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Regeneron wins EU approval for lymphoma bispecific following FDA rejection

EU regulatory authorities granted conditional approval to Regeneron’s bispecific antibody odronextamab for two forms of lymphoma. It’s Regeneron’s first bispecific antibody approval in the world after...

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Another major PBM will cut AbbVie's Humira from its largest commercial...

Cigna’s pharmacy benefit manager Express Scripts said it will remove Humira from its largest commercial drug formularies in 2025 to make way for its biosimilars. The move will make Express Scripts the...

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Novartis to sell molecular imaging business to Siemens Healthineers

Novartis is selling off its molecular imaging business for positron emission tomography (PET) scans to Siemens Healthineers for an undisclosed amount, both companies confirmed to Endpoints News on...

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Federal agency opposes J&J's new 340B discount model, promises to take...

The federal government is challenging Johnson & Johnson’s plan to change how some hospitals receive drug price discounts under the 340B program. Last week, J&J announced that beginning Oct. 15,...

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Swiss biotech's inhibitor of cancer driver shows promise in rare bleeding...

Vaderis Therapeutics announced Tuesday morning that its lead drug candidate, an AKT inhibitor, helped reduce nosebleeds in people with hereditary hemorrhagic telangiectasia, a genetic disorder in which...

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Pfizer unveils direct-to-consumer push for Covid, flu and migraine treatments

Pfizer is expanding its direct-to-patient sales offerings. On Tuesday, the New York pharma launched a new website, called PfizerForAll, that connects patients to clinicians who can prescribe its...

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Oculis closes Phase 3 eye drop trial due to 'administrative error' from third...

A Phase 3 trial for Oculis’ lead eye drop candidate will be shut down due to an administrative error, the company reported in its second-quarter financial filing. The OPTIMIZE-2 trial was investigating...

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RA Capital and Forbion set up new autoimmune biotech with bispecific from...

Another autoimmune biotech emerged on Tuesday morning with a $100 million Series A. Navigator Medicines launched with a license to a Phase 1 bispecific antibody and a pipeline of other assets from...

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Elektrofi, a startup that helps drugmakers formulate biologics for easier...

Biologics startup Elektrofi is raising an approximately $112 million Series C, CEO and co-founder Chase Coffman confirmed to Endpoints News. Chase Coffman The Boston-based startup works with pharma and...

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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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