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Biotechnology
Contract development and manufacturing organization (CDMO) Rentschler Biopharma has hired Benedikt von Braunmuehl as chief executive officer. 19 September 2023
Pharmaceutical
Germany’s Atriva Therapeutics and Canadian firm Biocure Technologies have entered into an exclusive letter agreement for a reverse takeover transaction. 18 September 2023
Pharmaceutical
Swiss contract development and manufacturing organization (CDMO) Lonza announced today that its chief executive, Pierre-Alain Ruffieux, will leave the company at the end of September by mutual agreement. 18 September 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended that the conditional marketing authorization for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma, should not be renewed. 16 September 2023
Biotechnology
Japanese drugmaker Astellas Pharma is planning to build a new $350 million manufacturing facility in Tralee, Ireland, adding to existing capacity and capabilities for aseptic drug products. 15 September 2023
Biotechnology
Jonathan Milner, the founder and one of the largest investors in Abcam with a holding of more than 6%, has announced his decision to vote against the proposed acquisition of the company by Danaher. 14 September 2023
Pharmaceutical
Final guidance from the UK’s health technology assessor recommends that the country’s national healthcare provider fund Jakavi (ruxolitinib) in polycythaemia vera (PV). 14 September 2023
Biotechnology
Japanese contract development and manufacturing organization FUJIFILM Diosynth Biotechnologies today announced the successful completion of a new facility in Darlington, UK, which is now cGMP operational for manufacturing of viral gene therapies, oncolytic viruses and viral vaccines for clinical trials. 14 September 2023
Pharmaceutical
British nephrology start-up Mironid has extended its series A financing round, bringing the total amount raised to $44 million. 13 September 2023
Biotechnology
Belgian neuromuscular and neurodegenerative disorder specialist Augustine Therapeutics has made several executive appointments, including a new chief medical officer. 12 September 2023
Generics
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation. 9 September 2023
Pharmaceutical
The Johnson & Johnson subsidiary Janssen has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally-advanced or metastatic urothelial cancer with susceptible pan-fibroblast growth factor receptor (FGFR) alterations. 8 September 2023
Biotechnology
British start-up Myricx Bio, a spin out from Imperial College and the Francis Crick Institute, has inked an antibody license agreement with China’s Biocytogen Pharmaceuticals. 8 September 2023
Pharmaceutical
Cardiology specialist Corteria Pharmaceuticals has raised $71 million in a series A financing co-led by American investor OrbiMed and EU-based Jeito Capital. 7 September 2023
Biotechnology
Canada’s Sernova has appointed a new chief executive, Cynthia Pussinen, replacing Philip Toleikis, who will take over as chief technology officer. 6 September 2023
Pharmaceutical
Women’s health company Organon has appointed Juan Camilo Arjona Ferreira as chief medical officer and Charlotte Owens as head of medical affairs and outcomes research. 6 September 2023
Biotechnology
Approval has today been granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron XBB 1.5 subvariant, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness. 5 September 2023
Biotechnology
British drug discovery firm Engitix has appointed Christopher Stevenson as chief scientific officer. 5 September 2023
Generics
Privately-held UK headquartered Advanz Pharma has signed an exclusive licensing and supply agreement with GP Pharm for a peptide specialty injectable generic in a rare disease indication for multiple European countries. 4 September 2023
Biotechnology
Infectious disease specialist ExeVir Bio has appointed Viki Bockstal as chief scientific officer and Caroline Sagaert as head of operations, with Jean-Philippe Bultot taking over as head of finance. 1 September 2023
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Biotechnology
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
Samsung Biologics, the biotech arm of Korea's Samsung Group, has announced a new manufacturing agreement worth $668 million. 20 November 2024
Biotechnology
Mirai Bio has announced the appointment of Jens Vogel as the company’s president and chief operating officer (COO). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
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