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1:04 PM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves direct-to-consumer test, warns against others

After authorizing a genetic test from 23andMe Inc. (Mountain View, Calif.), FDA issued a warning against using unapproved tests to guide medical decisions. On Oct. 31, FDA said the Personal Genome Service Pharmacogenetic Reports test from...
12:15 PM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Empliciti plus pomalidomide and dexamethasone for MM

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA approved an sBLA for Empliciti elotuzumab in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma patients who have received at least two prior therapies, including lenalidomide...
12:15 PM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
11:31 AM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Priority Review for Dupixent in adolescent atopic dermatitis

Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA accepted and granted Priority Review to an sBLA for Dupixent dupilumab to treat adolescents ages 12 to 17 with moderate to severe atopic dermatitis whose...
10:31 AM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS; SIX:NOVN)...
9:54 AM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel backs Sage's postpartum depression candidate under REMS

A joint FDA panel voted 17-1 in favor of the benefit-risk profile for Zulresso brexanolone from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD) when administered in certified facilities by qualified staff under a...
9:31 AM, Nov 09, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
12:59 PM, Nov 02, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Symkevi, Kalydeco combination for cystic fibrosis

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said the European Commission approved Symkevi tezacaftor/ivacaftor in combination with Kalydeco ivacaftor in cystic fibrosis patients 12 and older. The combination is approved in patients with two copies of the F508del mutation...
12:58 PM, Nov 02, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Sanofi gets Priority Review for dengue vaccine

Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted and granted Priority Review to a BLA for Dengvaxia dengue tetravalent vaccine. The PDUFA date is May 1, 2019. If approved, Dengvaxia "would represent the first and only medical...
12:58 PM, Nov 02, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Jazz's Xyrem approved for pediatric narcolepsy with cataplexy

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA approved an sNDA for Xyrem sodium oxybate to treat cataplexy, or excessive daytime sleepiness, in narcolepsy patients ages seven and older. The drug was previously approved only for adults. The...

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