FDA Warns Fusion IV Over Labeling, Compounding Issues
The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section…
U.S. Appellate Judge Sides With Broad Institute in CRISPR Patent Case
In the latest tussle over lucrative patents covering the revolutionary gene-editing technology CRISPR-Cas9, an appeals judge for the U.S. Court of Appeals for the Federal Circuit said she would likely…
Sanofi, Regeneron to Cut Cholesterol Drug Price in Exchange for Inclusion on Express Script Plan
In what Regeneron CEO Len Schleifer called a “paradigm-shifting agreement,” Sanofi and Regeneron sealed a deal with the pharmacy benefit manager Express Scripts cutting the price of their cholesterol drug…
FDA Advisory Committee Signs Off on Risk-Benefit Profile of SIGA’s Smallpox NDA
In a 17-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee voted that the data show a favorable risk-benefit profile for TPOXX (tecovirimat) for its proposed indication for treating smallpox caused by…
Judge Rules Biogen Must Face Federal Portion of FCA Complaint
A Massachusetts judge ruled that Biogen must face a False Claims Act lawsuit brought by former employees alleging the company paid healthcare providers kickbacks to prescribe Biogen’s multiple sclerosis products,…
EMA Issues Q&A on Health-Based Exposure Limits and Prevention of Cross-Contamination
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: Drug Industry Daily
FDA Ad and Promo Enforcement Targets Presentation of Risk Info, Pre-Approval Promotions
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to…
U.S. Trade Rep Places Canada on Priority Watch List Over Drug Policies
In a move applauded by domestic drug groups, the U.S. Trade Representative added Canada to its priority watch list of countries with lax intellectual property protections or market access barriers…
U.S. Pharmacopeia Drops Biologics Naming Proposal
Citing concerns among stakeholders including the FDA, the U.S. Pharmacopeia decided not to move forward with proposed revisions to its nomenclature for biologics. Source: Drug Industry Daily
EMA’s CHMP Recommends Three Drugs at April Meeting
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended three medicines for approval and eight extensions at its April 23-26 meeting. Source: Drug Industry Daily
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