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The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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As Congress debates renewing the Act for ALS, it must prepare for the coming era of precision ALS medicine by prioritizing early-stage research to more quickly bring effective treatments to the market.
Protagonist Therapeutics will now sit back and collect cash from the J&J partnership, including an immediate $50 million payment.
While Johnson & Johnson retains the top revenue rank across the major pharma companies, Eli Lilly last year established itself as the clear leader in the obesity market, in the process capturing investors’ attention and enthusiasm.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
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With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.
The company is establishing commercial production capabilities to fuel plans to launch autologous CAR-T cell therapies in China.
Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is still unknown.
Eli Lilly’s retatrutide could present a “differentiated option” for patients with type 2 diabetes who want to control their blood sugar and achieve maximal weight loss, according to analysts at BMO Capital Markets.
Gossamer Bio reported last month that its only late-stage candidate failed a Phase 3 study in pulmonary arterial hypertension, casting doubt on the asset’s future prospects.
Prime biotech buyout targets such as Revolution Medicines and Ascendis Pharma have recently found themselves in the middle of acquisition rumors—though no deals have panned out so far.
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
In this episode of Denatured, you’ll listen to Viswa Colluru, CEO and founder of Enveda and Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest. We speak about how AI platforms must now prove themselves through proprietary data, focused pipelines and clinical readouts in competitive diseases to garner investor interest.
Recruiters can play a significant role in biopharma professionals getting hired, especially in an employer-driven job market. However, when working with them, candidates need to avoid making six key mistakes, from waiting too long to ask for help to prematurely contacting hiring companies.
Constructing the cGMP facility will increase availability of actinium-225, a nuclear material central to radiopharmaceutical programs at AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis.