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...
16:46 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA approves first Neulasta biosimilar

FDA approved Fulphila pegfilgrastim-jmdb from Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON), their biosimilar of neutropenia drug Neulasta from Amgen Inc. (NASDAQ:AMGN). FDA said Fulphila is the first approved biosimilar of the pegylated G-CSF. Specifically,...
23:08 , Jun 4, 2018 |  BC Extra  |  Company News

FDA approves first Neulasta biosimilar

FDA approved Fulphila pegfilgrastim-jmdb from Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON), their biosimilar of neutropenia drug Neulasta from Amgen Inc. (NASDAQ:AMGN). FDA said Fulphila is the first approved biosimilar of the pegylated G-CSF. Specifically,...
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...
22:57 , May 16, 2018 |  BC Extra  |  Company News

Management tracks: Novartis, Aileron

Novartis AG (NYSE:NVS; SIX:NOVN) said General Counsel Felix Ehrat will retire, effective June 1, in light of Novartis' payments to a consultancy owned by Michael Cohen. "As a co-signatory with our former CEO, I take...
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...
17:08 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

Coherus plans to resubmit BLA for Neulasta biosimilar

In its FY17 earnings, Coherus BioSciences Inc. (NASDAQ:CHRS) said it will resubmit a BLA for CHS-1701, with plans to launch the product in the U.S. next half. The company, which in November had said it...