Nexgen Pharma Cited for GMP Violations
The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Source: Drug Industry Daily
CDER Denies Fourth United Therapeutics Petition on ANDAs Referencing Tyvaso
CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso…
Insurers Sue Pfizer Over Coverage for $400 Million Off-Label Marketing Settlement
Three insurers sued Pfizer to stay off the hook for a $400 million settlement reached by the drugmaker over off-label marketing, claiming the relevant policies had expired. Source: Drug Industry…
FDA Unveils Data Standards Strategy for FY 2018-2022
CDER and CBER issued a joint data standards strategy on Monday, detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data…
The Stunning Golden Parachutes of Juno's $9B Celgene Deal
Juno's Hans Bishop will take home $287M after Celgene acquired his company. Source: BioSpace
Boston's Intarcia Pink Slips 60 Employees, Terminates Two Late-Stage Trials
A tipster told BioSpace that the layoffs were initially announced by Intarcia CEO Kurt Graves on Jan. 31. Source: BioSpace
GSK, Reckitt are the Only Suitors for Pfizer's $20B Consumer Health Biz
Companies including Sanofi, J&J, Nestle have dropped out. Source: BioSpace
The 3 Small CRISPR Biotechs That Could Cure 10,000 Diseases
A look at three small biotech companies that appear to be leading the CRISPR race. Source: BioSpace
3 High-Risk Biotechs That Could Pop or Drop in 2018
A look at three biotech companies that face make-or-break catalysts this year. Source: BioSpace
Suitors Take Note as Bay Area's Nektar May Be Up for Sale
Nektar is reportedly exploring various strategic options, including a possible sale, partnerships or licensing agreements. Source: BioSpace