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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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The Anglo-Swedish drugmaker is making the investment to bolster its vaccine manufacturing and research and development capabilities in the U.K.
President Joe Biden has proposed expansions to the Inflation Reduction Act, including an increase in the annual number of prescription drugs that would be subject to price negotiations to 50, up from 20.
The early-stage oncology startup filed for an initial public offering on Wednesday, seeking funds to help develop its novel cancer therapies targeting extrachromosomal DNA.
The recently launched company shared two posters at the Muscular Dystrophy Association’s annual conference this week ahead of a March 21 PDUFA date.
Presentations are standard requirements in the hiring process for some biopharma positions. Here’s how to approach them.
A mid-stage study of Alnylam Therapeutics’ experimental RNAi-based drug to treat hypertension met its primary endpoint.
Separate challenges exist for companies developing gene therapies for rare and common cardiovascular conditions, experts told BioSpace.
Sionna Therapeutics on Wednesday announced it raised another round of funding as the company looks to challenge Vertex Pharmaceuticals’ dominant cystic fibrosis business.
Sandoz’s two interchangeable biosimilars, Jubbonti and Xgeva, are poised to challenge Amgen’s blockbuster bone drug denosumab. However, no launch details were announced Tuesday due to ongoing patent litigation.
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.