A good Thursday to you all, with Andrew Joseph here in London filling in for Mr. Pharmalot. A busy August continues, but we hope those of you lucky enough to sneak in a break are able to enjoy it. For those soldiering on, the tidbits will be here.…
Cancer vaccine experts are worried that if the Trump administration takes a hostile posture towards mRNA broadly as a technology, other applications like cancer therapy may eventually be hindered as well, STAT reports. Their concerns come after Health Secretary Robert F. Kennedy Jr. halted support for mRNA vaccines for infectious diseases, though the Biomedical Advanced Research and Development Authority grant cancellations didn’t appear to extend to oncology research or development. A potential concern is that the Food and Drug Administration, which is under Kennedy’s purview, may now be biased against new mRNA-based therapeutics. STAT also tells us that developers of mRNA therapeutics are similarly grappling with what the funding halt will mean for them.
An investigational obesity pill from Eli Lilly led to less weight loss in a late-stage trial than the reductions seen with injectable treatments on the market, results that weaken its competitiveness as one of Lilly’s most anticipated candidates, STAT shares. After 72 weeks, patients taking the highest dose of the therapy, called orforglipron, experienced 11.2% weight loss, while the drugs that are currently prescribed, Novo Nordisk’s Wegovy and Lilly’s Zepbound, showed 15% and 21% weight loss in their respective trials. While the new data could be a blow to Lilly, having orforglipron on the market could significantly improve access globally.
Meanwhile, Lilly reported earnings, raising its full-year profit and sales forecast, Reuters reports. The company is betting on surging demand for its blockbuster weight loss drug Zepbound, as it targets new markets and looks to grab more share from Novo’s Wegovy. Lilly said its share of the U.S. market for incretins, the class of drugs to which diabetes drug Mounjaro and Zepbound belong, increased to 57% during the quarter.
Novartis has made a takeover approach for rare disease-focused biotech Avidity Biosciences, as pharma companies continue to hunt for deals to offset looming patent cliffs, the Financial Times says, citing people familiar with the matter. San Diego-based Avidity has three medicines in clinical trials, which could be approved as early as 2027, that treat different forms of muscular dystrophy. Novartis is facing a significant patent cliff for some of its top-selling drugs, including its heart failure drug Entresto in the U.S. this year.
Jazz Pharmaceuticals has become the first drugmaker to get U.S. approval for a treatment for diffuse midline glioma with H3 K27M mutations, a rare brain cancer mainly affecting young people, Pharmaphorum brings us. The Ireland-domiciled company won accelerated approval from the FDA for oral DRD2 antagonist Modeyso (dordaviprone), which was acquired as part of its $935 million takeover of Chimerix earlier this year. The drug can be used to treat patients aged 1 or older whose cancer has progressed after prior therapy.
Exact Sciences announced that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome, STAT shares. Exact is paying Freenome $75 million for exclusive U.S. rights to current and future versions of the Bay Area company’s test, which is currently under FDA review. The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test. Exact had been developing its own test, but said this week that additional testing showed that the liquid biopsy test wasn’t accurate enough to win Medicare reimbursement.
U.S. regulators have lifted a pause on the use of Valneva’s chikungunya vaccine Ixchiq in older individuals, following a similar move from European officials, FirstWord Pharma says. The French vaccine maker said that the FDA had also okayed a labelling change reflecting safety concerns that emerged during clinical deployment. The revised prescribing information in the U.S. now carries updated warnings specifically addressing the potential risk of adverse events in individuals aged 65 and above with one or more chronic comorbidities.
Sarepta Therapeutics, which has come under regulatory pressure over its gene therapy for Duchenne muscular dystrophy, hired a Trump-connected lobbying firm after the death of a teenage boy treated with the drug, STAT tells us, citing lobbying disclosure reports. Michael Best Strategies began lobbying for Sarepta on June 10, and Sarepta had paid the firm $40,000 by the end of the month to lobby on “rare disease therapeutic development and access.” Among the lobbyists listed is Ninio Fetalvo, who worked in the White House and at the Centers for Medicare and Medicaid Services during the first Trump administration.
The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation, MedTech Dive reports. The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024. The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
