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 Food and Drug Administration (FDA) has approved Swiss pharma giant Novartis’ oral Fabhalta (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition and the third US indication for the drug. 21 March 2025
US biotech Rhythm Pharmaceuticals has reacquired the rights to its obesity treatment Imcivree (setmelanotide) in China, including Hong Kong and Macau, after terminating a 2021 licensing agreement with China-based RareStone Group. 21 March 2025
US RNAi therapeutics company Alnylam Pharmaceuticals announced the US Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, Amvuttra (vutrisiran). 21 March 2025
US biotech GRO Biosciences is weighing the way forward for its lead gout program following a quiet restructuring that saw a reduction in research staff and key leadership changes. 21 March 2025
Japanese ophthalmology company Santen Pharmaceutical announced that it will launch Ryjusea Mini solution 0.025% (tropine sulfate hydrate) on April 21, 2025. 21 March 2025
US pharma major Johnson & Johnson has won US approval for Tremfya (guselkumab) in the treatment of adults with moderately to severely active Crohn’s disease, further expanding the immunology drug’s footprint and reinforcing the company’s efforts to replace revenue from declining Stelara (ustekinumab) sales. 21 March 2025
Akari Therapeutics, a US biotech developing next-generation bi-functional antibody drug conjugates (ADCs) for the treatment of cancer, has announced the appointment of Abizer Gaslightwala as president and chief executive. 20 March 2025
Today, Cambridge, USA-based clinical-stage oncology company Immuneering announced the appointment of Dr Igor Matushansky as chief medical officer (CMO). 20 March 2025
Elevation Oncology has decided to discontinue development of EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC) which was being developed for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers. 20 March 2025
Privately-held drugmaker Paratek Pharmaceuticals is to buy specialty pharma Optinose, including its approved product Xhance (fluticasone propionate). 20 March 2025
US neuroscience-focused biopharma Neurocrine Biosciences today presented new data from the long-term, open-label KINECT 4 study demonstrating remission of tardive dyskinesia among the majority of patients treated with once-daily Ingrezza (valbenazine) capsules. 20 March 2025
Chugai Pharmaceutical has launched Lunsumio (mosunetuzumab) in Japan for patients with relapsed or refractory follicular lymphoma who have undergone at least two prior standard therapies. 20 March 2025
Pharmaceutical leaders are warning that the UK is becoming an unattractive destination for investment due to high and unpredictable levies on medicine sales. 20 March 2025
Chimeric antigen receptor T-cell (CAR-T) therapeutics have emerged as a dominating cancer treatment within cell and gene therapies (CGT). 20 March 2025
US gene therapy company Regenxbio has reported new, positive interim data from two additional patients in the Phase I/II portion of the AFFINITY DUCHENNE trial of RGX-202, an investigational gene therapy for Duchenne muscular dystrophy (DMD). 20 March 2025
French pharma major Sanofi today revealed it has entered into a definitive agreement with privately-held US biotech Dren Bio, to acquire the latter’s DR-0201, a targeted bispecific myeloid cell engager (MCE) that has shown robust B-cell depletion in pre-clinical and early clinical studies. 20 March 2025
The Indian subsidiary of US pharma major Eli Lilly (NYSE: LLY) has announced the launch of Mounjaro (tirzepatide) in single-dose vial presentation. This follows the marketing authorization from the Central Drugs Standard Control Organization (CDSCO). 20 March 2025
Japanese drugmaker Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been launched in the company’s home country for the treatment of adults with hormone receptor (HR) positive, HER2 negative, unresectable or recurrent breast cancer after prior chemotherapy. 20 March 2025
Purdue Pharma has filed a Chapter 11 Plan of Reorganization and related disclosure statement with the US Bankruptcy Court for the Southern District of New York. 20 March 2025
The US Food and Drug Administration (FDA) has granted traditional approval to Merck & Co’s Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). 20 March 2025