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  • 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
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
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  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 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
  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 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
  • 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
  • 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
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatment
    The U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol. The drug blocks the PCSK9 protein, making it the first pill…
    BioPharma Dive · 1mo agoApprovalPositive↗ 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
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo 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 · 1mo agoDealPositive↗ 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 · 1mo agoLayoffsNegative↗ source
  • Veradermics' experimental hair loss pill shows promising results in women
    Veradermics reported positive Phase 2 data for its oral minoxidil formulation VDPHL01 in women with mild-to-moderate pattern hair loss. The study enrolled 28 participants who took the drug once or…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoEarningsNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source