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1,492 stories matching this filter · ← front page

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  • J&J's Halda-derived prostate cancer drug shows 75% response in early Phase 1 trial
    Johnson & Johnson's recent $3 billion purchase of Halda Therapeutics added an oral prostate cancer candidate, JNJ-6143, to its pipeline. The drug targets a cancer-specific protein to trigger cell d…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 19d agoNegative readoutNegative↗ source
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  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 19d agoNeutral↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 19d agoNeutral↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 19d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 19d agoApprovalNeutral↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 19d agoNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 19d agoRegulatoryNeutral↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 19d ago↗ source
  • ESMO 2026: Merck’s Kelun-partnered ADC cuts death risk by over 30% in endometrial cancer
    Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first…
    BioSpace · 19d ago↗ source
  • Roche warns Germany faces last chance to regain pharma investment confidence
    Roche has said that recent German healthcare reforms threaten the country's attractiveness for pharmaceutical investment. The company paused its own German investment plans after the reforms were a…
    BioSpace · 22d agoRegulatoryNegative↗ source
  • Marengo's bispecific antibody invikafusp alfa shows tumor shrinkage in 8 cancer types in Phase 2
    Marengo Therapeutics presented Phase 2 data for its bispecific antibody invikafusp alfa at the European Society for Medical Oncology meeting in Madrid. The study, part of the Start-001 first‑in‑hum…
    BioSpace · 22d agoPositive readoutPositive↗ source
  • Alnylam to launch pivotal Huntington’s trial after early study shows strong huntingtin knockdown
    Alnylam Pharmaceuticals announced plans to move its Huntington’s disease RNAi therapy brezosiran into a pivotal, placebo‑controlled trial slated for 2027, pending regulatory alignment. The decisio…
    BioSpace · 22d agoPositive readoutPositive↗ source
  • Tango Therapeutics reports 82% response rate for vopimetostat plus Rasonque in pancreatic cancer, down from 92% earlier
    Tango Therapeutics announced updated data from its ongoing Phase 1/2 trial combining its PRMT5 inhibitor vopimetostat with Revolution Medicines' newly approved drug Rasonque (daraxonrasib) in secon…
    BioSpace · 22d agoNegative readoutNegative↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 22d agoDealPositive↗ source
  • BMS reports fatal septic pneumonia in MS patient during CAR T trial of zolacabtagene autoleucel
    BMS disclosed that a participant in its Phase 1 Breakfree-2 study of the CAR T cell therapy zolacabtagene autoleucel died from septic pneumonia. The patient, who had highly active relapsing multip…
    BioSpace · 21d agoNegative readoutNegative↗ source
  • RNAi developers see surge in IPOs and funding as industry interest revives
    BioPharma Dive’s latest data‑visualization series highlights a rapid rise in interest and investment for companies developing RNA interference (RNAi) medicines. After a years‑long lull, more than…
    BioPharma Dive · 22d agoPositive↗ source
  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 22d agoRegulatoryNeutral↗ source
  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 22d agoCRLPositive↗ source
  • Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
    Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
    BioSpace · 22d agoDealNeutral↗ source
  • Star raises $200 million after successful spinouts of Electra and Vega Therapeutics
    Star, a biopharma company, announced it has secured $200 million in new funding. The capital follows the recent exits of its subsidiaries Electra Therapeutics and Vega Therapeutics, which were spu…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 22d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 22d agoNeutral↗ source
  • Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
    Gilead Sciences has picked up a new inflammatory disease program from China’s PepStar Therapeutics to pair with the Phase 2 inflammatory bowel disease asset emvistegrast.
    BioSpace · 22d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 22d ago↗ source