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
US AI-enabled drug discoverer VantAI has entered into a strategic collaboration with pharma major Bristol Myers Squibb to discover new molecular glues for therapeutic targets of interest. 14 February 2024
KalVista Pharmaceuticals shares, which closed Monday at $16.04, were recently up 37% to $22 in pre-market activity, but fell back almost 13% to $14.01 by late morning today, after it released new research data. 13 February 2024
Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Shares of Japanese drugmaker Otsuka Pharmaceutical fell more than 5% to 5,359 yen today, as it released top line results of the Phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease. 13 February 2024
The Yellow Card Biobank, a pilot launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, is to start investigating a group of medicines used to prevent strokes known as direct oral anticoagulants (DOACs). 13 February 2024
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
Foghorn Therapeutics has announced that its partner, Eli Lilly has selected FHD-909, a first-in-class oral BRM selective inhibitor, for clinical development. 12 February 2024
The USA-based AMR Industry Alliance conducted a review of publicly available data on the state of antimicrobial resistance (AMR) research and development talent. 12 February 2024
Danish drugmaker Lundbeck has its eye on steady growth over the medium term, a strategy which new chief executive Charl van Zyl believes could be key to the firm’s future success. 12 February 2024
UK-based Poolbeg Pharma has announced that research conducted on its behalf confirms a market opportunity of at least $10 billon for POLB 001 in cancer immunotherapy-induced cytokine release syndrome (CRS) as an orally-delivered preventative therapy. 12 February 2024
Spanish plasma-derived products specialist Grifols has announced that Raimon Grifols and Víctor Grifols Deu have chosen to step down from their executive functions – chief corporate officer and chief operating officer, respectively. 12 February 2024
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Japan’s largest drugmaker Takeda Pharma has announced positive top-line results from a randomized, double-blind, placebo-controlled, multiple dose Phase IIb trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. 9 February 2024
Vicor Pharma has entered into an exclusive licensing agreement with Japan’s Nippon Shinyaku, for the commercialization and development of its C21 idiopathic pulmonary fibrosis (IPF) drug candidate in Japan. 9 February 2024
Despite posting positive clinical trial results for its resmetirom, being trialled in the treatment of non-alcoholic steatohepatitis (NASH,) US drug developer Madrigal Pharmaceuticals saw its shares close down more than 9% at $173.71 yesterday. 9 February 2024
In an Expert View piece, Mark Seymour, Director and Head of Media, Healthcare, at FleishmanHillard London, argues that in the ever-evolving world of healthcare, the rules of communications have not changed, they have just become more intricate, demanding a renewed focus on the essentials. 8 February 2024