BioNTech and BMS Announce First Global Data for PD-L1xVEGF Bispecific in Small Cell Lung Cancer, Set Phase 3 Dose on September 08, 2025 BioNTech BNT327 Burning Mouth Syndrome Myers overall response rate PD-L1 PD-L1xVEGF Pharmacotherapy pumitamig Small cell carcinoma of lung squibb Vascular Endothelial Growth Factor A +
Servier Supercharges Neuro Pipeline with $450M Deal for Fragile X Syndrome Candidate on September 08, 2025 Acquisition Bioscience deal Fragile X Syndrome Infrequent Kaerus KER-0193 Orphan Drug Designation pediatric drug designation Phase 2 trial Servier +
FDA Shifts Approach on GLP-1 Compounding: Announces Consumer Green List Instead of Immediate Crackdown on September 08, 2025 Compound Consumer Safety drug shortages Glucagon-Like Peptide 1 green list import alert Regulation semaglutide United States Food and Drug Administration +
AstraZeneca Escalates EGFR Lung Cancer Rivalry with J&J: Tagrisso Combo Posts Survival Win on September 08, 2025 AstraZeneca Combined EGFR-mutated FLAURA2 trial Johnson & Johnson Lazcluze Malignant neoplasm of lung Non-Small Cell Lung Carcinoma Overall Survival Pharmacotherapy Rybrevant Tagrisso +
Daiichi and Merck's Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial on September 08, 2025 Antibody-Drug Conjugates CD276 gene Co. Daiichi deruxtecan IDeate-Lung01 ifinatamab Sankyo Small cell carcinoma of lung therapeutic autologous dendritic cells +
Rapport Reveals Promising Phase 2a Data for RAP-219 Epilepsy Pill, Plans Phase 3 Trials on September 08, 2025 anti-seizure medication clinical development drug-resistant epilepsy Epilepsy focal onset seizures RAP-219 Rapport Therapeutics Seizures +
Takeda’s Phase 3 Success Positions Oveporexton (TAK-861) as Potential First Mover in Multibillion-Dollar Narcolepsy Market on September 08, 2025 Clinical Trials multibillion-dollar market Narcolepsy type 1 oveporexton Phase 3 Standard of Care TAK-861 Takeda TPRG1L gene +
IQVIA Laboratories Bioinformatics Solutions Accelerate Genomic Insights for Drug Discovery in Partnership with NVIDIA on September 08, 2025 AI agents Aortic Valve Insufficiency Bio-Informatics Drug Discovery Enterprise Genome Genomics IQVIA NVIDIA Precision Medicine +
Junshi Biosciences Announces Phase 3 Win for IL-17A Drug JS005 in Psoriasis, Prepares China NDA Submission on September 08, 2025 Biosciences China clinical endpoints Drug Approval IL-17A monoclonal antibody JS005 Junshi Psoriasis +
Japan Wins Exemption for Generics in US-Japan Trade Deal on September 08, 2025 generic pharmaceuticals Japan semiconductor supply chains tariff exemption TNFRSF19 gene Transplant Registry Unified Management Program U.S. +
BioNTech and DualityBio Achieve Phase 3 Success with ADC Therapy for HER2-Positive Breast Cancer, Advancing Oncology Pipeline on September 08, 2025 Antibody-Drug Conjugates BioNTech DualityBio HER2-positive carcinoma of breast Market oncology pipeline pamirtecan Phase 3 Trial Progression-Free Survival trastuzumab +
RFK Jr. Blasts Pharma Industry and Spreads mRNA Vaccine Misinformation During Heated Senate Hearing on September 08, 2025 Centers for Disease Control and Prevention (U.S.) COVID19 (disease) Leadership mRNA misinformation Pharma Industry Policy public health medicine (field) RFK Jr. Senate hearing Vaccines +
Recent Developments in Logistical Coordination for Decentralized Clinical Trials (DCTs) on September 05, 2025 Clinical Trials decentralized Digital Trial Guidance 2024 Logistics platforms Preventive monitoring Remote supply chain management United States Food and Drug Administration +
MRM Health Nets $64M and Treeline Gathers $200M: Fierce Biotech Fundraising Tracker 2025 on September 05, 2025 Biocodex Biotech Fundraising Inflammatory Bowel Diseases LBP Live Biotherapeutic Product Microbiome therapeutics MRM Health Series B funding Treeline Ulcerative Colitis +
Survival Benefit of Amgen's Bemarituzumab in Gastric Cancer Attenuates at Final Analysis on September 05, 2025 Amgen Attenuated by (contextual qualifier) bemarituzumab Benefit final analysis FORTITUDE-101 FORTITUDE-102 Malignant neoplasm of stomach nivolumab Opdivo Overall Survival Zai Lab +
FDA Pushes Back Agios' Pyrukynd Thalassemia Decision to December on September 05, 2025 Agios decision delay Liver damage PDUFA PYRUKYND REMS Thalassemia United States Food and Drug Administration +
Atlas Venture Raises $400M Opportunity Fund to Bolster Biotech Portfolio on September 05, 2025 Biopharma biotech startups Cervical Atlas Investments Late stage M growth fund Opportunity Fund III portfolio support venture +
FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure on September 05, 2025 Complete CRLs Drug Approval real-time publishing regulatory disclosure Response Letters Translucent United States Food and Drug Administration +
Enveda Raises $150M Series D, Advances Nature-Inspired Drug Programs on September 05, 2025 Biosciences Dermatitis, Atopic Enveda Immune System Diseases Investments Mikael nature-inspired drug discovery Series D +
RFK Jr. Faces Bipartisan Senate Criticism After CDC Shakeup on September 05, 2025 bipartisan criticism Centers for Disease Control and Prevention (U.S.) director firing Policy public health medicine (field) RFK Jr. Senate hearing Shakeup Trump administration reforms Vaccines +
RFK Jr. Fires Top Deputies, Reshuffles Leadership at HHS on September 05, 2025 Buckham Changing chief of Hannah Anderson Health Heather Flick Melanson Leadership Research Personnel reshuffle Robert F. Kennedy Jr. Social Welfare Staff TMEM79 gene Trump loyalists +
Wave RNA Editing Restores Enzyme in Genetic Disorder but Fails to Impress Investors on September 04, 2025 alpha 1-Antitrypsin Deficiency Clinical Trials enzyme restoration Investor Reaction RNA Editing Wave Life Sciences WVE-006 +
Sanofi Phase 3 Eczema Win Falls Short of Analyst Expectations on September 04, 2025 Amlitelimab Dermatitis, Atopic Dupixent EASI-75 Eczema Expectations Market Reaction sanofi +
AC Immune Narrows Pipeline and Cuts 30% Workforce to Extend Cash Runway on September 04, 2025 Actinium Alzheimer 's disease cash runway Immune late-stage assets layoffs Parkinson Disease pipeline reduction +
AstraZeneca Ends Manufacturing License at Indian Plant and Exits Site as Part of Global Strategy on September 04, 2025 AstraZeneca Bangalore plant Contract agreement Drug Industry global strategy India manufacturing manufacturing license Site of exit +
Endpoints News to Announce 2025 'Endpoints 11' Biotechs to Watch Live in Boston on September 04, 2025 Biopharma biotech startups City of Boston Endpoints Industry innovation live event trends qualifier +
FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER on September 04, 2025 Accelerated Approved CBER CDER gene therapy Hereditary Diseases Infrequent RDEP regulatory guidance submission program United States Food and Drug Administration +
Wave Life Sciences Shares Dip After Mixed Data Update on GSK-Partnered AATD Therapy on September 04, 2025 alpha 1-Antitrypsin Deficiency Clinical Trials protein levels RNA Editing SmithKline Beecham Wave Life Sciences WVE-006 +
Gilead Unveils New Manufacturing Site in California as Part of $32B U.S. Investment Plan on September 04, 2025 Billion Biological Factors California economic impact expansion Foster City Gilead Sciences Investments manufacturing Manufacturing Facilities R&D Surgical construction United States +
FDA Announces New Rare Disease Approval Programme on September 04, 2025 Accelerated Approved Biological Factors conditional approval pathway drug review Endpoints Infrequent real-world data streamlined process Surrogate United States Food and Drug Administration +
Novartis Again Partners with Argo Biopharma in $5.2B+ RNAi Cardiovascular Deal on September 04, 2025 ANGPTL3 Biopharma biotech collaboration cardiovascular pipeline Drug Development Dyslipidemias milestone payments Novartis RNA Interference RNA, Small Interfering +
Treeline Announces $200M Funding Boost, Moves Three Cancer Drugs into Clinic on September 04, 2025 BCL6 gene cancer drugs Clinical Trials Degrader EZH2 protein, human Funding Inhibitor K-ras Oncogene Lymphoma Series Solid Neoplasm TLN-121 TLN-254 TLN-372 Treeline +
UK Pharma Trade Group Calls for Overhaul of Government’s Life Sciences Investment Evaluation and Medicines Pricing Schemes on September 03, 2025 ABPI Biological Science Disciplines Evaluation government review innovation Investments Nance-Horan syndrome pharma trade group Pricing statutory scheme UK valproic acid glucuronide +
Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel on September 03, 2025 Advisory Committees CHARGE Syndrome Paul Offit Policy removal technique RFK Jr. United States Food and Drug Administration vaccine panel Vaccines VRBPAC +
How Past Endpoints 11 Winners Fared During the 2025 Biotech Downturn on September 03, 2025 2025 biotech downturn Endpoints Industry trends qualifier winners +
Recent News on Scaling Up Cell & Gene Therapy Supply Chains (2025) on September 03, 2025 Automation Cells digital solutions gene therapy Growth Logistics Market patient-specific therapies risk mitigation scalability supply chain white glove delivery +
Merck’s Oral PCSK9 Inhibitor Enlicitide Decanoate Achieves Third Consecutive Phase 3 Success on September 03, 2025 Administration of prophylactic statin Clinical Trials CORALreef Lipids enlicitide decanoate Hypercholesterolemia LDL Cholesterol Lipoproteins Merck Oral cavity oral PCSK9 PCSK9 inhibitor +
Amgen to Invest Over $600M in New Innovation Centre at California Headquarters on September 03, 2025 Amgen Automation Biotechnology California Capital Construction worker digital tools ELAVL2 gene Incentives innovation innovation centre Investments Science therapeutic development Thousand Oaks +
Ionis Builds Case for Wider Tryngolza Use in Severe Lipid Disorders Following Positive Phase 3 Results on September 03, 2025 Familial chylomicronemia syndrome Hypertriglyceridemia Ionis Pharmaceuticals Lipid Metabolism Disorders Olezarsen Pancreatitis, Acute Severe (severity modifier) Tryngolza +
Editas Medicine Reboots With Cholesterol Gene Therapy (EDIT-401) as Lead Asset on September 03, 2025 clinical development EDIT-401 Editas Medicine Gene Modification gene therapy Hyperlipidemia in vivo LDL Cholesterol Lipoproteins LDLR gene strategic pivot +