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  • 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 · 2d 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 · 2d agoDealPositive↗ source
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  • 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoDealNeutral↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 2d agoRegulatoryNegative↗ 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 · 2d 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
  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 2d agoCRLNegative↗ 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
  • 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 · 3d 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 · 3d 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 · 3d 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 · 3d agoRegulatoryNeutral↗ source
  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 3d agoRegulatoryNeutral↗ source
  • Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3
    💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...
    Endpoints · 3d agoNeutral↗ source
  • Alnylam's stock is down 30% despite a booming biotech market. Here's why
    Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A is up, IPOs are back with record-breaking force a…
    Endpoints · 3d agoNeutral↗ source
  • Mirae raises $5.4M to turn patient texts into data for doctors
    As people increasingly turn to AI chatbots for health questions, one startup wants patients to talk to its chatbot about their symptoms, so their doctors can make better treatment decisions. Mirae,…
    Endpoints · 3d agoNeutral↗ source