U.S. President Donald Trump called on the pharmaceutical industry to boost U.S. production and lower prices, while also vowing to speed up approval times for new medicines and appoint a new U.S. Food and Drug Administration leader soon.
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OptiNose today announced the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application (NDA) for the investigational new product OPN-375 for the treatment of nasal polyposis in adults.
A bitter defeat in a U.S. patents case is the latest in a series of setbacks for Teva that has investors calling for major changes at the generic drugmaker.
At its annual financial report, Pfizer quietly indicated that it had canceled three pipeline projects from its programs.
Fourth-quarter 2016 revenue increased 7 percent, driven by volume growth from Trulicity and other new pharmaceutical products. Full-year 2016 revenue increased 6 percent to $21.2 billion.
Novartis broadened the indications for its Votubia drug with EU approval of its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex.
Mylan NV said U.S. antitrust authorities had launched an investigation into its EpiPen emergency allergy treatment.
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Cumberland Pharmaceuticals Inc. – a specialty pharmaceutical company focused on hospital acute care and gastroenterology – announced that the U.S. Court of Appeals for the Federal Circuit ruled in favor of Cumberland in a patent case associated with its Acetadote product.