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  • Asahi Kasei Therapeutics receives FDA approval for HSV drug acquired in $1 billion deal
    Asahi Kasei Therapeutics announced that the U.S. Food and Drug Administration granted approval for its herpes simplex virus (HSV) therapy. The drug, called Hovilpri, was purchased by Asahi Kasei e…
    Endpoints · 8d agoApprovalPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 9d agoRegulatoryPositive↗ source
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Nephrology634
  • 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
  • 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 · 8d 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 · 8d 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 · 8d agoPositive readoutNeutral↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 8d agoPositive readoutPositive↗ source
  • GSK allocates over $800 million to expand R&D and manufacturing hub in Pennsylvania
    GSK announced it will invest more than $800 million to expand its presence in Pennsylvania, marking its second expansion in the state within two years. The funds will be used to build a new resear…
    Endpoints · 8d agoDealPositive↗ 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 · 8d 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 · 8d agoDealPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 9d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 9d agoRegulatoryNeutral↗ 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
  • Undecimal Bio raises $18 million to expand siRNA platform beyond liver diseases
    Undecimal Bio, founded by Yaniv Erlich and Shaul Ilan, announced a new financing round that brings in $18 million. The capital will support the company’s effort to develop siRNA therapeutics for ta…
    Endpoints · 8d agoDealPositive↗ 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
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 9d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 9d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 9d agoNeutral↗ source
  • Merck's diabetic eye-disease drug hits primary goal but faces commercial doubts
    Merck announced results from a pivotal trial of its ophthalmology candidate remigromig, aimed at treating diabetic macular edema. The study achieved its primary endpoint, demonstrating that remigr…
    Endpoints · 8d agoNegative readoutNegative↗ source
  • Bausch + Lomb CEO Brent Saunders abruptly departs after failed multibillion-dollar sale
    Brent Saunders, known as a leading dealmaker and one of the highest-paid executives in biopharma, has left his role as chief executive of Bausch + Lomb. His departure ends a second stint as CEO of…
    Endpoints · 8d agoNegative↗ 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 · 8d agoNeutral↗ source
  • AstraZeneca attributes Phase 3 failure of bone disease enzyme therapy to trial design flaws
    AstraZeneca disclosed that its Phase 3 study of an enzyme replacement therapy for a rare genetic bone disorder did not meet its primary objectives. The company said the shortfall was largely due t…
    Endpoints · 9d agoNegative readoutNegative↗ source
  • Endpoints Weekly releases 2026 Women in Biopharma list of 20 honorees after reviewing 200 nominations
    Endpoints Weekly announced its annual Women in Biopharma 2026 project, highlighting leading women in the industry. The editorial team examined close to 200 nominations to select a shortlist. The…
    Endpoints · 10d agoPositive↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 10d ago↗ source