The peptide compounding landscape shifted last week, and if you are interested or involved in the peptide industry, compounding pharmacies, telehealth, or the broader market for injectable wellness products, you’ll want to understand what happened—and perhaps more importantly, what hasn’t happened yet. FDA’s PCAC Meeting Announcement We …
The GLP-1 market is set to hit over $30 billion by 2030. Intellectual property litigation and FDA crackdowns have led to a boom in M&A and partnership activity. Long-term patient effects have yet to be fully realized. The future of GLP-1s is bright, but ownership, …
As any well-rounded consumer of television knows, one of the most ubiquitous tropes in sitcoms is the “will they-won’t they” dynamic. Take your pick: Ross and Rachel from Friends, Jim and Pam from The Office, or Mulder and Scully from The X-Files. It’s riveting and …
As many of our blog readers already know, direct-to-consumer (“DTC”) prescription drug promotion has been a regulatory flashpoint for years, and especially recently with FDA’s DTC crackdown (see our previous posts here, here, and here), but a new bipartisan push suggests the conversation may be …
In response to what FDA calls “inadequate responses to FDA 483 observations due to a lack or omission of relevant data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA …
The FDA has issued a notice announcing the opening of a public docket to solicit information and comments on its longstanding Scale-Up and Postapproval Changes (SUPAC) guidances for specific dosage forms. The request signals the Agency’s interest in reassessing these documents in light of evolving …
FDA has published its long awaited Final Rule Revising the National Drug Code Format and Drug Label Barcode Requirements which will expand the dwindling supply of FDA labeler codes and corresponding NDCs to what FDA states is a 900-year supply. As a reminder, NDCs are …
As regulatory frameworks for orphan medicinal products continue to evolve on both sides of the Atlantic, understanding the practical and strategic implications is increasingly important. On March 17th from 10:00 to 11:00 ET, Pinsent Masons and Hyman, Phelps & McNamara, P.C. are pleased to host a …
Two little mice fell in a bucket of cream. The first mouse quickly gave up and drowned. The second mouse, wouldn’t quit. He struggled so hard that eventually he churned that cream into butter and crawled out. Gentlemen, as of this moment, I am that …
While 3-year new clinical investigation exclusivity has never been the holy grail of exclusivities—we reserve that for 7-year orphan drug exclusivity or 5-year new chemical entity exclusivity (with the plus-5-year GAIN and plus-6-month pediatric exclusivity additions!) because of the different lengths and scopes—it plays an …
Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled …
If Part 1 of our Rare Disease Month series highlighted The Good, and Part 2 addressed The Bad, Part 3 turns to The Ugly. And by “Ugly,’ we mean something entirely different – members of Hyman, Phelps & McNamara will be well represented at Rare …
February is Rare Disease Month, an important time to celebrate successes in addressing the needs of our fellow 25 to 30 million Americans living with a rare disease, but also to renew our resolve in addressing the much larger remaining challenges – both new and …
February is Rare Disease Month, designated as such to raise awareness and to support the millions of individuals affected by rare diseases. It is also an extremely meaningful time for those of us at HPM who work regularly with sponsors to help get therapies to …
FDA is now accepting submissions to its PreCheck Pilot Program, which is the Agency’s latest initiative to increase domestic production of pharmaceuticals. The two-phase structure of the Program and its benefits to industry, which we previously detailed in connection with the Onshoring Manufacturing of Drugs …
