The restructuring of cardiovascular drugmaker Amarin means the layoff of about 30% of staff. Sales of Vascepa, the company’s only commercialized product, have suffered as generic versions gain traction in the market.
An analyst wrote that a best-case scenario for Amarin is that it may take 2-3 years for generic versions of Vascepa to hit the market. But the company has likely lost its luster as an acquisition target.
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While there were also bright spots - like CMS' decision on CAR-T therapy - several biopharma companies experienced unrelated setbacks this week that caused their shares to tank.
The Food and Drug Administration just OKed biopharma company Amarin to promote its only drug, Vascepa, for off-label use.
Reads about Amarin Pharma's First Amendment showdown with the FDA over the issue of off label drugs. Also it turns out Blue Bell Creameries knew that listeria was present in one of its factories as early as 2013, according to documents released by the FDA.
By Kurt R. Karst – It’s “Exclusivity Week”! First there was FDA’s Draft Guidance that, if finalized, would reinterpret the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity to a newly approved Fixed-Dose Combination (“FDC”) drug containing an NCE and a previously approved drug. That announcement was […]
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