmaceuticals, Inc. - September 30, 2016
Lorcaserin Extended Release - http://www.biotechnologyevents.com/node/10799

Vertex Pharmaceuticals, Inc. - September 30, 2016
Orkambi - http://www.biotechnologyevents.com/node/11606 . (APPROVED)

Egalet U.S. - October 14, 2016
ARYMO - http://www.biotechnologyevents.com/node/11732

Medivation, Inc. - October 22, 2016
XTANDI - sNDA metistatic castration resistan prostate cancer - http://www.biotechnologyevents.com/node/11293

Regeneron Pharmaceuticals, Inc. / Sanofi - October 30, 2016
Sarilumab - http://www.biotechnologyevents.com/node/10846 . (Complete Response Letter)

Amgen Inc. - November 5, 2016
Etanercept - http://www.biotechnologyevents.com/node/11351 . (APPROVED)

Gilead Sciences, Inc. - November 11, 2016
Tenofovir Alafenamide (TAF) - http://www.biotechnologyevents.com/node/10850

Valeant Pharmaceuticals, Inc. - November 16, 2016
Brodalumab - http://www.biotechnologyevents.com/node/11733

Dynavax Technologies Corporation - December 15, 2016
Heplisav-B - http://www.biotechnologyevents.com/node/11413 . (COMPLETE RESPONSE LETTER)

Spectrum Pharmaceuticals, Inc. - December 19, 2016
EOquin - http://www.biotechnologyevents.com/node/7115

Advanced Accelerator Applications S.A. - December 28, 2016
Lutathera - http://www.biotechnologyevents.com/node/11760

Vericel Corporation - January 03, 2017
MACI - http://www.biotechnologyevents.com/node/10204 . (APPROVED)

Pfizer - January 07, 2017
Crisaborole Topical Ointment, 2% - http://www.biotechnologyevents.com/node/10723

TESARO, Inc. - January 11, 2017
ROLAPITANT - http://www.biotechnologyevents.com/node/11322

BioMarin Pharmaceutical, Inc. - January 27, 2017
Cerliponase - http://www.biotechnologyevents.com/node/11833

Synergy Pharmaceuticals, Inc. - January 29, 2017
Plecanatide - http://www.biotechnologyevents.com/node/11688

Clovis Oncology, Inc. - February 23, 2017
Rucaparib - http://www.biotechnologyevents.com/node/11337 . (APPROVED)

Roche - March 28, 2017
Ocrelizumab - http://www.biotechnologyevents.com/node/12303

Regeneron Pharmaceuticals, Inc. - March 29, 2017
Dupilumab - http://www.biotechnologyevents.com/node/12214
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Neurocrine Biosciences, Inc. - April 11, 2017
Valbenazine - http://www.biotechnologyevents.com/node/11199

Incyte Corporation/Eli Lilly - April 19, 2017
Baricitinib - http://www.biotechnologyevents.com/node/10877

Biogen - April 28, 2017
Nusinerseen - http://www.biotechnologyevents.com/node/12184

Ionis Pharmaceuticals, Inc. - April 28, 2017
Nusinerseen - http://www.biotechnologyevents.com/node/12185 . (APPROVED)

Ariad Pharmaceuticals, Inc. - April 29, 2017
Brigatinib - http://www.biotechnologyevents.com/node/11308

Coherus BioSciences, Inc. - June 09, 2017
CHS-1701 (Neulasta) - http://www.biotechnologyevents.com/node/12338

Array BioPharma Inc. - June 30, 2017
Binimetinib - http://www.biotechnologyevents.com/node/11665

TESARO, Inc. - June 30, 2017
Niraparib - http://www.biotechnologyevents.com/node/12113

Puma Biotechnology, Inc. - July 20, 2017
Neratinib - http://www.biotechnologyevents.com/node/11767

Amgen/Allergan - September 15, 2017
ABP-215 - http://www.biotechnologyevents.com/node/12257

Ligand Pharmaceuticals, Inc. - October 24, 2017
Baxdela - http://www.biotechnologyevents.com/node/12234

Innoviva, Inc. - November 21, 2017
FF/UMEC/VI - http://www.biotechnologyevents.com/node/12262

GSK - November 21, 2017
FF/UMEC/VI - http://www.biotechnologyevents.com/node/12262

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FDA Advisory Committee Meetings

Amgen Inc. - July 12, 2016
ABP 501 - Biosimilar Humira - http://www.biotechnologyevents.com/node/11620 . (Results not disclosed)

Valeant Pharmaceuticals, Inc. - July 19, 2016
Brodalumab injection - http://www.biotechnologyevents.com/node/11701 . (Committee voted 18 to 0 in favor of approval)

Egalet Corporation - August 4, 2016
morphine sulfate extended-release - http://www.biotechnologyevents.com/node/11712 . (Committee voted 18 to 1 in favor of approval)

Allergan/Serenity Pharmaceuticals, LLC - October 19, 2016
Desmopressin - http://www.biotechnologyevents.com/node/11906

Cempra, Inc. - November 4, 2016
Solithromycin - http://www.biotechnologyevents.com/node/12094

Dynavax Technologies Corporation - November 16, 2016
Heplisav-B - http://www.biotechnologyevents.com/node/11904 . (CANCELLED)

Neurocrine BioSciences, Inc. - February 16, 2017
INGREZZA - http://www.biotechnologyevents.com/node/12267

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European Regulatory Events
All of the following events are CHMP Opinions unless otherwise specified.

The Committee for Medicinal Products for Human Use (CHMP) meets once a month for a four day period and opinions are announced the day following the meeting period. The regulatory process from start to CHMP opinion averages approximately one year. The meetings of the CHMP are not public. Currently, no agendas or minutes of the meetings are published. The dates listed for the events below are approximations based on the date of filing, an assumption of a one year examination period for standard review and a 10 month period for accelerated review and the meeting dates for the calculated month. Investors should take these facts into consideration when using these dates and always treat them as ESTIMATES.

A list of future CHMP meetings can be found on the EMA website. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/07/WC500...

A comparison of review times for the EMA and FDA can be found on this FDA website. Note: the EMA has 67 days after the CHMP opinion to file its decision.
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276421.htm

A recent study comparing review times between the two agencies, titled: "Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?" can be found at the following address:
Abstract - http://www.ncbi.nlm.nih.gov/pubmed/26013294
Full article - https://www.researchgate.net/publication/277336967_Priority_review_drugs...

Note: the presence of the above links on our website is for information purposes only, we at BiotechnologyEvents.com, do not endorse or make any assessment of the validity of the content of the above studies.

After each CHMP meeting, a meeting report and a press release are published on the Agency’s website. In addition, summaries of opinions adopted during each meeting in respect of specific medicines are published on the Agency's website. These express the opinion of the CHMP on new marketing application dossiers from pharmaceutical companies, on referral procedures and on other issues on which the Committee is required to provide an opinion.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landin...

A positive CHMP Opinion is not binding, however EMA approval usually follows. The EMA has 67 days after the CHMP opinion to file its decision.

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Exelixis, Inc. / Ipsen - September 16, 2016
Cabozantinib - Renal cell carcinoma - http://www.biotechnologyevents.com/node/10858

Amgen Inc. - September 16, 2016
Etelcalcetide (AMG 416) - http://www.biotechnologyevents.com/node/10541

Intercept Pharmaceuticals, Inc. - September 16, 2016
Obeticholic acid (OCA) PBC - http://www.biotechnologyevents.com/node/10245

Clovis Oncology, Inc. - November 11, 2016
Rociletinib (CO-1686) - http://www.biotechnologyevents.com/node/11338

Incyte Corporation / ELi Lilly - November 11, 2016
Baricitinib (INCB-28050) - http://www.biotechnologyevents.com/node/11218

Vanda Pharmaceuticals, Inc. - December 16, 2016
Fanapt (Iloperidone) - http://www.biotechnologyevents.com/node/10839

Amgen Inc. - December 16, 2016
ABP 501 (Humira) (adalimumab) Biosimilar - http://www.biotechnologyevents.com/node/10815

Sunesis Pharmaceuticals, Inc. - December 16, 2016
Vosaroxin (Voreloxin) AML - http://www.biotechnologyevents.com/node/10625

Gilead Sciences, Inc. - March 24, 2017
Tenofovir alafenamide (TAF) (GS-7340) Hep B - http://www.biotechnologyevents.com/node/11360

TESARO, Inc. - April 21, 2017
Rolapitant - http://www.biotechnologyevents.com/node/11323

AVEO Oncology - June 23, 2017
Tivozanib - Renal Cell Carcinoma - http://www.biotechnologyevents.com/node/11428

Puma Biotechnology, Inc. - September 15, 2017
Neratinib (PB-272) Breast cancer HER-2 positive - http://www.biotechnologyevents.com/node/10800

Amgen Inc. / UCB - September 15, 2017
Romosozumab (AMG-785) PMO - http://www.biotechnologyevents.com/node/11796

Cempra, Inc. - September 15, 2017
Solithromycin CAP - http://www.biotechnologyevents.com/node/11748

Ionis Pharmaceuticals, Inc. - September 15, 2017
Nusinersen - http://www.biotechnologyevents.com/node/12186

Biogen - September 15, 2017
Nusinersen - http://www.biotechnologyevents.com/node/12187

BioMarin Pharmaceuticals Inc. - September 15, 2017
Brineura™ (Cerliponase Alfa) - http://www.biotechnologyevents.com/node/11568

Repros Therapeutics Inc. - October 13, 2017
Enclomiphene citrate - http://www.biotechnologyevents.com/node/11370

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