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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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While the companies did not reveal the financial details of the deal, Novo Nordisk will provide funding for two Evotec sites in Germany and Italy to support the development of next-generation cell therapies.
Based on new safety signals, Pfizer on Wednesday announced that Oxbryta’s overall benefit “no longer outweighs the risk” in patients with sickle cell disease. Guggenheim Securities analysts said the setback increases investor frustrations with the company’s business development track record.
A retrospective cohort study of more than 33,000 patients with type 2 diabetes showed that Novo Nordisk’s GLP-1 may lower the risk of opioid overdose by 42% to up to 68%.
New research has found that MS patients treated with anti-CD20 antibodies, such as Roche’s Ocrevus, do not experience significantly slower progression of disability.
Dealing with a toxic co-worker can be exhausting, and it can make your workplace more stressful. There are a few ways to make it easier, including developing healthy coping mechanisms and even talking it out with your colleague.
In a Tuesday Senate hearing on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs.
Many Big Pharma companies including Pfizer, Merck and BMS make the drugs that some researchers expect to be selected by CMS for next year’s Medicare price negotiations alongside analysts’ top pick, Novo Nordisk’s Ozempic.
Merck follows in the footsteps of Bristol Myers Squibb, which in December 2023 also failed to secure a late-stage victory for its combo regimen of a PD-1 blocker and an anti-LAG-3 antibody.
Jefferies analyst Michael Yee in a note to investors called rocatinlimab’s atopic dermatitis data “modest,” noting that the OX40 receptor blocker “came in at the lower end of efficacy and expectations,” but found Uplizna’s performance in generalized myasthenia gravis “better than expected.”
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.