"We're planning for success," John Thero told Scrip in an interview, where he talked about the upcoming US advisory committee meeting for Vascepa, commercial expansion plans and deflected questions about a big pharma buyout.
Amarin has one big FDA review meeting to go
Amarin Corp. PLC is heading into a US Food and Drug Administration Advisory Committee meeting for Vascepa (icosapent ethyl) with an optimistic outlook and an eye towards coming out on the other side with a big commercial launch.
"We're planning for success," CEO John Thero told Scrip during an interview. Anything different would be a huge blow...
The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.
The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.
Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.