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The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More
Former InterMune CEO W. Scott Harkonen’s crusade to challenge his felony conviction in a closely watched free speech case collapsed after the Supreme Court declined to hear his appeal. Read More
French authorities on Thursday fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
The FDA will allow Ariad Pharmaceuticals to resume U.S. sales of its leukemia drug Iclusig, but the drugmaker must now implement a host of stringent safety measures designed to address the drug’s risk of blood clots. Read More
Amarin has received an FDA untitled letter for omitting risk information in a print promotion for its fish oil drug Vascepa, adding to a pileup of setbacks for the product. Read More
China cleared the way for the FDA to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Eli Lilly and Acrux on Nov. 12 filed suit against Actavis to prevent the generic drugmaker from commercializing a generic version of the testosterone topical solution Axiron. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a recent SEC filing. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More