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Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025
Biosimilars
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
UK pharma major AstraZeneca has scrapped its plans to invest £450 million in expanding ($559 million) to expand its vaccine plant in Speke, Liverpool, blaming a reduction in government support. 1 February 2025
Pharmaceutical
Evaxion Biotech has priced a public offering, seeking to raise $10.8 million before expenses, with closing anticipated tomorrow. 30 January 2025
Pharmaceutical
hVIVO, a fast-growing early-stage German contract research organization (CRO) has acquired two clinical research units from Clinical Research Services (CRS), in Mannheim and Kiel, Germany, for a total of 10 million euros ($10.5 million). 29 January 2025
Pharmaceutical
US biotech Wayfinder Biosciences has entered a research collaboration with Japanese drugmaker Daiichi Sankyo to develop small molecule therapies targeting RNA in neurodegenerative diseases. 16 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biotechnology
US biotech Myeloid Therapeutics has restructured its operations to concentrate on two cancer programs already in the clinic, a move that has resulted in staff reductions and an uncertain future for its early-stage research work. 16 April 2025
Biotechnology
Californian biotech Glycomine has raised $115 million in a Series C financing to advance its lead candidate, GLM101, into a Phase IIb trial. 16 April 2025
Pharmaceutical
Italian pharma major Recordati today announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. 16 April 2025
Pharmaceutical
French drugmaker Ipsen today presented sales for the first quarter of 2025. The company did not release any earnings figures. 16 April 2025
Biotechnology
US mRNA specialist Moderna (Nasdaq: MRNA) has announced that its manufacturing facility in the UK has been granted a manufacturer’s license by the Medicines and Healthcare products Regulatory Agency (MHRA). 16 April 2025
Pharmaceutical
UK pharm major GSK has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in the pharmaceutical industry, the trade group’s Prescription Medicines Code of Practice Authority (PMCPA) has revealed. 16 April 2025
Pharmaceutical
US President Donald Trump has passed an executive order that answers the pharmaceutical industry’s calls for the scrapping of the Inflation Reduction Act’s (IRA) ‘pill penalty’. 16 April 2025
Biotechnology
US biotech Mural Oncology has halted all development of its lead candidate, nemvaleukin alfa, after the engineered cytokine failed to meet the primary endpoint in a Phase II melanoma trial — just weeks after a similar failure in ovarian cancer. The company now plans to explore strategic alternatives, including a potential sale. 16 April 2025
Pharmaceutical
Dutch specialty pharma firm Norgine Pharmaceuticals has entered into a definitive agreement to acquire Theravia, a French pharmaceutical company specializing in cutting-edge treatments for patients with rare and debilitating conditions from Mérieux Equity Partners. 16 April 2025
Biotechnology
The European Commission (EC) has at last granted the amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) Marketing Authorization (MA) in the European Union (EU). 16 April 2025
Biosimilars
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China, making it the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody cleared for TED by the National Medical Products Administration (NMPA). 16 April 2025
Biotechnology
Galapagos said on Tuesday that its chief financial officer and chief operating officer Thad Huston will leave the company on August 1, 2025, to return to the USA for personal and professional reasons. 15 April 2025
Pharmaceutical
German biotech HepaRegeniX has raised 21.5 million euros ($23 million) in new funding to support the clinical development of its lead candidate, HRX-215, a first-in-class treatment aimed at enhancing liver regeneration. 15 April 2025
Pharmaceutical
Danish pharma major Novo Nordisk says that it has become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside its authorized supply chain in the USA. 15 April 2025
Pharmaceutical
Cambridge, USA-based biotech Oak Hill Bio, which is focused on acquiring and developing life-changing rare disease therapeutics, has entered into an exclusive license agreement with Roche to obtain global rights for rugonersen (RO7248824). 15 April 2025
Pharmaceutical
Shares in Johnson & Johnson were 1% lower in the early stages of Tuesday’s trading after the US health conglomerate presented its first-quarter 2025 financial results. 15 April 2025
Biotechnology
Privately-held US biotech Attovia Therapeutics, which is developing treatments for immune-mediated diseases with high unmet patient need, today announced the close of a $90 million Series C financing. 15 April 2025
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