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Good morning. The climate right here in Chicago has been tremendous unstable. We’ve had thunderstorms the previous couple of days, and final evening I heard for the primary time a tornado warning. Really an ominous begin to the week!
With that, let’s get into the biotech information of the day.
Vertex desires U.S. permission to pay for fertility companies for Casgevy sufferers
Vertex, one of many corporations behind the gene remedy Casgevy, is suing the HHS Workplace of the Inspector Common, aiming to get clearance to pay for fertility companies for sufferers receiving the remedy.
To take Casgevy, sickle cell sufferers should bear chemotherapy to take away bone marrow cells, a course of that may trigger infertility. However many insurers, together with Medicaid, don’t cowl fertility preservation companies like freezing sperm or eggs within the context of sickle cell therapy.
Vertex has developed a program that provides monetary help for these companies, and it has sought to get assurance from the HHG OIG that this program doesn’t violate federal anti-kickback legal guidelines. The OIG has indicated verbally that it will not clear this system, and has missed a deadline for writing an official dedication, main Vertex to file this lawsuit.
Learn extra from my colleague Megan Molteni.
Trump’s choose for VP has a historical past of investing in drug corporations
Yesterday, Donald Trump introduced that he’s chosen Ohio Sen. J.D. Vance as his working mate. My colleagues Rachel Cohrs Zhang and Sarah Owermohle pored by way of Vance’s monetary disclosures to discover a historical past of investments in well being care corporations, providing a window into how he could view the biopharma business.
Vance’s largest investments are in AmplifyBio and Kriya Therapeutics, within the vary of $50,000 to $100,000, in line with his 2022 monetary disclosures. AmplifyBio is a contract analysis group that helps drugmakers examine and manufacture new medicines, whereas Kriya is growing gene therapies to deal with circumstances together with eye illnesses, diabetes, and epilepsy.
He additionally has smaller holdings within the vary of $1,000 to $15,000 in a broad vary of corporations concerned with pharmaceutical growth and medical gadgets.
Moreover, Vance has some supporters within the business. Former Celgene chairman Bob Hugin, who confronted criticism for value hikes on a most cancers drug throughout his failed Senate bid, donated $50,000 to a super PAC supporting Vance in 2022, in line with the marketing campaign finance monitoring website OpenSecrets.
Learn extra on Vance’s investments and his historical past on well being care insurance policies.
Biotech shares rebound as inflation cools
After plummeting earlier this yr, biotech shares have rapidly rebounded. The XBI has risen 22% since its low in April, and it’s up 11% year-to-date.
Roche appears to be like to have a aggressive GLP-1 drug
In an summary for a European diabetes conferences, Roche supplied some new information on an early-stage weight problems drug that it received from its acquisition of Carmot Therapeutics.
Roche had earlier reported that CT-388, which targets GLP-1 and GIP receptors, led to 18.8% weight reduction at 24 weeks in a placebo-controlled Part 1 trial. The brand new information recommend that weight reduction on the very best dose didn’t but attain a plateau on the finish of the trial, making it look to be a aggressive candidate, Jefferies analysts stated. (Word that Lilly’s Zepbound, which additionally targets GLP-1 and GIP, led to 21% weight reduction in a 72-week Phase 3 trial.)
The Jefferies analysts famous, although, there are nonetheless questions on how a lot industrial success might truly be achieved with this molecule, which they anticipate to launch in 2029. By then, Roche should be behind Novo and Lilly, that are each already finding out next-generation candidates in late-stage research.
Extra reads
- Revolution Medicines companies up Part 3 trial plans with newest most cancers drug information, BioPharma Dive
- EMA warns sufferers to inform docs about GLP-1 utilization earlier than surgical procedure, Endpoints
- At an Iowa county honest, a treasured custom carries on regardless of chook flu anxiousness within the dairy barn, STAT
