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While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
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AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage.
Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar.
Deerfield Management claims that Alcon Research is seeking a discounted takeover of Aurion Biotech while blocking the startup’s efforts to go public.
The industry remains unwavering in the commitment to increased clinical trial accessibility and representation.
Price-negotiation provisions that are out of step with reality are discouraging funders and Big Pharma partners from investing in potentially transformative therapies. Fixing some of the unintended consequences of the IRA will clear the way for innovative medicines to reach patients in need.
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
The World Health Organization names antimicrobial resistance as one of the most urgent public health threats, but it remains an unattractive target for the pharmaceutical industry due to its weak profitability.
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.