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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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Weight loss giant Eli Lilly has penned a DNA editing deal with Profluent Bio, continuing its dealmaking spree as well as its commitment to artificial intelligence.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
Executives insist Novartis will return to growth in the second half, but for Q1 2026, generic erosion drove a 5% drop in revenue, including a 46% nosedive for blockbuster heart failure drug Entresto.
Coultreon Biopharma is advancing assets that target salt-inducible kinases, proteins that drive inflammation and other immune-mediated conditions.
Fresh off a major clinical win, Revolution Medicines alleges that Erasca’s pancreatic cancer drug infringes on key patent protections and that the rival has “improperly compared” the companies’ assets publicly.
The new CEO has at least five years and a large M&A war chest to position Sanofi for life after the loss of exclusivity on its cornerstone immunology product.
While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
Sun Pharmaceutical is bringing Merck spinoff Organon into the fold, paying $11.75 billion in hopes of becoming a top global biosimilar player.
Eli Lilly is picking up Ajax Therapeutics and its once-daily oral blood cancer candidate. The deal follows the pharma’s buyouts of ADC specialist CrossBridge Bio and in vivo CAR T company Kelonia Therapeutics.
With Phase 3 data in hand, Intellia Therapeutics is seeking approval for its in vivo CRISPR gene editing therapy for hereditary angioedema.