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Gut Microbiome’s Role in Vascular Aging Explored
Research led by cardiologist Jürg Beer at the University of Zürich highlights the impact of aging gut microbiomes on vascular senescence. Elevated microbial metabolites phenylacetic acid (PAA) and...
FDA’s Complete Response Letters Transparency: Impact and Limitations
The U.S. Food and Drug Administration has initiated a policy shift by publicly releasing over 200 complete response letters (CRLs) issued between 2020 and 2024 for drugs that were eventually...
Capricor’s Duchenne Muscular Dystrophy Therapy Faces Regulatory Setback
Capricor Therapeutics has received a complete response letter from the U.S. FDA rejecting its biologics license application for deramiocel, an allogeneic cardiosphere-derived cell therapy intended...
Biopharma Mergers and Acquisitions Surge With Merck's $10B Verona Purchase
Biopharma dealmaking reached a high point in June 2025, with total transaction value hitting $35.07 billion, marking the strongest month of the year. Among significant deals, Merck & Co. acquired...
Radiopharmaceutical Startups Secure Major Venture Funding
Radiopharmaceutical developers Actithera and Nuclidium have attracted significant venture capital investments to advance clinical and manufacturing capabilities. Actithera closed a $75.5 million...
Advances in AI for Protein Dynamics and Small-Molecule Function Prediction
New AI-based tools are accelerating drug discovery and protein research by modeling complex biological processes with enhanced speed and accuracy. Microsoft Research unveiled BioEmu, a generative...
Advances in Genomics and Cancer Detection Technologies
Emerging genomic and diagnostic technologies seek to improve early detection and monitoring of cancers. Personalis and Tempus AI expanded their collaboration to include colorectal cancer,...
Biomanufacturing Faces Looming Talent Shortage by 2028
The biomanufacturing industry is approaching a critical talent deficit projected around 2028, driven by growing demand for specialized skills outpacing supply. Jason Beckwith, PhD, of Merrill...
FDA Approvals and Regulatory Developments in July 2025
July 2025 has seen robust FDA approval activity with at least eight products awaiting decisions and multiple new drug entities (NMEs) approved in June, raising the 2025 tally to 19. Highlights...
Innovations in RNA and Allergy Therapeutics
Cutting-edge RNA and antibody therapies are emerging to address cardiovascular and allergic diseases. Shanghai Circode Biomed has advanced HM-2002, a circular RNA-based drug candidate for ischemic...
Leadership Changes Amid Biotech Industry Transitions
Jazz Pharmaceuticals appointed current COO Renée Galá as incoming CEO, succeeding co-founder Bruce Cozadd effective August 2025, signaling continuity amid operational shifts. Karyopharm...
FDA Publishes Drug Rejection Letters: A Push for Transparency
The FDA has publicly released an initial batch of over 200 Complete Response Letters (CRLs) from 2020 to 2024, marking a significant policy shift aimed at increasing transparency in drug approval...
Merck’s $10B Bet on Verona Pharma and COPD Drug Ohtuvayre
Merck completed a $10 billion acquisition of Verona Pharma to strengthen its cardiorespiratory portfolio with Ohtuvayre, a selective dual inhibitor targeting PDE3 and PDE4 enzymes, intended as a...
AI-Driven Advances in Protein Modeling and Virtual Cell Systems
New AI models revolutionize understanding of protein dynamics and cellular gene networks, enhancing drug discovery and disease research. Microsoft Research developed BioEmu, a generative deep...
Capricor’s Cell Therapy CRL Marks Regulatory Setback in Duchenne Muscular Dystrophy
Capricor Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its deramiocel cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The agency...
Biopharma Funding and Dealmaking Trends in 2025
Biopharma dealmaking hit a record $35 billion in June 2025, marking the highest monthly total of the year and bolstering H1 figures to $138 billion, surpassing full-year totals from pre-2020...
AbbVie’s $700M Acquisition of IGI’s Trispecific Antibody for Multiple Myeloma
AbbVie secured exclusive rights to IGI Therapeutics’ early-stage trispecific antibody ISB-2001 targeting BCMA, CD38, and CD3 for multiple myeloma and autoimmune indications in a $700 million...
Novel Technologies Accelerate Disease Detection and Research
Innovative tools and diagnostic platforms are advancing early disease detection and research capabilities. Scripps Research scientists developed a microchip that rapidly maps antibody-virus...
Biotech Workforce Challenges and Talent Retention
The biomanufacturing industry faces an impending 'talent singularity' by 2028, where the demand for uniquely skilled workers will exceed supply due to evolving technological needs. Jason Beckwith...
FDA Approvals and Regulatory Developments in July 2025
The FDA started July strongly with multiple approvals and pending decisions. Three new molecular entities (NMEs) were approved in June, bringing the yearly total to 19 with additional approvals...