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  • BMS reports Phase 3 success for RYZ101 in GEP-NET trial
    Bristol Myers Squibb said its radiopharmaceutical candidate RYZ101 met the primary endpoint in a late‑stage Phase 3 study. The drug was acquired in BMS's $4.1 billion purchase of RayzeBio, complete…
    BioSpace · 9d agoPositive readoutPositive↗ source
  • Strategic CDMO partnerships shift from transactional to collaborative, emphasizing risk sharing and regulatory expertise
    CDMO-sponsor relationships are moving away from simple outsourcing toward deeper strategic collaboration. Companies now look for partners who share risk, understand regulatory requirements, and pro…
    BioSpace · 9d agoPositive↗ source
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Nephrology643
  • Aspen Neuroscience files for Nasdaq IPO to fund Parkinson’s cell therapy program
    Aspen Neuroscience, founded in 2018, announced plans to list on Nasdaq, aiming to raise additional capital for its Parkinson’s disease cell therapy program. The company's lead candidate, sasinepro…
    BioPharma Dive · 9d agoDealNeutral↗ source
  • Bristol Myers' lung drug admilparant meets Phase 3 goal at low dose, high dose falls short
    Bristol Myers Squibb reported that its experimental idiopathic pulmonary fibrosis therapy admilparant achieved its primary endpoint in a Phase 3 trial, showing a statistically significant slowing o…
    BioPharma Dive · 9d agoPositive readoutNeutral↗ source
  • BMS lung drug meets low-dose endpoint in Phase 3 but high dose fails to improve lung function
    Bristol Myers Squibb reported that its LPA1 antagonist admilparant achieved the primary endpoint in a Phase 3 idiopathic pulmonary fibrosis study at the 60‑mg dose, showing a statistically signific…
    BioSpace · 9d agoPositive readoutNeutral↗ source
  • RevMed's pancreatic cancer drug Rasonque shows mixed results across KRAS subtypes, analysts stay optimistic
    FDA review documents revealed that Revolution Medicines' newly approved pancreatic cancer therapy, Rasonque, performed unevenly in a large subgroup of patients. The data highlight a lower objective…
    BioSpace · 9d agoNegative readoutNeutral↗ source
  • GSK to invest $800 million in new biologics manufacturing hub in Pennsylvania
    GSK announced it will spend more than $800 million to expand its Upper Merion site near Philadelphia, adding biologics production capacity. The plan includes demolishing existing structures next y…
    BioSpace · 9d agoDealPositive↗ source
  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Integrating Multiple Stability Measurements Improves Early Biologics Testing
    John Stenson of Malvern Panalytical argues that combining several stability assays on a single platform can increase both throughput and data quality for early‑stage biologics development. He note…
    BioSpace · 9d agoNeutral↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 9d agoNeutral↗ source
  • Novartis licenses Abogen’s mRNA CD19×CD3 engager in $575M upfront deal
    Abogen Biosciences saw its COVID vaccine miss the market, prompting questions about whether its mRNA platform could be leveraged for other therapies. Novartis agreed to pay $575 million up front f…
    BioSpace · 12d agoDealPositive↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion to expand non‑opioid pain portfolio
    Viatris announced a $1.65 billion acquisition of Pacira BioSciences, aiming to broaden its non‑opioid pain‑relief offerings. The deal includes Pacira's marketed products Exparel and Zilretta, which…
    BioSpace · 12d agoDealPositive↗ source
  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 12d agoRegulatoryNegative↗ source
  • Biotech Index Retraces Gains as Weak Trial Data and Market Fears Weigh
    BioPharma Dive’s latest data‑visualization piece examines why biotech stocks have slipped recently and highlights the rapid pace of startup acquisitions this year. The XBI index, a barometer for b…
    BioPharma Dive · 12d agoNeutral↗ source
  • TRexBio and Retension raise $161.7M in IPOs as biotech fundraising surge continues
    TRexBio and Retension Pharmaceuticals are slated to begin trading on Friday, together raising $161.7 million. Their offerings push the number of biotech IPOs this year to 29, underscoring a continu…
    BioSpace · 12d agoDealPositive↗ source
  • TRex Bio prices $117M IPO to fund Treg-targeted immune therapies
    TRex Bio announced pricing of its initial public offering at $117 million, selling 8,333,334 shares at $14 each, meeting the low end of its earlier guidance. The company will begin trading on Nasd…
    BioPharma Dive · 12d agoDealPositive↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 12d agoRegulatoryNegative↗ source
  • Oliva LLC recalls 250 units of Riad's Oliva to Go dips over undeclared sesame
    Oliva LLC of Bethlehem, Connecticut announced a voluntary recall of about 250 units of its Riad's Oliva to Go line, including Baba Ghanouj, Spicy Baba Ghanouj and Hummus. The recall was triggered…
    fda recalls · 11d agoCRLNegative↗ source
  • Krasnyi Oktyabr Recalls Starfish Seafood Trio Over Listeria Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York announced a voluntary recall of its Starfish Seafood Trio, which includes cold smoked salmon, halibut and trout packaged in 8‑oz vacuum‑sealed packs. The…
    fda recalls · 11d agoCRLNegative↗ source
  • Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be co…
    fda recalls · 12d ago↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 13d agoNegative readoutNegative↗ source
  • Argenx halts late-stage Vyvgart trial in Sjogren’s disease after futility finding, shares tumble 13%
    Argenx announced it is ending the Phase 3 UNITY trial of its Vyvgart Hytrulo injection in Sjogren’s disease after an independent data monitoring committee concluded the study would not meet its pri…
    BioSpace · 13d agoNegative readoutNegative↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda recalls · 13d agoRegulatoryNegative↗ source
  • Newron reports five deaths in schizophrenia trial as FDA keeps hold on evenamide study
    Newron Pharmaceuticals disclosed that five participants have died in its late-stage schizophrenia trial, with four deaths among those receiving the investigational drug evenamide and one death amon…
    BioSpace · 13d agoRegulatoryNegative↗ source
  • Zealand Pharma’s petrelintide shows 9% weight loss in Phase 2 but fails to improve blood sugar, analysts unimpressed
    Zealand Pharma, in partnership with Roche, reported results from the Phase 2 ZUPREME-2 trial of petrelintide, a long‑acting human amylin analog, in 220 obese or overweight patients with type 2 diab…
    BioSpace · 13d agoNegative readoutNeutral↗ source