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Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More
In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory Committee. Read More
Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for documentation to present to reluctant brand-name owners. Read More
“Clinical data to date indicate this investigational approach provides benefits in multiple tissues evaluated, including the eyes, skin, gastrointestinal mucosa and the neurocognitive system,” the company said. Read More
In a win for Amyndas Pharmaceuticals, the U.S. District Court in Massachusetts has overturned a lower court ruling that had dismissed the company’s complaint of misappropriation of trade secret agreements by Zealand US, allowing Amyndas to continue its legal battle. Read More
At least 88 additional lawsuits have been filed in Delaware against GSK and former Zantac (ranitidine) owners Pfizer, Boehringer Ingelheim and Sanofi, alleging the heartburn drug increases users’ risk of cancer. Read More
In addition to being interchangeable with their reference products, biosimilars approved in the EU are interchangeable with an equivalent biosimilar, the European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) said in a joint statement. Read More
Resolving allegations that it violated the False Claims Act, generic drugmaker Akorn has entered into a settlement to pay $7.9 million for causing Medicare to be billed for three over-the-counter (OTC) drugs that were no longer eligible for Medicare coverage. Read More