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  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027 after 12-year tenure
    Takeda announced that its longstanding head of research and development, Andy Plump, will step down and retire in June 2027. Plump has been with the Japanese drugmaker for about 12 years, leading…
    BioSpace · 1mo agoNeutral↗ source
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  • Tyra Biosciences shares tumble as bladder cancer pill shows lower-than-expected complete response
    Tyra Biosciences presented Phase 2 SURF302 data for its investigational oral drug dabogratinib in patients with low‑grade intermediate‑risk non‑muscle invasive bladder cancer. The trial reported th…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • August 2026 biopharma layoffs affect just over 500 workers, a 90% drop from a year earlier
    In August 2026, twelve biotech and pharmaceutical firms announced workforce reductions, impacting a total of about 526 employees. This represents a sharp 90% decline in the number of people affecte…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 1mo agoRegulatoryNeutral↗ source
  • CDMOs Redefine Pharma Supply Chains with AI, Cold-Chain Logistics and Smart Sourcing
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer Smith-Parker talks with Arvind Singh, vice-president and global head of supply chain at SK Pharmteco. The discussion is presented…
    BioSpace · 1mo agoNeutral↗ source
  • AI transforms talent strategy in life-science companies, moving from tools to strategic intelligence
    Applying artificial intelligence and automation has moved from experimental use to a core topic in talent strategy discussions across life‑science firms. Early efforts focused on testing tools and…
    BioSpace · 1mo agoPositive↗ source
  • BioSpace reports 11 California biopharma firms posting over 400 jobs as openings rise 31% YoY
    BioSpace's latest job trend data shows a sharp increase in biopharma openings in California, with postings up 31% year-over-year in August. More than 400 positions are currently listed, reflecting…
    BioSpace · 1mo agoNeutral↗ source
  • Novo Nordisk halts two IL-6 heart trials as Novartis suffers Phase 3 setbacks; Ionis wins first Alexander disease approval
    Novo Nordisk announced it has ended two late‑stage studies of its investigational IL‑6 inhibitor ziltivekimab, which was being evaluated for cardiovascular disease. The decision follows an earlier…
    BioSpace · 1mo agoNegative↗ source
  • Sandoz to invest $1 billion in European biosimilar hub, targeting 100 biosimilars by 2040
    Sandoz announced at its investor day that it will spend roughly $1 billion to build a fully integrated European biosimilar hub as part of a plan to bring more than 100 biosimilars to market by 2040…
    BioSpace · 1mo agoPositive↗ source
  • Solstice Oncology secures $225M Series A to launch FDA-cleared Phase 2 CTLA-4 antibody trial
    Solstice Oncology, a cancer-focused startup that emerged from stealth in February, announced a $225 million Series A financing round to fund its early-stage programs. The capital will be used to a…
    BioSpace · 1mo agoDealPositive↗ source
  • Webinar explores how GLP-1 obesity drugs are reshaping US healthcare and market dynamics
    The upcoming webinar titled "The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets" will examine how GLP-1 receptor agonists used for obesity are altering the U.S. health-care landsc…
    BioSpace · 1mo agoNeutral↗ source
  • BMS reports positive mid-stage results for arlo-cel in heavily pre-treated myeloma patients
    BMS said its CAR T therapy arlo-cel, formally arlocabtagene autoleucel, achieved positive results in a registrational mid-stage study for relapsed and refractory multiple myeloma. The open-label,…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Caspian Therapeutics launches with $50M funding and Eli Lilly backing to develop menin inhibitor for diabetes
    Caspian Therapeutics has been created as a spin-out from Kura Oncology to advance a menin-targeting drug for diabetes. The company received $50 million in initial capital, led by BVF Partners with…
    BioSpace · 1mo agoDealPositive↗ source
  • Biopharma looks beyond China to five alternative overseas markets amid rising geopolitical tensions
    Geopolitical tensions between the United States and China are prompting biopharma companies to look beyond the Chinese market for growth. China remains the leading destination, with licensing deal…
    BioSpace · 1mo agoNeutral↗ source
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA makes acting CBER and CDER heads permanent, signaling leadership continuity
    FDA promoted Michael Davis and Karim Mikhail from acting to permanent heads of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The ap…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Career setbacks offer data points, not definitive verdicts, says executive coach
    Angela Justice, an executive coach, describes how a sudden layoff can feel like a verdict but is really just a data point. She warns that people often turn the specific lesson from a setback into…
    BioSpace · 1mo agoNeutral↗ source
  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Structure Therapeutics reports oral GLP-1 weight-loss results comparable to Wegovy and strong Phase 1 amylin data
    Structure Therapeutics announced that its oral GLP-1 candidate aleniglipron achieved 72-week weight-loss results that BMO Capital Markets said were in line with Novo Nordisk’s oral Wegovy. Particip…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Novo Nordisk halts two more late-stage heart failure trials, calling IL-6 an invalid target
    Novo Nordisk said it is ending two late-stage heart-failure studies, HERMES and ATHENA, that were testing its IL-6 inhibitor ziltivekimab. The company cited a recommendation from the Data Monitorin…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer
    FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients. The indicatio…
    BioSpace · 1mo agoApprovalPositive↗ source