FDA Catches Indian Drugmaker Destroying Crucial Inspection Papers
The documents were needed to verify testing and manufacturing practices at Granules, a company in Telangana, India, that supplies generic medications to the U.S., officials say. More pharmaceutical news is on migraine meds, HIV supplies, inhalers, and more.
Stat:
FDA: Indian Generic Drug Manufacturer Tossed Truckloads Of Key Documents
Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration. Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India. And when confronted by the FDA inspectors, the plant management acknowledged the papers should not have been destroyed. (Silverman, 9/19)
The New York Times:
Research That Led to Obesity Drugs Wins Major Medical Prize
The Lasker Awards, a prestigious set of prizes given for advances in medicine and public health research, were given on Thursday to scientists whose research helped lead to the discovery of a new class of obesity drugs, infectious disease specialists who worked on the drivers of H.I.V. infection and how to stop it, and a scientist who discovered a way the body protects itself from infectious diseases and cancer. The Laskers are highly regarded in the fields of biomedicine and are sometimes seen as foretelling recipients of the Nobel Prizes in the sciences. (Kolata and Nolen, 9/19)
FiercePharma:
New Migraine Drugs Less Effective Than Previous Generation Of Triptan Meds: BMJ Study
A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines. What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis. (Dunleavy, 9/19)
FiercePharma:
Theratechnologies' HIV Med May Run Short Due To Contractor Issue
Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short. Egrifta SV—approved to reduce excess abdominal fat in HIV patients with lipodystrophy—is at risk of facing a “temporary supply disruption” in early 2025, Theratechnologies warned in a release. (Kansteiner, 9/18)
CBS News:
Propellants In Regularly Prescribed Inhalers Are Accelerating Global Warming
New reports reveal the most commonly prescribed inhaler in the U.S. may actually be contributing to climate change. While these inhalers are critically important to saving lives and making it easier to breathe, a Stanford-led study is showing that there are easier, less polluting options. (Goodrich and McCrea, 9/19)
Stat:
Should Biogen, Gilead Sciences, GSK Disclose Patent Mistakes?
A group of lawmakers wants the U.S. Patent & Trademark Office and drug companies to change their approach toward handling mistakes in disclosing patent terms, because the errors can be exploited in ways that thwart competition and, ultimately, raise the cost of medicines. (Silverman, 9/19)
