BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BioCentury | Apr 6, 2019
Finance

Room to rally in 2Q

Strong small and mid-cap performance coupled with robust M&A has brought the sector back from 4Q18 correction territory, and chances are good for the momentum to continue given the ample capital ready to be recycled...
BioCentury | Apr 5, 2019
Company News

Sandoz resubmits BLA for Neulasta biosimilar

Sandoz said it resubmitted a BLA to FDA for LA-EP2006 to treat neutropenia in patients with non-myeloid malignancies receiving myelosuppressive drugs. LA-EP2006 is a biosimilar of Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). The resubmission from...
BioCentury | Oct 6, 2018
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...
BioCentury | Sep 28, 2018
Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
BioCentury | Sep 21, 2018
Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
BioCentury | Jun 30, 2018
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...
BioCentury | Jun 25, 2018
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...
BioCentury | Jun 8, 2018
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....
BioCentury | Jun 4, 2018
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....
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