Incyte Who? Why This Biotech Would Give Gilead a Bang for Its Buck
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks.jpg" NAME"Incyte Who? Why This Biotech Would Give Gilead a Bang for Its Buck" ALT"Incyte Who? Why This Biotech Would Give Gilead a Bang for Its Buck"January 26, 2017By…
Boston's InSpire MD Eyes $24.8 Million Series C Round
Life Sciences Jobs ... Source: BioSpace
Endo International Eliminates 90 Jobs in Restructuring
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-endo-international.jpg" NAME"Endo International Eliminates 90 Jobs in Restructuring" ALT"Endo International Eliminates 90 Jobs in Restructuring"January 26, 2017By Alex Keown, BioSpace.com Breaking News Staff<BR... Source: BioSpace
FDA Rejects Biosimilar Naming Petitions from GPhA, Sandoz; Approves J&J’s
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on…
Valeant Files Patent Lawsuit Over Zydus’ Cardizem Generic
Valeant has sued Zydus over the alleged infringement of a patent covering the company’s extended-release hypertension drug, Cardizem LA. Source: Drug Industry Daily
FDA: Porton Failed to Follow Contamination Procedures, Notify Agency of Product Changes
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Source:…
Mezzion Sues Dr. Reddy’s for Concealing GMP Deficiencies That Resulted in An NDA Rejection
Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an…
Shredded Documents and Dirty Equipment Net Hetero Labs a Form 483
Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s…
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