Clinical Research Mixer’s Curated Research Highlights
Caring beyond Prescriptions:
Regeneron hosts the world’s largest pre-college science and engineering competition. Awarding more than 9M to young winners, which included George D. Yancopoulos Innovator Award a $75,000 Award won by 16 year old Grace Sun (on the left) for her research in building an organic electrochemical transistor. The 2024 Regeneron Young Scientist Award was won by Michelle Wei (on the right).
We’ve Heard Rumblings:
Johnson and Johnson (J&J) acquired NM26, A Phase II bi-specific antibody for treatment of Atopic Dermatitis. J&J paid 1.25B to acquire Yellow Jersey Therapeutics, a spin off from Numab which will consist of all NM26 assets. Let’s hope this acquisition is as soothing as J&J’s Caladryl, a calamine lotion used for itchy skin.
An FDA twist that was not so sweet for Novo Nordisk. The company’s Icodec submission for weekly injections for type 1 diabetes was a dream for patients who regular poke themselves multiple times a day. However, the FDA’s independent experts voted against the weekly injections after reviewing the clinical data submitted, and found the risk of low blood sugar in patients with type 1 diabetes could lead to hypoglycemia.
We found out this month that Insmed’s ASPEN study, a Phase III trial in patients with Bronchiectasis, wasn’t just blowing hot air. The trial was a success! ASPEN achieved its primary Endpoint, reduction of pulmonary exacerbations by approx. 20% compared to placebo. Leaving investors breathing easy, as shares of Insmed more than doubled in pre-market trading.
To end May on a high note, my employer, Scout, has made an impressive press release. Sharing Scout has secured partnerships with 2 of the top 20 pharma companies for patient services! This announcement is the cherry on top, after announcing earlier in May that Scout won the MedTech Breakthrough Award for the second year in a row! It’s clear that Scout is not just a participant in the race for trial innovation, Scout is leading the pack!
The More You Know:
FDA has a program to issue priority review vouchers to companies. These vouchers are a special perk used as incentives to help promote treatments for diseases that lack effective therapies. Here’s the interesting part: A company can use this voucher to fast-track the FDA review of one of its treatments, which is a significant advantage. But there’s a twist, the company can also opt to sell the voucher to another company, potentially for a hefty price.
Pfizer is a recent recipient of the Priority Review Voucher. While Pfizer’s plan for the voucher is unknown. We do know these vouchers can bring top dollar if Pfizer decides to sell. Last year Sarepta made news by selling their voucher to a mystery buyer for an estimated 102M!
And finally, our
Hall of Shame for May 2024:
In the upcoming legal drama, “Patent Wars, the Junk in Your Trunk” we learn a slew of warning letters have been issued by the Federal Trade Commission (FTC). The FTC are calling out companies such as Novo Nordisk, AstraZeneca, GSK, and Teva for their “junk” patents. The FTC has sent 10 warning letters disputing over 300 patents alleging the “junk” patents are not related to the drugs themselves but are linked to a sneaky patent for drug/device combinations. Pharma companies have the right to defend their patents, doing so could put a 30-month delay or more on generic versions hitting the market!
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