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NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More
FDA enforcement of drug companies’ use of off-label promotion is being made more difficult by Amarin’s successful lawsuit against the agency and by a government website, ClinicalTrials.gov, a law professor says. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
Before wasting time and money on a clinical trial, sponsors should determine whether additional preclinical studies are needed to rule out a drug candidate’s potential for endocrine-related adverse effects, the FDA says. Read More
The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
GlaxoSmithKline is recalling more than 427,000 tubes of mupirocin calcium 2% creams and ointments in various sizes due to penicillin cross contamination and the presence of particulates. Read More
The FDA has granted breakthrough therapy designation to Roche’s investigational ACE910 for the prophylactic treatment of patients 12 years and older with hemophilia A with factor VIII inhibitors. Read More
The FDA has delayed by three months its decision on Alexion Pharmaceuticals‘s metabolic disorder drug Kanuma to review new chemical manufacturing and controls information. Read More
The European Commission has approved Novartis’ Farydak as the first histone deacetylase inhibitor for treatment of multiple myeloma available in the EU. Read More
In observance of the Labor Day holiday, Drug Industry Daily will not be published Monday, Sept. 7. The next issue will be published Tuesday, Sept. 8. Read More