Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
Eli Lilly’s best play for Foundayo is to bring it overseas, a more price-sensitive market where the pharma can more readily outcompete Novo Nordisk “given the high margins of a small-molecule therapy,” Truist analyst Srikripa Devarakonda told BioSpace.
Roche, through its subsidiary Genentech, will gain access to the investigational asset HM17321, which is designed to not only elicit weight loss but also improve lean mass.
The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
Not much is known about Boehringer Ingelheim’s drug candidate, dubbed BI 3031185, though the asset has completed at least two other Phase 1 studies this year.
FDA
Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.
Despite coming away with an early victory over Eli Lilly in the oral obesity face-off, analysts don’t expect Novo Nordisk’s lead to last for very long.
The discontinuation of the uveitis study adds to Regeneron’s series of clinical setbacks, including the Phase 3 failures of the Dupixent follow-up itepekimab and an investigational combo regimen for melanoma.
With a Phase 3 trial showing a reduction of serious and severe hypoglycemic episodes in patients who have undergone weight loss surgery, Amylyx Pharmaceuticals plans to file for approval this year. If granted market entry, avexitide could hit peak sales of $1.7 billion worldwide, analysts estimate.
AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma.
Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month, showed “impressive” stabilization, analysts say.
Johnson & Johnson secured rights to prizlon-cel in 2023 for $245 million upfront. The asset in June last year showed a 100% response rate as a second-line option in a Phase 1b study for 10 patients with relapsed or refractory large B cell lymphoma.
The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter.
Sponsors of the pivotal study behind Amgen’s rare disease drug Tavneos saw unblinded findings for the drug and re-adjudicated data from nine patients to make the drug seem effective, according to European regulators.
The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts.