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
In a third-quarter financial results season when most pharma companies have pleased shareholders with better-than-expected figures, the reaction to Sanofi’s presentation on Friday has provided a stark contrast. 27 October 2023
There was good news for the makers of some diabetes and obesity drugs today, when the European regulator found no link to thyroid cancer scares. 27 October 2023
US pharma major AbbVie’s shares were down 3.3% at $140.24 early today, after it released financial results for the third quarter of 2023. 27 October 2023
Tokyo-headquartered pharma major Takeda has announced results for the first half of its fiscal year, which in Japan runs from April 1 to September 1. 27 October 2023
Japanese drugmaker Otsuka today announced positive results of two, six-week, Phase III clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD). 27 October 2023
The US Food and Drug Administration (FDA) yesterday approved the new drug application (NDA) for Agamree (vamorolone) as a treatment of patients aged two years or more with Duchenne muscular dystrophy (DMD), that was submitted by Swiss drugmaker Santhera Pharmaceuticals. 27 October 2023
US pharma giant Merck & Co has opted to pull the plug on two mid-stage trials of Alzheimer’s disease candidate MK-1942, due to safety worries. 26 October 2023
US Pharma major Bristol Myers Squibb today reported results for the third quarter of 2023, which the company says reflect significant pipeline progress and advances in the portfolio renewal strategy. 26 October 2023
Danish diabetes care giant Novo Nordisk recently revealed that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. 26 October 2023
China’s National Medical Products Administration (NMPA) has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. 26 October 2023
USA-based BioXcel Therapeutics on Wednesday revealed that an independent third-party review of the data from a site in its TRANQUILITY II Phase III trial showed "positive findings." 26 October 2023
Barcelona, Spain-based plasma-derived medicine specialist Grifols saw its shares close down more than 5% at 9.88 euros, despite announcing positive results for a potential Alzheimer’s vaccine candidate. 25 October 2023
UK pharma major GSK (LSE: GSK) today announced positive preliminary results from its Phase III trial the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59. 25 October 2023
French biotech Abivax has completed an initial public offering (IPO), listing on the Nasdaq global market with 20,325,500 new ordinary shares being issued. 25 October 2023
The US Food and Drug Administration yesterday approved Tibsovo (ivosidenib), from French independent pharm major Servier, for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. 25 October 2023
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma announced. 24 October 2023
Seven vaccine research proposals have been chosen for funding, the latest development in a partnership between the Bill and Melinda Gates Foundation and the National Natural Science Foundation of China (NSFC). 24 October 2023