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  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 4mo agoNegative readoutNegative↗ source
  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 4mo agoDealPositive↗ source
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  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 4mo agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 4mo agoRegulatoryNegative↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 4mo agoDealPositive↗ source
  • GSK halts camlipixant development after mixed Phase 3 results curb blockbuster hopes
    GSK announced it is stopping work on camlipixant, a P2X3 receptor antagonist it bought when acquiring Bellus Health in 2023, after the drug produced mixed results in two Phase 3 chronic cough trial…
    Fierce Biotech · 4mo agoNegative readoutNegative↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 4mo agoDealPositive↗ source
  • Fierce Biotech flags five cities poised to become next biotech powerhouses
    Fierce Biotech’s latest special report identifies five cities that could emerge as major biotech hubs. The podcast episode of “The Top Line” highlights Boston, San Francisco, Beijing, Seattle and C…
    Fierce Biotech · 4mo agoPositive↗ source
  • Taylor Fresh Foods recalls all iceberg lettuce from central Mexico over possible Cyclospora contamination
    Taylor Fresh Foods, operating as Taylor Farms de Mexico in Guanajuato, is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market because of a potential Cyclospora…
    fda recalls · 4mo agoCRLNegative↗ source
  • Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol
    Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
    BioSpace · 4mo agoApprovalPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 4mo agoDealPositive↗ source
  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 4mo agoPositive readoutPositive↗ source
  • InnoCare’s TYK2 inhibitor soficitinib meets primary endpoint in phase 2 vitiligo trial
    InnoCare Pharma announced that its TYK2 inhibitor soficitinib achieved the primary endpoint in a phase 2 study of non‑segmental vitiligo conducted at sites in China. The trial evaluated daily oral…
    Fierce Biotech · 4mo agoPositive readoutPositive↗ source
  • Biopharma layoffs may exceed 14,000 jobs in H1 as Takeda, BioNTech and Viatris cut staff
    Biopharma firms are preparing for a wave of job cuts in the first half of 2026, with total layoffs projected to affect more than 14,000 employees, according to data compiled by BioSpace. The bulk…
    BioSpace · 4mo agoLayoffsNegative↗ source
  • FDA issues first AI-focused cGMP warning letter, flagging oversight gaps for manufacturers
    The FDA has issued its first warning letter that explicitly addresses the use of artificial intelligence in pharmaceutical manufacturing, targeting Purolea Cosmetics Lab. The letter cites AI‑gener…
    BioSpace · 4mo agoRegulatoryNegative↗ source
  • Three biotech firms launch IPOs to challenge giants in cardiometabolic and immunology markets
    Braveheart Bio, Attovia Therapeutics and Vogenx filed for initial public offerings this week, adding to a surge of biotech listings in 2026. Braveheart is developing a therapy for hypertrophic car…
    BioSpace · 4mo agoDealNeutral↗ source
  • Podcast explores non-opioid and regenerative approaches to pain relief
    In a recent episode of the Denatured podcast, Lance Alstodt, chairman and CEO of BioRestorative Therapies, and Paul Mieyal, chief business officer of South Rampart Pharma, discuss why pain remains…
    BioSpace · 4mo agoPositive↗ source
  • J&J reports 40% Q2 sales jump for Spravato as psychedelic rivals loom
    Johnson & Johnson said its depression nasal spray Spravato generated $584 million in worldwide revenue in the second quarter, a 40% increase from a year earlier. The company highlighted the drug as…
    BioSpace · 4mo agoEarningsNeutral↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 4mo agoPositive↗ source
  • Khong Guan recalls glutinous rice balls with black sesame filling over possible undeclared peanuts
    Khong Guan Corporation announced a recall of certain lots of its Glutinous Rice Balls with Black Sesame Filling after discovering they may contain undeclared peanuts. The product, sold in 14.1‑oz…
    fda recalls · 4mo agoRegulatoryNegative↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 4mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 4mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 4mo agoPositive↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 4mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 4mo agoPositive↗ source