GSK Is Now Favorite to Acquire Pfizer's Consumer Health Business
Now that Reckitt Benckiser has walked away from a deal, GlaxoSmithKline is now the favorite to acquire Pfizer's consumer health business. Source: BioSpace
Array BioPharma Touts Phase III Results for Melanoma Therapy
Array BioPharma Inc. released detailed results for its late-stage combination treatment for metastatic melanoma. Source: BioSpace
Arena Pharma Raising $352 Million Following Positive Phase II Data
Arena Pharmaceuticals is hoping to raise $352 million from a stock offering just days after releasing positive top-line results from its Phase II trial of etrasimod in ulcerative colitis. Source:…
Labocont Draws Warning Letter for GMP Violations
The FDA warned a drugmaker in the Dominican Republic for significant good manufacturing practice violations including maintaining incomplete test data and faulty analytical methods. Source: Drug Industry Daily
Judge Partially Dismisses FTC Complaint Alleging Shire Used Fraudulent Petitions to Stifle Generics
A federal judge granted Shire’s motion to dismiss a Federal Trade Commission action against its citizen petitions relating to potential generic competitors, saying the FTC had not met a prerequisite…
Industry Group Sues HHS for Applying Medicaid Rebate Rule to Radiopharmaceutical Drugs
The Council on Radionuclides and Radiopharmaceuticals sued HHS arguing it improperly interpreted the 2016 Medicaid rebate program final rule by applying it to radiopharmaceutical products. Source: Drug Industry Daily
Gottlieb Testifies at E&C Committee Hearing on Initiatives to Fight Opioid Crisis
FDA Commissioner Scott Gottlieb highlighted the need to improve international mail facility operations and market conversion to opioids with abuse deterrents Wednesday at a House Energy and Commerce Committee subcommittee…
FDA Releases Final Guidance on Chemical Drug Starting Materials
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should…
State Oversight of Compounders Improved, But Some lack Resources
More U.S. states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the…
EMA Issues Guidance on Biomarkers, Criteria for Alzheimer’s Medicines
The EMA’s Committee for Medicinal Products for Human Use adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and…
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