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  • Webinar Explores Manufacturing Risks and Partner Strategies for the Next Five Years
    The webinar titled "Manufacturing in Turbulent Times" is scheduled for September 17, 2026 and is designed to help biopharma sponsors understand the manufacturing challenges that lie ahead. It note…
    BioSpace · 1mo agoNeutral↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
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Biotech hedge fund launches North Immunology to develop long-acting antibody for atopic dermatitis
STAT+ hedge fund is creating a new immunology company called North Immunology with the goal of delivering a better, long-acting antibody therapy for atopic dermatitis. The concept originated two y…
STAT · 1mo agoPositive↗ source
  • FDA hiring drive to add 2,000 staff stalls due to overwhelmed HR center
    The Food and Drug Administration says it plans to bring on more than 2,000 new employees, a move aimed at rebuilding staff after the 2025 cuts that eliminated about 3,500 positions. Agency officia…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Kennedy appoints eight specialists to U.S. Preventive Services Task Force, ending year-long vacancy
    Health secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, filling vacancies after the panel had not met for more than a year. The appointees in…
    STAT · 1mo agoNeutral↗ source
  • Startup launches trial of psychedelic-style drug for Parkinson’s symptom
    A new biotech startup announced it will begin preclinical testing of a psychedelic-like compound aimed at alleviating a specific symptom of Parkinson’s disease. The company plans to evaluate the d…
    STAT · 1mo agoNeutral↗ source
  • Shift away from oppositional defiant disorder reflects changing views on child noncompliance
    Lawrence Diller, a behavioral pediatrician, writes about a noticeable shift in how clinicians label children who resist authority. He recounts a recent call from a mother who asked whether her son…
    STAT · 1mo agoNeutral↗ source
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Definium shares new psychedelics data and court reprieve for international researchers discussed on The Readout LOUD
    The latest episode of STAT's "The Readout LOUD" podcast covered two timely topics: Definium's recently released psychedelics data and a court decision that gave international scientists a brief leg…
    STAT · 1mo agoNeutral↗ source
  • FDA hiring delays persist despite expectations, and Bavarian Nordic names new CEO
    The recent discussion about a hiring surge at the U.S. Food and Drug Administration following last year’s DOGE budget cuts has not materialized as expected. Industry observers had anticipated a rap…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts discuss wet AMD treatment limits and need for longer lasting therapies
    In a recent episode of the Denatured podcast, Professor Philip Jacob Rosenfeld of the University of Miami and Wesley Jackson, chief science officer at Valitor, joined host Jennifer C. Smith-Parker…
    BioSpace · 1mo agoNeutral↗ source
  • Over 15,000 Science/R&D jobs and 10,800 Clinical roles posted on BioSpace in first eight months of 2026
    BioSpace data shows seven biopharma disciplines each had at least 5,000 live postings during the first eight months of 2026. Science/R&D leads with 15,361 positions, ranging from manager roles at…
    BioSpace · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Health Secretary RFK Jr. delivers anti‑vaccine keynote at Children’s Health Defense conference
    Robert F. Kennedy Jr., the U.S. health secretary, opened the Children’s Health Defense conference with a keynote that focused on his criticism of vaccines. The speech revisited his broader health…
    STAT · 1mo agoNegative↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Zocdoc adds chatbot scheduling and updates on Medicare ACCESS
    Zocdoc announced that its platform now lets users book medical appointments directly through chatbots and health‑plan websites. The new integration means patients can schedule visits without leavi…
    STAT · 1mo agoNeutral↗ source
  • Health secretary Kennedy launches program to accelerate autism diagnosis
    U.S. health secretary Robert F. Kennedy Jr. announced a new initiative aimed at speeding up autism assessments during a keynote at a Children’s Health Defense conference. He said the existing diag…
    STAT · 1mo agoPositive↗ source
  • STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease
    The FDA approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s.
    STAT · 1mo ago↗ source
  • Novartis drops $125M for Sironax’s tech to cross blood-brain barrier
    Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
    BioSpace · 1mo ago↗ source
  • Psychedelic therapeutics near first FDA approval as Compass Pathways and Definium report promising results
    BioSpace notes that the psychedelic drug sector is regaining momentum after a setback in 2024 when Lykos’ MDMA therapy failed to win FDA clearance. The focus has shifted to new candidates, with Com…
    BioSpace · 1mo agoRegulatoryPositive↗ source