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  • Johnson & Johnson prepares $2.58 billion option to acquire Sail Biomedicines, expanding in-vivo CAR-T portfolio
    Johnson & Johnson announced a $2.58 billion option agreement to purchase Sail Biomedicines, a Flagship Pioneering‑backed biotech focused on in‑vivo CAR‑T therapies. The deal includes an upfront pa…
    Endpoints · 5h agoDealNeutral↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 15h agoRegulatoryNegative↗ source
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  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 17h agoApprovalPositive↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 13h agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 14h agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 15h agoRegulatoryNegative↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 18h agoPositive readoutPositive↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 23h agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 23h agoDealPositive↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 23h agoEarningsPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 16h agoRegulatoryNeutral↗ source
  • Two biotech firms announce reverse mergers to list experimental bispecific antibody and BTK inhibitor on Nasdaq
    Two biotech companies have each entered reverse merger agreements to become publicly traded on Nasdaq. One firm, based in China, is developing a bispecific antibody and will use the merger to brin…
    Endpoints · 18h agoDealNeutral↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 21h agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 22h agoDealNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Merck briefly lists, then removes, phase 2 trial of PD-1xVEGF bispecific with TROP2 ADC
    Merck & Co. posted a clinical trial listing for a phase‑2 study combining its PD‑1xVEGF bispecific antibody (MK‑2010) with the TROP2‑directed antibody‑drug conjugate sac‑TMT. The listing, shown as…
    Fierce Biotech · 19h agoNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 21h agoDealNeutral↗ source
  • Former Recursion CEO Chris Gibson joins Dimension Capital as operating partner
    Chris Gibson, who led Recursion Pharmaceuticals for a decade, has taken a new role at venture firm Dimension Capital. At Dimension, he will serve as an operating partner, bringing his experience a…
    Endpoints · 22h agoPositive↗ source
  • NYU's Neil Vasan steps down as acting chair of FDA's oncology drug advisory committee
    Neil Vasan, a professor at NYU, has announced he is stepping down from his role as acting chair of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Vasan has participated in 22 ODAC meetings a…
    Endpoints · 16h agoRegulatoryNeutral↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 2d agoLayoffsNegative↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 1d agoRegulatoryNeutral↗ source