The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three biosimilars for approval at its March 2025 meeting. 28 March 2025
Cardiovascular-focused Milestone Pharmaceuticals was trading more than 60% lower early in trading on Friday, with its share price worth less than $0.90. 28 March 2025
Danish pharma major Novo Nordisk has taken another step in its strategy to maintain dominance in the obesity space by adding complementary mechanisms to pair with its blockbuster bGLP-1 franchise. 28 March 2025
Japan’s Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. 28 March 2025
German life sciences and pharma company Merck KGaA today revealed it has exercised its option with China’s Abbisko Therapeutics for commercialization of pimicotinib in the US and rest of world. 28 March 2025
Singaporean biotech Shanton Pharma has reported positive top-line results from a Phase IIb clinical trial of its investigational gout therapy SAP-001 in patients with refractory disease, a group that often fails to respond to existing oral treatments. 28 March 2025
US genomics firm Galatea Bio has raised $25 million in funding to expand its global biobank and accelerate the development of AI-powered tools for drug discovery and disease risk prediction, with a particular focus on populations historically left out of genomic research. 28 March 2025
The interleukin-2 (IL-2) therapies market in the USA is poised for major growth, projected to reach $4 billion by 2034, according to research from DelveInsight. 28 March 2025
Italian biopharma Chiesi Group has announced a major investment in Nerviano, near Milan, with the building of a new facility for the production of its therapeutic solutions. 28 March 2025
Germany-headquartered CureVac late Thursday announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. 28 March 2025
US pharma major Merck & Co has shared the first results from a late-stage trial of a subcutaneous version of its blockbuster immunotherapy Keytruda (pembrolizumab), with data presented Thursday at the European Lung Cancer Congress. 28 March 2025
US clinical stage biopharma Candel Therapeutics has announced final survival data from a Phase IIa clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment. 28 March 2025
German drugmaker Bayer has signed a global licensing agreement with China-based Puhe BioPharma, gaining exclusive rights to develop and commercialize an early-stage precision oncology therapy targeting MTAP-deleted tumors. 27 March 2025
Danish cancer specialist Genmab today announced that the Japanese Ministry of Health, Labor and Welfare has approved Tivdak (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. 27 March 2025
Cambridge, USA-based RNS specialist Wave Life Sciences has announced positive data from the Phase II FORWARD-53 trial of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. 27 March 2025
Genetic diseases company BridgeBio Pharma has announced that the Japanese Ministry of Health, Labor and Welfare has approved acoramidis, under the brand name Beyonttra, for the treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). 27 March 2025
UK-based specialty pharma Kelso Pharma, which is backed by private equity investor Apposite Capital, announced that it has secured over £140 million ($180 million) of acquisition funding. 27 March 2025
US biotech Equillium reported Thursday that its lead drug candidate itolizumab failed to meet the main objective in a Phase III trial for patients with acute graft-versus-host disease, sending shares tumbling in pre-market trading. 27 March 2025
The US Senate has confirmed President Donald Trump’s nominees to lead two of the country’s top health agencies, approving surgeon Marty Makary as Commissioner of the Food and Drug Administration and economist and physician Jay Bhattacharya as director of the National Institutes of Health. 27 March 2025
Swiss ophthalmic drug company Alcon today announced it has acquired a majority interest in Aurion Biotech, a privately-held US clinical-stage company developing advanced cell therapies to treat eye diseases. 27 March 2025
San Francisco-based epigenetic editing company Epicrispr Biotechnologies has secured $68 million in the first close of its Series B financing. 27 March 2025
German family-owned pain specialist Grünenthal today published its 2024 financial results, marking a year of impressive resilience, strategic growth and operational excellence. 27 March 2025
The US Biotechnology Innovation Organization (BIO) has released results from a membership survey that underscores the significant, global integration of the biomedical supply chain. 27 March 2025
The Trump administration plans to pull US funding from Gavi, the global vaccine alliance that helps deliver immunizations to children in lower-income countries, according to internal documents obtained by the New York Times. 26 March 2025
US biotech Exelixis has secured a sixth indication for its cancer drug Cabometyx (cabozantinib), following a green light from the Food and Drug Administration for advanced neuroendocrine tumors (NET). 26 March 2025
French independent pharma major Servier is ramping up its industrial development with the inauguration of a new production unit for the active ingredient of one of its venous medicines. 26 March 2025
The Chinese government is contemplating a new drug reimbursement category called category C to make commercial insurance companies a major payer. If the new category is introduced, it is expected to significantly accelerate China’s innovation, said speakers at the BIOCHINA event held in Suzhou. 26 March 2025
US pharma giant Merck & Co today announced that the European Commission (EC) has approved Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for a new indication, marking the fourth nod for the product from the regulator. 26 March 2025
Spain-based drugmaker REIG JOFRE has signed a commercial agreement with LEO Pharma, a privately-held Danish firm specializing in medical dermatology and thrombosis. 26 March 2025
Pharma major GSK on Tuesday said its urinary tract infection treatment gepotidacin, under the brand name Blujepa, has been approved in the USA. 26 March 2025
Polygenic diseases company Character Biosciences has announced an oversubscribed $93 million Series B financing round to accelerate the advancement of its pipeline of precision therapies to treat degenerative eye diseases, starting with age-related macular degeneration (AMD). 26 March 2025
The global central nervous system (CNS) market is projected grow to over $80 billion in sales in 2025 for the first time since 2013, making a significant resurgence after a decade of stagnation. 26 March 2025
Theratechnologies has received approval from the US Food and Drug Administration for Egrifta WR (tesamorelin), a new formulation for injection. The treatment is indicated for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. 26 March 2025
US biotech Cassava Sciences will shut down development of its lead Alzheimer’s disease candidate, simufilam, after the treatment failed a second late-stage trial. 26 March 2025
Asgard Therapeutics, a privately-held biotech working in in vivo direct cell reprogramming for cancer immunotherapy, has named experienced immunology drug development specialist Shane Olwill its chief development officer (CDO). 26 March 2025