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  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Veteran scientists launch nonprofit Center for Therapeutic Genetics to advance personalized gene therapies
    A group of experienced researchers from top institutions has created the nonprofit Center for Therapeutic Genetics (CTG) to develop personalized genetic medicines. CTG will operate from a modest s…
    Fierce Biotech · 1mo agoPositive↗ source
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  • BMS partners with Nvidia to build the largest AI supercomputer for drug research
    Bristol Myers Squibb announced an expanded partnership with Nvidia aimed at creating the biggest AI‑driven supercomputing platform for its drug discovery and development work. The new system will…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Geopolitical uncertainty dampens UK biotech IPO outlook despite record Q2 venture funding
    Geopolitical uncertainty continues to weigh on the sentiment around initial public offerings for British biotech companies, according to an industry leader speaking to Fierce. At the same time, th…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Abbott reports cyberattack on cancer diagnostics and LabCentral portal, says operations unaffected
    Abbott announced that a cyber incident on July 16 accessed a limited number of internal systems in its cancer diagnostics unit. The company said the breach does not affect product availability, ma…
    Fierce Biotech · 1mo agoNegative↗ source
  • Eli Lilly’s $2.8 bn purchase of AtaiBeckley adds psychedelic candidate BPL‑003, sparking optimism for broader mental‑health drug pipeline
    Eli Lilly announced it has acquired AtaiBeckley for $2.8 billion, bringing the privately held biotech’s lead psychedelic program into its portfolio. The deal gives Lilly access to BPL‑003, an intr…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Abbott Beats Q2 Expectations with Strong Device and Diagnostic Sales, Raises Profit Forecast
    Abbott reported second‑quarter results that exceeded analysts' forecasts, easing concerns about potential impact of ACA subsidy cuts on medtech firms. Diagnostics revenue jumped 42% year‑over‑year…
    Fierce Biotech · 1mo agoEarningsPositive↗ source
  • Dimerix acquires Mission's phase-2 ready AKI drug in $292 million deal
    Dimerix announced it has acquired the acute kidney injury candidate MTX652 from Mission Therapeutics in a deal valued at up to $292 million, including a $5 million upfront payment. Mission had com…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source
  • 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 1mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 1mo agoRegulatoryNegative↗ 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 · 1mo agoPositive↗ 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 · 1mo agoApprovalPositive↗ source