UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy. 7 January 2025
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
Spanish plasma-derived medicines company Grifols announced with the Andorran government the cancellation of the immunology research center planned for the parish of Ordino. 29 July 2024
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that Lydia Abad-Franch has been appointed as senior vice president, head of research, development and medical affairs (RDMA), and chief medical office, a role which she has held on an interim basis since June. 5 October 2023
Shares of Melbourne, Australia-based Dimerix shot up 154% to A$0.16 on the news of a licensing deal with privately-held UK-based drugmaker Advanz Pharma. 5 October 2023
On Wednesday, the US Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. 5 October 2023
The government of Colombia plans to overcome patent barriers to HIV treatment and import low-cost generic versions of the HIV medicine dolutegravir without permission from the patent owner, ViiV Healthcare. 5 October 2023
French pharma major Sanofi (Euronext; SAN) has entered into a collaboration with the US subsidiary of global generics leader Israel-based Teva Pharmaceutical Industries (NYSE and TASE: TEVA). 4 October 2023
Positive results from the T2NOW Phase III trial have demonstrated significant reduction in A1C, a marker of average blood sugar, for patients treated with Forxiga/Farxiga (dapagliflozin) compared to those receiving placebo. 4 October 2023
California-based Vistagen Therapeutics, a company aiming to transform the treatment landscape for anxiety, depression, and other central nervous system (CNS) disorders, has raised $100 million through an underwritten offering of its common stock. 4 October 2023
US pharma major Eli Lilly today revealed that Mike Mason, executive vice president and president of Lilly Diabetes and Obesity, will retire at the end of 2023 after 34 years with the company. 4 October 2023
Danish diabetes care giant Novo Nordisk’s obesity medication Wegovy (semaglutide) will soon be accessible through the National Health Service (NHS) in England, albeit with limited supply. 4 October 2023
The US Food and Drug Administration has updated the emergency use authorization for the COVID-19 vaccine developed by US biotech Novavax. 4 October 2023
Shares US radiopharmaceuticals firm POINT Biopharma Global shot up 84% to $12.31 in pre-market activity, on the news of a takeover bid from Eli Lilly. 3 October 2023
Despite positive top-line data, Syndax Pharmaceuticals stock has fallen more than a tenth, following an interim analysis from the AUGMENT-101 trial. 3 October 2023
French pharma major Sanofi has signed a research collaboration with US healthcare giant Johnson & Johnson’s subsidiary Janssen Pharmaceuticals. 3 October 2023
In the USA, British drugmaker AstraZeneca has brought to an end certain product liability lawsuits for the gastrointestinal meds Nexium (esomeprazole) and Prilosec (omeprazole). 3 October 2023
The World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) have recommended for approval R21/Matrix-M malaria vaccine. 3 October 2023
Madrigal Pharmaceuticals, a US biopharma pursuing new therapeutics for non-alcoholic steatohepatitis (NASH), has announced the pricing of its underwritten public offering. 2 October 2023
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence on Eliquis (apixaban) and Xarelto (rivaroxaban) for the treatment of non-valvular atrial fibrillation (NVAF). 2 October 2023
Swiss pharma giant Novartis has announced positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study at nine months. 2 October 2023
ModeX Therapeutics, an OPKO Health company, has received a sizeable grant of up to $168 million from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services. 2 October 2023