Roche’s Sabry retires; Duchenne drug fails confirmatory test
28 May 2024
Clinical ResultPhase 3Drug ApprovalExecutive Change
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!
Today, a brief rundown of news from Merck & Co. and biotechnology startup Cartography Biosciences, as well as updates from Roche, Novartis, Novo Nordisk and Nippon Shinyaku that you may have missed over the holiday weekend.
Merck & Co.’s drug Keytruda helped people with a hard-to-treat form of breast cancer live longer when used first as a neoadjuvant, or preoperative, therapy, and then as an adjuvant therapy. The study, called Keynote-522, compared Keytruda- and chemotherapy-based regimens to neoadjuvant chemo alone in early-stage “triple-negative” breast cancer that’s considered high risk. Merck, which won U.S. approval for the regimen in July 2021 based on earlier data, said Tuesday the improvement in survival was “statistically significant and clinically meaningful.” — Ned Pagliarulo
Cartography Biosciences will receive $20 million from Gilead Sciences in a research collaboration to discover drug targets for cancers of the breast and lungs. Cartography, which raised $57 million in a Series A venture financing two years ago, touts a pair of computational and genomics platforms that it says can map novel tumor-selective antigens. — Ned Pagliarulo
James Sabry, who has led pharma partnering for Roche, is retiring after fourteen years with the Swiss drugmaker, the company said Monday. He will be replaced by Boris Zaïtra, who will on July 1 become head of group business development, a new role that combines several dealmaking functions. Zaïtra will report to Roche CEO Thomas Schinecker as part of an enlarged executive committee. — Ned Pagliarulo
Preliminary results from a confirmatory clinical trial of Nippon Shinyaku’s Viltepso for Duchenne muscular dystrophy showed treatment didn’t lead to a meaningful benefit over a placebo. The study, which enrolled 77 boys with Duchenne who could still walk, measured the time it took participants to stand from lying down. After 48 weeks, both groups showed a “trend of increased velocity” from baseline, with no statistically significant difference between them. The study was meant to confirm Viltepso’s accelerated approval, which the Food and Drug Administration granted in 2020. Nippon Shinyaku said it is conducting further analyses of the results and working closely with regulators. — Ned Pagliarulo
Novartis on Monday announced positive Phase 3 results for two kidney disease drugs it’s developing. One, called atrasentan and acquired through a buyout of Chinook Therapeutics, significantly reduced protein in urine compared to a placebo among people with a rare condition known as IgA nephropathy. The other, an approved medicine Novartis sells as Fabhalta, also lowered proteinuria versus placebo in treating C3 glomerulopathy, an even less common disease. Proteinuria reduction is considered a surrogate marker of benefit in certain kidney conditions, and Novartis plans to submit both drugs for regulatory approvals in IgA nephropathy and C3 glomerulopathy, respectively. — Ned Pagliarulo
A panel of FDA advisers voted 7-4 against recommending approval of a weekly insulin injection from Novo Nordisk in people with Type 1 diabetes, according to Reuters. The shot, called insulin icodec, could offer a more convenient alternative than current daily insulin injections. But FDA staff flagged a higher rate of hypoglycemia in participants given Novo’s experimental drug in testing, compared to those who received a comparator treatment. The agency usually, though not always, follows its advisers’ recommendations. In Europe, regulators recently authorized insulin icodec for sale there. — Ned Pagliarulo
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