After nearly 20 years in development, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will get its day before the FDA’s Antimicrobial Drugs Advisory Committee Oct. 7. During the course of its development by various companies, the drug’s indication has morphed from a prophylaxis to a treatment of resistant or refractory cytomegalovirus infection in both solid organ and hematopoietic stem cell transplant recipients.
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.
As expected, Mirum Pharmaceuticals Inc. won FDA clearance for Livmarli (maralixibat), a minimally absorbed ileal bile acid transporter inhibitor, for cholestatic pruritus in patients with the rare liver disease Alagille syndrome, 1 year of age and older.
The FDA unveiled a draft guidance addressing the responsibilities of clinical investigators for safety reporting for investigational drugs and devices, a novel attempt to combine the disparate adverse event reporting timelines for investigational drugs and devices.
With the FDA approval of Abbvie Inc.’s Qulipta (atogepant) to prevent episodic migraine in adults, the oral calcitonin gene-related peptide (CGRP) receptor antagonist became the first specifically developed for preventing migraine.
As part of its real-world evidence (RWE) program, the U.S. FDA is issuing a draft guidance on using electronic health records and medical claims data in clinical trials to support a drug’s safety and effectiveness.
Thanks to a drop in the cost of conducting U.S. FDA reviews, it’s getting even cheaper to use a priority review voucher (PRV) to shave four months off the agency’s standard 10-month drug review.
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
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