Rep. Rosa DeLauro's recent letter to the FDA criticizing expedited approval pathways designed to accelerate the commercialization of innovative treatments does not capture the role of FDA's expedited approval programs in speeding therapies to patients suffering from unmet medical needs and faced with few or no medical alternatives.
While the meningitis B outbreak has died down, the debate it stirred up continues. This week researchers at the Manhattan Institute weighed in with their opinion: If a vaccine is good enough for Europe, it is good enough for the U.S..
Last week research firm GlobalData tipped the hepatitis B vaccine market to top $1 billion by 2022, with sales of Sanofi's Hexyon driving the sector's modest growth. Dynavax hopes to claim a slice of the market too, but its hepatitis B vaccine received another blow this week.
In its second trip through the FDA, Chelsea Therapeutics' antidizziness drug came out a winner, securing approval to fight faintness in patients with a rare disorder, but not without a daunting label and some strings attached.
Johnson & Johnson's Ethicon division won big in an ongoing suit regarding its vaginal mesh implants: After one week of testimony, a federal district judge in Charleston, WV, ruled that the company's pelvic mesh product did not cause injury.
Durect suffered a regulatory setback with the FDA rejection of its Posidur treatment for postoperative pain.
FDA Commissioner Margaret Hamburg returned from her trip to India talking up cooperation and collaboration between regulators there and the FDA. Not all regulators there, however, sounded as enthusiastic as she did.
Amgen has been issued an FDA warning letter for problems the agency says it found at its plant in Thousands Oaks, CA, which makes prefilled syringes and related devices used for its osteoporosis drug Prolia, and for Enbrel, the autoimmune disease treatment it shares with Pfizer.
FDA Commissioner Margaret Hamburg returned from her weeklong trip hobnobbing with Indian health regulators and pharma execs with an agreement from health officials there to work more closely with her agency. But India's top drug regulator sounded a little less enthusiastic than others about meeting all of the FDA's high expectations.
Global fallout from the Poly Implant Prothèse breast implant scandal continues, as the Welsh government refused to pay £1.2 million to replace faulty implants in women.