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Hot tip, all: Don’t jump off 6-foot playground equipment. You will scare your mother, and wind up in a cast. The need-to-know this morning Kodiak Sciences said Zenkuda, its experimental vision-sparing treatment for a common cause of age-related blindness, achieved statistical equivalence to Eylea , a standard therapy, in a Phase 3 clinical trial.
Merck said it paid $400 million upfront to China’s SciBrunch Therapeutics , for global license rights to a preclinical cancer drug that targets tumors with KRAS G12D mutations. The deal is valued at $2.13 billion if all future milestones are achieved. Novo turns GLP-1 drugs into consumer products Novo Nordisk is increasingly marketing its GLP-1 drugs less as treatments for a chronic disease and more as consumer products for people who simply want to lose weight, STAT’s Elaine Chen writes.
It’s a shift that comes as insurance coverage for these obesity medicines remains limited. The company now calls Wegovy a “weight loss” drug rather than an obesity or weight-management treatment. It’s embracing this wave of “customer obsession,” and has leaned heavily into direct-to-consumer sales — which already account for 90% of prescriptions for its new Wegovy pill.
Some clinicians worry the pivot undermines years of work to establish obesity as a chronic disease deserving insurance coverage and could deepen inequities, since patients paying cash can still spend as much as $400 to $450 a month. Novo says its view of obesity as a serious chronic disease hasn’t changed and that it continues to push for broader coverage. Read more.
AbbVie wins FDA nod for Parkinson’s pill The FDA has approved AbbVie’s once-daily Parkinson’s pill, tavapadon, to be sold as Juvmo. The drug is part of its $8.7 billion acquisition of Cerevel Therapeutics . The dopamine receptor agonist was approved for adults with Parkinson’s based on a late-stage study that showed the drug helped improve symptoms, Reuters writes.
AbbVie has said it sees more than $5 billion in combined sales from its Parkinson’s portfolio, though Citi analysts have cautioned that Juvmo’s uptake could be gradual as Medicare coverage negotiations play out. AI is eroding barriers to biological weapons AI is making it easier for sophisticated actors to develop biological weapons, and existing safeguards aren’t keeping pace, former White House Covid response coordinator Ashish Jha argues in new First Opinion. Anthropic recently blocked five users whose work could support bioweapons development, illustrating a fundamental problem, he notes: The same models that can help scientists develop vaccines and drugs can help other folks bridge any gaps in expertise they may have — and engineer dangerous pathogens.
And another barrier is weakening. Researchers recently found that 36 of 38 DNA synthesis companies supplied fragments that could allow a skilled scientist to reconstruct the 1918 flu virus. Jha argues that slowing frontier AI development might buy time, but the more durable answer is layered biodefense, including testing models for dangerous capabilities, overseeing access to advanced biological models, strengthening DNA-synthesis screening, and investing in systems to detect biological threats.
“We can’t depend on every lab, every country, and every open-source developer getting biosecurity right. They won’t,” Jha writes. “Over time, that means the development and potential use of biological weapons becomes more likely.
Defenses against this threat take years to build. We don’t have years to spare.” Read more. Trump claws back nearly $1 billion in spending President Trump is canceling nearly $1 billion in congressionally approved spending across several agencies — largely targeting HHS programs for refugees and unaccompanied minors, as well as diversity-focused initiatives.
The administration is using a rarely invoked maneuver known as a “pocket rescission,” announcing the cuts just days before the fiscal year ends. This basically leaves Congress without its usual 45-day window to consider them. The Government Accountability Office has said pocket rescissions are illegal, and Republican Senate Appropriations Chair Susan Collins called the move a usurpation of Congress’ spending authority.
The Trump administration claims the maneuver is legal. Trump used the same tactic last year to block $4.9 billion in foreign aid, though this time the administration is targeting domestic programs. Read more.
Roche licenses flu drug for pandemic preparedness Roche is licensing its influenza drug Xofluza to 11 generic manufacturers in an effort to expand access in lower-income countries — and prepare for the possibility that flu sparks the next pandemic. Under deals brokered by the U.N.-backed Medicines Patent Pool, STAT’s Ed Silverman writes, the manufacturers will be able to develop and supply generic versions of Xofluza in 129 countries. The agreements will be royalty-free in low-income countries, with royalties of 5% and 10% of net sales in lower- and upper-middle-income countries, respectively.
The move comes as global health officials push countries to build drug and vaccine manufacturing capacity before the next health emergency, after poorer nations struggled to secure supplies during Covid-19. “Strengthening regional manufacturing and building diverse supply and access pathways now can help ensure that low- and middle-income countries are not left waiting for essential tools when the next health emergency occurs,” said Aggrey Aluso, director for Africa of Resilience Action Network International, a civil society group, in a statement. “The progress on [Xofluza] is a practical example of the kind of preparedness we need.” Read more.
More reads FDA approves Mirum’s drug for ultra-rare soft tissue disease, Endpoints Merck, Daiichi pull US application for second partnered cancer therapy, Reuters Merck, Eisai’s Welireg-Lenvima combo lands FDA nod to jump the kidney cancer queue, Fierce Pharma
Source: statnews.com
