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Illumina wins FDA approval for test to identify treatable cancers

The FDA has approved DNA sequencing giant Illumina’s cancer test that checks more than 500 genes in a tumor to potentially match patients with targeted therapies from Bayer or Eli Lilly. Illumina has...

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Invivyd says new Phase 3 data on Covid antibody support prophylactic use

Invivyd’s monoclonal antibody can cut the risk of contracting Covid-19 in both healthy and immunocompromised people, according to the latest exploratory analysis from a Phase 3 trial. The biotech’s...

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Former Regenxbio leaders take rare disease gene therapies to startup with $15M

Two Regenxbio gene therapies are getting a second chance at newly-seeded startup Tern Therapeutics, which launched from stealth Tuesday with $15 million. In November, Regenxbio announced it was laying...

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Redalpine closes $200M fund; A base editing pact in China; Merck starts...

Plus, a Phase 3 fail from a small public company: Redalpine’s $200M fund: The nearly two-decade-old VC firm closed its sixth early-stage fund, dubbed RAC VII. The Zurich-based firm has invested in...

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Once-promising cancer drugs appear to protect mice from Alzheimer’s

Drugs designed to help the immune system fight cancer might also stave off dementia, according to a study in mice. Researchers at Stanford University discovered a new role for the metabolic enzyme IDO1...

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Duality Biologics, an ADC partner of BeiGene and BioNTech, files for Hong...

Clinical-stage antibody-drug conjugate startup Duality Biologics has filed for an initial public offering in Hong Kong, where there have been only a handful of biotech listing debuts in recent...

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AstraZeneca pours $135M into boosting biologics capacity in Sweden 

AstraZeneca is spending $135 million to expand a biologics facility in Sweden due to an increase in demand for its pre-filled syringe drug products, a company spokesperson told Endpoints News. The...

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Eli Lilly releases single-dose vials of Zepbound at half the price of other...

Eli Lilly will begin selling single-dose vials of its drug tirzepatide, marketed as Zepbound for weight loss, and price them at least 50% lower than the list price of all other incretin medicines for...

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Widening GLP-1 coverage could cost Medicare almost $150B annually, study finds

As Congress considers widening Medicare’s coverage of the burgeoning class of weight loss medications, a new study says further expansion of eligible patients into new indications could cost a pretty...

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Biopharma companies, BARDA call for more clarity on FDA's new platform tech...

Following the FDA’s May release of long-awaited draft guidance explaining how companies can win designations for certain cell and gene therapy “platform” technologies, companies like Regeneron,...

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Ipsen files another Onivyde lawsuit two weeks after receiving new patent

Two weeks after receiving a new patent on its pancreatic cancer treatment Onivyde, Ipsen has filed another lawsuit against a potential competitor. Ipsen argued on Friday that Conjupro Biotherapeutics’...

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Pfizer partners with Flagship genetics startup Quotient on heart and kidney...

Pfizer has struck its second partnership with a Flagship Pioneering startup, working with Quotient Therapeutics to identify genetic mutations that arise by chance throughout life and make individual...

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California Institute for Immunology and Immunotherapy gets $120M gift for...

Surgeon Gary Michelson and his wife Alya have donated $120 million to a Los Angeles-based public-private initiative focused on advancing research into immunology and vaccines. The Michelsons’ gift to...

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Noetik raises $40M Series A to advance AI ambitions in cancer — with an...

After serving as Pfizer’s top lawyer and now chairing Alnylam’s board, Amy Schulman’s latest biotech bet could be seen as somewhat of a surprise. The managing partner of venture capital firm Polaris...

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Bayer partners with RNA startup launched out of Dana-Farber

Even as Bayer continues cutting costs across its conglomerate, it’s still making some small R&D deals to add to its pipeline. On Wednesday, the German multinational pharma and NextRNA Therapeutics...

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Neurocrine's schizophrenia data are good enough for Phase 3 — but maybe not...

Neurocrine Biosciences’ effort to chase down Bristol Myers Squibb and Karuna Therapeutics in schizophrenia just got more complicated. In a Phase 2 readout Wednesday morning, Neurocrine reported that...

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Novartis partners with small North Carolina biotech to make its biologics...

Novartis announced a collaboration on Wednesday with a small North Carolina biotech whose technology could help turn more of the Swiss pharma giant’s infused drugs into injections that patients can...

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Novartis seeks to expand Leqvio into heart disease prevention

Novartis announced Wednesday that Leqvio lowered bad cholesterol levels, compared with a placebo or the cholesterol-lowering drug ezetimibe, in patients at low-to-moderate risk of developing...

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SpringWorks gets priority review; Botox competitor data; Hyundai's Covid...

SpringWorks scores FDA priority review: The agency accepted mirdametinib’s new drug application and granted it a priority review for the treatment of adult and pediatric patients with neurofibromatosis...

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FDA warns EyePoint over eye implant manufacturing woes

The FDA has sent EyePoint Pharmaceuticals a warning letter after uncovering manufacturing issues with the company’s eye implant Yutiq. The letter, issued July 12 and published Tuesday, said FDA...

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