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With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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After a quarter in which sales topped $15 billion and key readouts went AstraZeneca’s way, the company is increasingly confident that its 2030 revenue target is in reach.
While sales for most of GSK’s shots slumped as vaccine skepticism continues to climb in the U.S., Shingrix jumped 20% to almost $1.4 billion in the first quarter, emerging as the pharma’s top-selling product.
The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year.
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
Analysts will be watching as a generic version of semaglutide—marketed by Novo Nordisk as Wegovy for weight loss—launches in Canada as a test case for future price erosion in the U.S.
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.
Phase 2 data from PTC Therapeutics showed that the Novartis-partnered Huntington’s disease asset slowed progression by more than 50%. Analysts say the decision to initiate a last-stage trial reflects a lack of confidence in an accelerated FDA nod.
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
Angel investors are raising the bar with tighter criteria, backing strong teams, realistic markets and clear paths to exit while applying deeper, domain-specific diligence to early stage bets.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.