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Friday, Sep 20 2024

Full Issue

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.

Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of 鈥渟crap materials鈥 from a facility that was being inspected last month by the Food and Drug Administration. Specifically, a 鈥渓arge number of torn pieces鈥 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 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)

A study from The BMJ聽indicates that the newest class of migraine drugs鈥攚hich includes Pfizer鈥檚 Nurtec, AbbVie鈥檚 Ubrelvy and Eli Lilly鈥檚 Reyvow鈥攊s 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)

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鈥攁pproved to reduce excess abdominal fat in HIV patients with lipodystrophy鈥攊s at risk of facing a 鈥渢emporary supply disruption鈥 in early 2025, Theratechnologies聽warned in a release. (Kansteiner, 9/18)

New reports reveal the most commonly prescribed inhaler in the U.S. may actually be contributing to climate change.聽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)

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)

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