More New Drugs and Faster Approvals
FDA drug approvals hit an 18-year high in 2014, bolstered by new biologic-based drugs and breakthrough therapies.

Ascension Health Bans Genentech Sales Reps After Losing Drug Discounts
A change in the supply chain for three important Genentech cancer medications elicits a strong reaction from one of the nation’s largest operators of hospitals.

Thermo Fisher Scientific Completes Acquisition of Life Technologies
Thermo Fisher Scientific outlines new business segments with acquisition of Life Technologies.

FDA Issues Warning Letter to GSK Biologicals
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA Updates Analytical Validation Guidance
FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market
FDA adds Ranbaxy’s Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location.

Merck Recalls Cholesterol Medicine Due to Packaging Defect
A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

FDA Releases Guidance on CMC Postapproval Changes
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

Merck Receives Accelerated Approval of the First FDA-Approved Anti-PD-1 Therapy
KEYTRUDA was approved for the treatment of unresectable or metastatic melanoma and disease progression.

Teva Announces New Organizational Structure and Acquisition of Labrys Biologics
Teva assigns new executive positions and acquires Labrys Biologics.

Report: Branded Biopharms Most Exposed to Biosimilar Competition
Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

Merck KGaA Acquires Sigma-Aldrich for $17 Billion
Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich.

USP Announces Revision Timeline, Effective Date for Elemental Impurities Limits and Procedures
USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.

FDA Accepts First Biosimilar Filing
Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.