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Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say.
Eli Lilly and the Haisco Pharmaceutical Group have yet to disclose what specific indications they plan to prioritize.
When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.
Recent deals from Pfizer and Bristol Myers Squibb hint at Big Pharma’s more collaborative approach to partnering with Chinese companies.
Government backing, deep scientific talent and a robust pharma heritage are helping France punch above its weight, but turning research into investable companies remains a challenge.
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape.
Seventeen life sciences businesses awarded Massachusetts tax incentives to add and retain 426 combined jobs hit 10% of that target as of Dec. 31. Three companies, including Novartis, had reported layoffs either last year or this year.
Edgewise Therapeutics will now focus on a handful of cardiovascular programs including EDG-7500 for hypertrophic cardiomyopathy thanks to the non-dilutive capital from France’s Servier.
Swiss service provider CordenPharma is acquiring AmbioPharm, gaining facilities such as a plant in South Carolina to provide a fully U.S.-based supply.