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A drug pricing watchdog was rebuffed Monday in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
The FDA and European Medicines Agency have accepted new drug applications for Boehringer Ingelheim’s Gilotrif as a treatment option for patients with advanced squamous cell lung cancer that has progressed after treatment with first-line chemotherapy. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
The FDA appears to have anticipated one issue drugmakers raised at a Monday public meeting on its quality metrics draft guidance — extending the comment period on the document until Nov. 27. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a Monday public meeting on the draft document. Read More
Novartis scored its second FDA approval for Promacta since acquiring the drug from GlaxoSmithKline in March, this time to treat children ages 1 to 5 with a rare blood disorder that causes low platelet counts. Read More
AstraZeneca and Peregrine Pharmaceuticals are collaborating on an early-phase clinical trial to evaluate the safety and efficacy of two novel investigational drugs in patients with a range of solid tumor types. Read More
Exelixis expects to submit an NDA by the end of this year for cabozantinib to treat advanced renal cell cancer, following the receipt of FDA breakthrough therapy designation for use in patients who have received one prior therapy. Read More