The Indian subsidiary of UK pharma major AstraZeneca has announced a Central Drugs Standard Control Organization (CDSCO) approval to import for sale and distribution of trastuzumab deruxtecan concentrate for solution for infusion 100mg for an additional indication, according to a Healthcare Radius report. 12 May 2025
Sweden’s immune-oncology firm Alligator Bioscience today announced the successful completion of the manufacture of the first GMP drug product batch of its lead asset mitazalimab using a new improved commercial-scale manufacturing process. 9 May 2025
Opella today becomes an independent global leader in consumer healthcare, marking a pivotal step in French pharma major Sanofi's strategy. 30 April 2025
Following the negative results of the COAST Phase III trial announced on 24 March, Australia-based Opthea announced has updated on its clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and accelerated top-line results from its second Phase III trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD. 31 March 2025
The Center for Biologics Evaluation and Research (CBER), part of the US Food and Drug Administration, saw its top vaccine official pushed out of the post on Friday, according to people familiar with the matter, according to a Wall Street report. 29 March 2025
Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025
Japanese drugmaker Kyowa Kirin and Swiss generics and biosimilars giant Sandoz have won approval for the partial change of their rituximab biosimilar for the treatment of refractory nephrotic syndrome (frequently relapsing or steroid-dependent). 7 March 2025
Swiss pharma giant Roche has announced the launch of the Roche Genentech Innovation Center Boston, USA, at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning. 7 March 2025
US cell and gene therapy specialist Mustang Bio has announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts, and concurrent divestment of certain fixed assets including furniture and equipment to an AbbVie unit for $1.0 million. 3 March 2025
US health officials are reportedly reexamining a $590 million agreement awarded to Moderna for the development of its bird flu vaccine, according to sources cited by Bloomberg. The review is part of a broader government effort to scrutinize spending on mRNA-based vaccines, the technology behind Moderna’s COVID-19 shot. 28 February 2025
Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025
Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025
Further to the announcement on January 2, 2025 on the potential combination of UK-listed Poolbeg Pharma and Austria’s HOOKIPA Pharma, the board of Poolbeg announced that it was informed yesterday that HOOKIPA has terminated discussions on the proposed combination of the two companies. 21 February 2025
Reacting to press reports, Germany’s Merck KGaA has confirmed it is in advanced discussions with SpringWorks Therapeutics with the aim of acquiring the US biotechnology company. 11 February 2025
Kite, a Gilead Sciences company, will share four posters that add to the growing body of evidence to support the clinical use of its chimeric antigen receptor (CAR) T-cell therapy portfolio, at the 7th European CAR T-cell Meeting, 6-8 February 2025, Strasbourg, France. 8 February 2025
US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025
Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union. 3 February 2025
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
German drugmaker Grünenthal has named Maren Thurow as its new vice president and head of global communications, stepping into the role at a time of significant business expansion and leadership change. She succeeds Florian Dieckmann, who had led the company’s communications function since 2021. 20 May 2025
Australia’s digital health sector is poised for steady expansion, with the market forecast to grow at a compound annual growth rate of around 8% through 2034, according to research from data and analytics group GlobalData. 20 May 2025
Cambridge, USA-based Apnimed today announced positive top-line results from its pivotal Phase III SynAIRgy clinical trial evaluating the efficacy and safety of its lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. 20 May 2025
German vaccine pioneer BioNTech today revealed that its UK subsidiary has signed a grant agreement with the UK government to broaden the company’s R&D activities for innovative medicines in the UK. 20 May 2025
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma. 20 May 2025
Anti–interleukin five (IL-5) biologics such as mepolizumab and benralizumab have shown significant efficacy in reducing moderate and severe exacerbations in both asthma and chronic obstructive pulmonary disease (COPD), according to new real-world data presented at the 2025 American Thoracic Society (ATS) International Conference. 20 May 2025
US pharma major Pfizer is stepping up its presence in the high-stakes field of bispecific immuno-oncology with a licensing deal worth up to $6 billion for a Chinese-developed drug that targets two key cancer pathways. 20 May 2025
Major progress has been made in delivering a more efficient and adaptable regulatory framework for clinical trials, and Lawrence Tallon, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reflected on International Clinical Trials Day. 20 May 2025
German drugmaker Boehringer Ingelheim has released full Phase III results for its experimental lung disease drug nerandomilast, showing it met primary endpoints in both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
However, while the data were enough to support regulatory filings, analysts remain cautious, viewing the treatment as a marginal improvement over current options. 20 May 2025
Swiss gene-editing specialist CRISPR Therapeutics and San Diego, USA-based Sirius Therapeutics, which is developing innovative small interfering RNA (siRNA) therapies, announced a strategic partnership to develop and commercialize siRNA therapies. 20 May 2025
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
A US district court judge has found that the Department of Health and Human Services (HHS) must preapprove the use of 340B rebate models before they can be implemented. 19 May 2025
US human genetics biotech 23andMe today revealed it has entered into a definitive agreement for the sale of the company to Regeneron Pharmaceutical, whose shares climbed 2% following the announcement 19 May 2025