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...
20:41 , Oct 5, 2018 |  BC Week In Review  |  Company News

Momenta cutting biosimilar programs, headcount

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said it plans to terminate five biosimilar development programs under its 2016 co-development deal with Mylan N.V. (NASDAQ:MYL) and reduce headcount by about 50% to focus on its novel pipeline. The...
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....
19:55 , May 23, 2018 |  BC Extra  |  Financial News

Coherus raises $75M in follow-on

Coherus BioSciences Inc. (NASDAQ:CHRS) raised $75 million 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. The price is a...
19:41 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA accepts resubmitted Coherus biosimilar BLA for review

Coherus BioSciences Inc. (NASDAQ:CHRS) said FDA accepted for review a resubmitted BLA for CHS-1701, a proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Its BSUFA date is Nov. 3. FDA issued a...
19:08 , May 4, 2018 |  BC Week In Review  |  Clinical News

Coherus resubmits BLA for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) resubmitted a BLA for CHS-1701, its biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). FDA issued a complete response letter for the biosimilar last year, and Coherus said Thursday...