All posts tagged: pharmaceutical industry

An FDA Panel Just Endorsed These Unproven Peptides

An FDA Panel Just Endorsed These Unproven Peptides

Published by skeptic

Peptides are inching closer to the mainstream. A panel of experts on Thursday narrowly recommended that the Food and Drug Administration reclassify four popular peptides—including one endorsed by podcaster Joe Rogan—to allow certain pharmacies to legally dispense them. In an at-times emotionally charged meeting that lasted more than 11 hours, members of an FDA advisory committee heard data presentations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from health care practitioners, patients, pharmacies, and clinics. Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulks list, meaning compounding pharmacies can use them to create custom medications for patients. (The fourth peptide—MOTs-C—received a seven-to-five vote in favor, with two abstentions.) The advisory panel, which includes several members tied to peptide-related businesses and telehealth clinics, will consider three more peptides on Friday. Peptide therapies have been growing in popularity thanks to the endorsement of podcasters, wellness influencers, and Health and Human Services Secretary Robert F. Kennedy Jr., who has said he’s a …

The Great Peptide Cash Grab Has Begun

The Great Peptide Cash Grab Has Begun

Published by skeptic

Has anyone tried to sell you peptides yet? If not, they probably will soon. Once a niche interest among bodybuilders and biohackers, peptides are an increasingly popular class of substance hyped by both fringe influencers and the current US Secretary of Health and Human Services. Earlier this year, Robert F. Kennedy Jr. told the podcaster Joe Rogan that the government intended to loosen restrictions on peptide production. This week, it could finally happen: On July 23 and 24, the Food and Drug Administration will discuss whether to reclassify a group of peptides so that pharmacies can legally make custom mixes, a process known as compounding. The move would reverse a decision made in 2023 by the Biden Administration, which barred certain peptides from being compounded. Although career scientists at the agency have recommended against it, many industry insiders tell WIRED they believe the FDA will approve reclassification anyway, since the committee put together to do the assessment includes peptide boosters. Some players in the telehealth world are already operating under the assumption that the floodgates …

Trump signs order threatening up to 100% tariffs on pharmaceuticals

Trump signs order threatening up to 100% tariffs on pharmaceuticals

Published by Sam Flores

President Donald Trump signed an executive order Thursday that could slap long-threatened pharmaceutical tariffs of up to 100 percent on some patented drugs from companies that don’t reach deals with his administration in the coming months. Companies that have signed a “most favoured nation” pricing deal and are actively building facilities in the US to onshore production of patented pharmaceuticals and their ingredients will have a 0 percent tariff. For those that don’t have a pricing deal but are building such projects in the US, a 20 percent tariff will apply but will increase to 100 percent in four years. A senior administration official told reporters on a press call that companies still have months to negotiate before the 100 percent tariffs kick in – 120 days for bigger companies, and 180 days for everyone else. The official, speaking on condition of anonymity to preview the executive order before it was issued, did not identify any companies or drugs that were in jeopardy of getting hit with the increased tariffs but noted the administration had …

FDA Approves Eli Lilly’s GLP-1 Pill

FDA Approves Eli Lilly’s GLP-1 Pill

Published by skeptic

The US Food and Drug Administration on Wednesday approved a new obesity pill called Foundayo. Taken once daily, the pill is made by pharmaceutical company Eli Lilly, which also manufactures the popular weight-loss injection Zepbound. Foundayo is a type of medication known as a GLP-1, a category that includes rivals Ozempic and Wegovy. These drugs mimic a naturally occurring hormone in the body that regulates blood sugar, slows digestion, and signals a sense of fullness to the brain. It’s now the second GLP-1 pill for weight loss on the market. In December, Novo Nordisk received FDA approval for its pill form of Wegovy. The company’s original version of Wegovy is a weekly injectable. While the Wegovy pill must be taken on an empty stomach in the morning, Lilly says Foundayo can be taken any time of day without food or water restrictions. With injectable GLP-1 drugs in high demand, pharma companies have been racing to develop weight-loss pills, which could be preferable for some patients and could potentially expand the market for GLP-1s. Pills are …