21:26 , Dec 4, 2018 |  BC Extra  |  Politics & Policy

Biosimilar makers back Pfizer in call to end misleading brand marketing

A group of biosimilar manufacturers including Pfizer Inc. (NYSE:PFE) urged FDA to produce supplemental guidance clarifying how to comply with existing law when communicating about biosimilars. The Biosimilars Forum sent its plea in a letter...
17:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

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...
21:15 , Nov 2, 2018 |  BC Extra  |  Company News

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 Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
19:55 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Coherus' Neulasta biosimilar

Coherus Biosciences Inc. (NASDAQ:CHRS) said FDA approved Udenyca pegfilgrastim-cbqv to treat cancer patients receiving myelosuppressive chemotherapy. Udenyca is the second FDA-approved biosimilar of neutropenia drug Neulasta drug pegfilgrastim. The European Commission also approved Udenyca for...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
22:56 , Jun 25, 2018 |  BC Extra  |  Company News

CHMP interactions delaying Coherus biosimilar timeline

Coherus Biosciences Inc. (NASDAQ:CHRS) lost $1.80 (10%) to $15.40 on Monday after it disclosed that EMA's CHMP will require further interactions with the company in order to issue an opinion on its pending MAA for...
18:20 , May 25, 2018 |  BC Week In Review  |  Financial News

Coherus raises $75M in follow-on

Coherus BioSciences Inc. (NASDAQ:CHRS) raised $75 million late on May 22 through the sale of 5.2 million shares at $14.50 in a follow-on underwritten by J.P. Morgan, Citigroup, Mizuho, Baird, Maxim Group and H.C. Wainwright....