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 approval...
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 of...
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 of...
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. The...
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 5%...
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 complete...
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...
21:34 , May 3, 2018 |  BC Extra  |  Company News

Coherus resubmits BLA for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) gained $2.20 (17%) to $14.90 on Thursday after resubmitting a BLA for CHS-1701, its biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). FDA issued a complete response letter for...
22:47 , Apr 24, 2018 |  BC Extra  |  Company News

Amgen considering risk-based Aimovig pricing

On a conference call to discuss 1Q18 earnings call, Amgen Inc. (NASDAQ:AMGN) EVP of Global Commercial Operation Anthony Hooper said the biopharma is "prepared to talk to payers about risk-based contracts with Aimovig." This quarter, Amgen...