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What would RFK Jr. do on healthcare? Trump ally's FDA plans raise alarm

Donald Trump's embrace of Robert F. Kennedy Jr. is forcing biotech and pharma leaders to grapple with having US life sciences policy influenced by a figure who has extensively criticized vaccines and...

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Following March inspection, Novo Nordisk's semaglutide manufacturing facility...

The FDA on Tuesday released an inspection report sent to Novo Nordisk earlier this year citing quality-related issues at a site in Kalundborg, Denmark, that manufactures its blockbuster semaglutide...

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Pfizer shares new details on obesity pipeline, hints at ‘other opportunities’

As Pfizer talked up the strength of its pipeline Tuesday, it shared details for the first time about its plans in obesity and said it has a multi-pronged strategy to catch up to rivals in ...

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Zurzuvae won't be developed for major depression, Sage says

It’s official: Sage and Biogen will not attempt to get their postpartum depression pill Zurzuvae approved in the broader population of people with major depressive disorder. Sage, which has recently...

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Axonis snags $115M to test oral drugs for epilepsy and neuropathic pain

Boston biotech Axonis Therapeutics has raised a $115 million Series A to test whether its oral drug AXN-027 can help patients with focal epilepsy and diabetic neuropathic pain. The financing, disclosed...

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GSK remains ‘very confident’ in RSV vaccine amid competition, sales slump

Competition is heating up in the RSV space, despite a lukewarm quarter for vaccine uptake. Pfizer beat GSK’s Arexvy for the first time in the third quarter, as Arexvy sales dipped 72% from the year ...

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Nobel winner David Baker co-founds another startup, as Archon takes an AI...

The newest David Baker biotech startup launched Wednesday, as Archon Biosciences has raised a $20 million seed round to develop what it believes could be a new class of antibody-based drugs. The...

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Updated: Lilly’s shares tank after trimming revenue guidance. It also cut...

Eli Lilly lowered the top end of its full-year revenue guidance by $600 million on Wednesday, as its third-quarter sales were about $800 million below Wall Street’s expectations. The pharma giant had...

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Biogen signs molecular glue deal, raises yearly projections

Is 2024 the year of molecular glues? Biogen on Tuesday became the latest company to partner on the increasingly popular subject, teaming up with private San Diego biotech Neomorph. Biogen will pay...

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Blue Earth Therapeutics snags $76M for both alpha and beta radiotherapies

The radiopharma field continues to buzz with private financings and more clinical-stage programs. The latest is Oxford, UK-based Blue Earth Therapeutics, which unveiled a $76.5 million Series A on...

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Lundbeck doubled its offer for Longboard over six months, new filing shows

Danish pharma Lundbeck vastly increased its offer to buy Longboard Pharmaceuticals over six months as other parties came to the dealmaking table, a new SEC filing shows. Lundbeck initially proposed $29...

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Leal Therapeutics raises $45M; SynOx adds to Series B

Plus, news about Zai Lab, Spero Therapeutics and EyePoint Pharmaceuticals: Leal Therapeutics raises $45M: The biotech, which emerged from stealth earlier this year, said the financing was led ...

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GSK cuts 24-valent pneumococcal program for adults due to competition

GSK is setting aside a mid-stage 24-valent pneumococcal vaccine program for adults to instead focus on a preclinical option that covers 30-plus valents, the company announced Wednesday alongside its...

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AstraZeneca China exec probed by local authorities

AstraZeneca said Wednesday its China president Leon Wang is under investigation in the country, days after it was reported a BeiGene exec was under scrutiny for insurance fraud while she was ...

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FDA says all versions of Novo's GLP-1 weight loss drugs are now available

The FDA on Wednesday updated its drug shortage database to say that all dosages and versions of Novo Nordisk's Wegovy and Ozempic are now "available." A Novo spokesperson ...

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Biogen seeks growth from pipeline as investors show signs of impatience

Biogen's investors are growing restless. Wednesday's third-quarter earnings call checked most of the boxes for a successful report. The company raised its full-year guidance, and sales of its...

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Atlas of tumors reveals in 3D how cells change into cancer

The story of cancer has long started with a single mutated cell that divides and eventually grows into a tumor causing disease and death. But new research, part of a large-scale effort to map in ...

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AbbVie’s immunology blockbusters make up for Humira sales drop in Q3

AbbVie is lifting its profit outlook and full-year 2024 guidance as its immunology blockbusters Skyrizi and Rinvoq beat quarterly revenue estimates, according to the company’s third-quarter filing....

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Roche presents early-stage results for latest amyloid-based Alzheimer's attempt

Roche revealed early-stage data for a new Alzheimer’s program on Wednesday as it seeks to jump back into a field littered with failures. In a 60-patient trial testing four different doses of...

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Lexeo shares early data on Alzheimer’s gene therapy 

Lexeo Therapeutics shared biomarker data from 15 patients in a Phase 1/2 study of its gene therapy for Alzheimer’s disease. The hope is that the gene therapy can slow progression of ...

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