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  • Amgen discloses cybersecurity breach affecting patient data
    Amgen reported a cybersecurity incident that resulted in the exfiltration of protected patient health information and other proprietary data stored in cloud services managed by third‑party provider…
    BioSpace · 10d agoRegulatoryNegative↗ source
  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 10d agoRegulatoryNeutral↗ source
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  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 10d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 10d agoRegulatoryNeutral↗ source
  • BioNTech appoints Sobi's Guido Oelkers as new CEO, to start by Feb 1 2027
    BioNTech announced that Guido Oelkers, currently a leader at Swedish biotech company Sobi, will become its next chief executive officer. Oelkers is expected to take over the role no later than Feb…
    Endpoints · 10d agoNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 10d agoRegulatoryNeutral↗ source
  • HHS Secretary RFK Jr. defends Trump admin, critiques vaccine research while endorsing measles vaccine
    HHS Secretary Robert F. Kennedy Jr. gave an interview on August 3, 2026 in which he reiterated his support for the Trump administration and voiced criticism of current vaccine research practices.…
    Endpoints · 9d agoNeutral↗ source
  • Leo International Precision Health AG issues 3.77 million free shares to PC Beteiligungsgesellschaft mbH after capital increase
    Leo International Precision Health AG announced that its shareholder meeting on June 12, 2026 approved a capital increase funded from company reserves. As a result, the company will allocate 3,772…
    globenewswire health · 10d agoNeutral↗ source
  • Leo International Precision Health issues 3.77 million free shares to PC Beteiligungsgesellschaft after capital increase
    Leo International Precision Health AG announced that it will allocate 3,772,368 newly issued free shares to PC Beteiligungsgesellschaft mbH. The allocation follows a capital increase approved by t…
    globenewswire health · 10d agoDealNeutral↗ source
  • After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 10d agoNeutral↗ source
  • Nominations Open for 2026 Fiercest Women in Life Sciences, Deadline Sept 18
    Nominations are now open for the 2026 Fiercest Women in Life Sciences, an annual report that spotlights women making significant contributions across pharma, biotech, medtech, academia, venture cap…
    Fierce Biotech · 10d agoPositive↗ source
  • Leo International Precision Health allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG announced that Mr Leo Wang will receive an allocation of 78,844,000 bonus shares. The shares are issued from the company’s own funds as part of a capital incre…
    globenewswire health · 10d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft
    Leo International Precision Health AG announced that PC Beteiligungsgesellschaft mbH will receive 3,772,368 bonus shares. The allocation stems from a capital increase funded by the company’s own r…
    globenewswire health · 10d agoNeutral↗ source
  • Leo International Precision Health AG grants 78.8 million free shares to board member Leo Wang after capital increase
    Leo International Precision Health AG announced that Mr. Leo Wang, a member of its supervisory board, will receive 78,844,000 free shares. The allocation stems from a capital increase approved by…
    globenewswire health · 10d agoNeutral↗ source
  • Leo International Precision Health AG allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG disclosed that its board member Leo Wang will receive a large allocation of bonus shares. The allocation totals 78,844,000 shares, issued from the company’s o…
    globenewswire health · 10d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft following capital increase
    Leo International Precision Health AG announced the allocation of 3,772,368 bonus shares to PC Beteiligungsgesellschaft mbH. The allocation stems from a capital increase funded from the company’s o…
    globenewswire health · 10d agoRegulatoryNeutral↗ source
  • AstraZeneca and Bristol Myers Squibb reportedly in talks on a mega merger
    AstraZeneca is said to be discussing a possible merger with Bristol Myers Squibb, according to a Financial Times report published on Sunday. The combination would rank among the largest consolidat…
    Endpoints · 10d agoDealNeutral↗ source
  • Alnylam’s stock continues to fall as weekly roundup highlights Q2 earnings across biopharma
    The August 1 edition of Endpoints Weekly opens with a look at the latest biopharma earnings season. Alnylam Therapeutics is highlighted for a continued decline in its share price, reflecting ongoi…
    Endpoints · 12d agoEarningsNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 12d agoNegative readoutNegative↗ source
  • Novo Nordisk’s IL-6 drug ziltivekimab misses Phase 3 cardiovascular endpoint, shares drop 9%
    Novo Nordisk announced that its IL-6 inhibitor ziltivekimab did not meet the primary goal in a late-stage Phase 3 trial aimed at lowering major cardiovascular events. The ZEUS study enrolled patie…
    BioSpace · 12d agoNegative readoutNegative↗ source
  • Alnylam cuts TTR franchise guidance, market cap loses $10.8B as shares tumble 28%
    Alnylam announced a reduction in its full-year revenue outlook for its transthyretin (TTR) franchise, trimming the midpoint by $200 million. The company now projects TTR therapy sales of $4.2 bill…
    BioSpace · 12d agoEarningsNegative↗ source
  • Capricor CEO hints at possible lawsuit after FDA panel rejects Duchenne cardiomyopathy therapy
    An FDA Cellular, Tissue, and Gene Therapies advisory committee voted 9-3 against recommending Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy. The pane…
    BioSpace · 12d agoRegulatoryNegative↗ source
  • Eli Lilly and Resilience commit $750 million to expand U.S. KwikPen device capacity for diabetes and obesity treatments
    Eli Lilly and contract development and manufacturing organization Resilience have announced a $750 million investment to boost U.S. production of the KwikPen device that delivers Lilly’s injectable…
    BioSpace · 12d agoDealPositive↗ source
  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 12d agoNegative readoutNeutral↗ source
  • Madrigal spends $255 million on multiple MASH drug deals to complement Rezdiffra
    Madrigal Pharmaceuticals is expanding its MASH pipeline by acquiring several assets that could be used alongside its lead candidate, Rezdiffra. In early 2026 the company paid $50 million to Pfizer…
    Fierce Biotech · 13d agoDealPositive↗ source