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Gilead Submits NDA for Combo Drug That Treats All Genotypes of Hep C FDA AdComm Cancels Review of Repos’ Testosterone Replacement Candidate Pfizer and Allergan in Merger Talks Ultragenyx, Arcturus Partner to Develop mRNA Therapeutics to Rare Disease Targets
Pfizer Recruits GSK to Build Manufacturing Prototype Sanofi Recalls Auvi-Q Due to Potentially Inaccurate Dosage Delivery Read More
In a draft guidance Thursday, the FDA cautions that liposome drug products may respond to chemistry, manufacturing and control (CMC) changes with greater unpredictability than more conventional formulations. Read More
The FDA is once again giving retail and health system pharmacies that act as dispensers four months to ensure that product tracing information required by track-and-trace regulations is captured and maintained. Read More
The FTC is telling the FDA that its proposal to add four-letter suffixes to nonproprietary names for biosimilars and other biological products could be bad for business. Read More
Warner Chilcott has agreed to pay $125 million to settle charges that it paid kickbacks to physicians to induce them to prescribe seven drugs, and the company’s former president was charged with conspiring to pay the kickbacks, the Department of Justice announced Thursday. Read More
FDA Expands Approval for BMS’ Yervoy to Treat Melanoma FDA Panel Recommends Adding One Substance to the Compounding Bulk Ingredients List CDER Outlines Process for Gathering Network of Experts UK Early Access to Medicine Report Highlights Strategies to Spark Drug Innovation Read More
The European Medicines Agency’s EudraVigilance system for monitoring adverse events is undergoing an overhaul to comply with new postmarketing clinical trials legislation, and regulators are readying drugmakers and national authorities for a new plan. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
Drugmakers are telling the FDA that its proposed biosimilars naming is not necessary, but if four-letter suffixes are needed in the nonproprietary naming of biosimiliars and other biologic products, then make sure those letters are memorable. Read More