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958 stories matching this filter · ← front page

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  • 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 · 2d 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 · 2d agoDealPositive↗ source
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Nephrology239
  • 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 · 2d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 2d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 2d agoRegulatoryNeutral↗ source
  • Hansoh and GSK's B7-H3 ADC shows progression-free survival benefit in phase 3 osteosarcoma trial in China
    Hansoh Pharmaceutical, in partnership with GSK, announced that its B7‑H3‑directed antibody‑drug conjugate (ADC) met the primary endpoint in a phase 3 study of relapsed osteosarcoma patients in Chin…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Atea’s hepatitis C combo matches Gilead’s Epclusa in phase 3 trial
    Boston-based biotech Atea Pharmaceuticals reported that its once-daily hepatitis C combination of bemnifosbuvir and ruzasvir performed on par with Gilead's Epclusa in a pivotal phase 3 study. The…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • FDA warns investors that advisory panel reviews do not guarantee drug approval, cites concerns at Capricor and Replimune
    The FDA issued a reminder to investors that the outcomes of advisory committee meetings are not final decisions on a drug’s fate. This week the agency released briefing documents highlighting conc…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • J&J offers $5.5 billion settlement to resolve talc lawsuits
    Johnson & Johnson has put forward a settlement proposal of $5.5 billion to end the litigation over its talc products. The proposal follows more than a decade of legal battles and three unsuccessfu…
    Endpoints · 3d agoDealNeutral↗ source
  • FDA updates guidance for generic makers of top GLP-1 weight-loss drugs
    The FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 4d agoPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Boston Scientific launches multi-year restructuring plan, foresees $500 million annual savings and job cuts
    Boston Scientific announced a global restructuring program that will run from this year through 2029, aiming to streamline its supply chain and reorganize functions. The plan involves moving certa…
    Fierce Biotech · 4d agoLayoffsNeutral↗ source