A great Thursday to you all, with Andrew Joseph right here in London filling in for Mr. Pharmalot. A busy August continues, however we hope these of you fortunate sufficient to sneak in a break are capable of take pleasure in it. For these soldiering on, the tidbits will probably be right here.…
Most cancers vaccine consultants are nervous that if the Trump administration takes a hostile posture in direction of mRNA broadly as a know-how, different purposes like most cancers remedy could ultimately be hindered as effectively, STAT reviews. Their considerations come after Well being Secretary Robert F. Kennedy Jr. halted assist for mRNA vaccines for infectious illnesses, although the Biomedical Superior Analysis and Improvement Authority grant cancellations didn’t seem to increase to oncology analysis or growth. A possible concern is that the Meals and Drug Administration, which is beneath Kennedy’s purview, could now be biased towards new mRNA-based therapeutics. STAT additionally tells us that builders of mRNA therapeutics are equally grappling with what the funding halt will imply for them.
An investigational weight problems capsule from Eli Lilly led to much less weight reduction in a late-stage trial than the reductions seen with injectable therapies in the marketplace, outcomes that weaken its competitiveness as one among Lilly’s most anticipated candidates, STAT shares. After 72 weeks, sufferers taking the best dose of the remedy, known as orforglipron, skilled 11.2% weight reduction, whereas the medication which are at present prescribed, Novo Nordisk’s Wegovy and Lilly’s Zepbound, confirmed 15% and 21% weight reduction of their respective trials. Whereas the brand new information might be a blow to Lilly, having orforglipron in the marketplace might considerably enhance entry globally.
In the meantime, Lilly reported earnings, elevating its full-year revenue and gross sales forecast, Reuters reviews. The corporate is betting on surging demand for its blockbuster weight reduction drug Zepbound, because it targets new markets and appears to seize extra share from Novo’s Wegovy. Lilly mentioned its share of the U.S. marketplace for incretins, the category of medication to which diabetes drug Mounjaro and Zepbound belong, elevated to 57% in the course of the quarter.
Novartis has made a takeover method for uncommon disease-focused biotech Avidity Biosciences, as pharma firms proceed to hunt for offers to offset looming patent cliffs, the Monetary Instances says, citing individuals accustomed to the matter. San Diego-based Avidity has three medicines in scientific trials, which might be accredited as early as 2027, that deal with totally different types of muscular dystrophy. Novartis is going through a major patent cliff for a few of its top-selling medication, together with its coronary heart failure drug Entresto within the U.S. this yr.
Jazz Prescription drugs has turn out to be the primary drugmaker to get U.S. approval for a remedy for diffuse midline glioma with H3 K27M mutations, a uncommon mind most cancers primarily affecting younger individuals, Pharmaphorum brings us. The Eire-domiciled firm gained accelerated approval from the FDA for oral DRD2 antagonist Modeyso (dordaviprone), which was acquired as a part of its $935 million takeover of Chimerix earlier this yr. The drug can be utilized to deal with sufferers aged 1 or older whose most cancers has progressed after prior remedy.
Precise Sciences introduced that it acquired the rights to a blood-based colon most cancers screening check from rival agency Freenome, STAT shares. Precise is paying Freenome $75 million for unique U.S. rights to present and future variations of the Bay Space firm’s check, which is at present beneath FDA overview. The deal ratchets up Precise’s intense competitors with Guardant Well being, which acquired FDA approval final yr for its personal blood-based colon most cancers check. Precise had been creating its personal check, however mentioned this week that further testing confirmed that the liquid biopsy check wasn’t correct sufficient to win Medicare reimbursement.
U.S. regulators have lifted a pause on using Valneva’s chikungunya vaccine Ixchiq in older people, following an identical transfer from European officers, FirstWord Pharma says. The French vaccine maker mentioned that the FDA had additionally okayed a labelling change reflecting security considerations that emerged throughout scientific deployment. The revised prescribing info within the U.S. now carries up to date warnings particularly addressing the potential danger of hostile occasions in people aged 65 and above with a number of power comorbidities.
Sarepta Therapeutics, which has come beneath regulatory stress over its gene remedy for Duchenne muscular dystrophy, employed a Trump-connected lobbying agency after the dying of a teenage boy handled with the drug, STAT tells us, citing lobbying disclosure reviews. Michael Greatest Methods started lobbying for Sarepta on June 10, and Sarepta had paid the agency $40,000 by the tip of the month to foyer on “uncommon illness therapeutic growth and entry.” Among the many lobbyists listed is Ninio Fetalvo, who labored within the White Home and on the Facilities for Medicare and Medicaid Providers in the course of the first Trump administration.
The Federal Commerce Fee has moved to dam Edwards Lifesciences’ deliberate acquisition of JenaValve Expertise, citing considerations that the deal threatens to cut back competitors available in the market for units to deal with aortic regurgitation, MedTech Dive reviews. The company alleged that over two days in July 2024, Edwards signed agreements to accumulate each JenaValve and JC Medical, the 2 main firms competing to deliver transcatheter aortic valve substitute units to market to deal with the possibly deadly coronary heart situation. Edwards closed the acquisition of JC Medical in August 2024. The FTC mentioned Edwards’ proposed $945 million acquisition of JenaValve would mix the one two firms conducting U.S. scientific trials for a TAVR aortic regurgitation, or TAVR-AR, machine.
