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 the first three quarters of 2023, Denmark’s expenditure on the purchase of hospital medicine rose by 2.5% to almost 6.6 billion Danish kroner ($974.5 million). 26 December 2023
US drugmaker Cidara Therapeutics’ shares advanced 12.5% to $0.83 on Friday, after it announced that Rezzayo (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults. 23 December 2023
In support of US President Biden’s Unity Agenda efforts to beat the overdose epidemic, the US Department of Health and Human Services (HHS) and the General Services Administration (GSA) announced new guidance. 23 December 2023
USA-based Fauna Bio today announced a multi-year agreement with US pharma major Eli Lilly to apply Fauna's Convergence artificial intelligence (AI) platform to support pre-clinical drug discovery efforts in obesity. 22 December 2023
Suzhou, China-based cancer company CStone Pharmaceuticals has inked a deal with French drugmaker Servier to sell certain rights to Tibsovo (ivosidenib). 21 December 2023
For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co for approval to market a chronic cough medication. 21 December 2023
India’s JB Chemicals & Pharmaceuticals saw its shares edge up 2% to 1,488.60 rupees, after it revealed it has acquired around 15 ophthalmology drugs from the Swiss pharma giant Novartis for rupees 964 crore or $116 million. 21 December 2023
Tonix Pharmaceuticals Holding Corp has announced highly statistically significant and clinically meaningful topline results in a second positive Phase III trial of TNX-102 SL for the management of fibromyalgia. 21 December 2023
Japanese drugmaker Shionogi has launched of siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial in Japan. 21 December 2023
As The World Health Organization (WHO) draws to a close COVAX, its pioneering global effort to distribute coronavirus vaccines, the agency said a new strain of the virus, JN.1, would be classed as a "variant of interest." 20 December 2023
The rare disease unit of Italian drugmaker Chiesi has secured US approval for Filsuvez (birch triterpenes), a new treatment for people with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). 20 December 2023
The contraceptives market across the seven major markets (7MM: the USA, France, Germany, Italy, Spain, UK and Japan) is forecast to slightly increase at a compound annual growth rate (CAGR) of 0.5% from $7.8 billion in 2022 to $8.2 billion in 2032. 20 December 2023
Foreign contract research companies (CROs) are suspending participating in clinical trials in Russia after the exodus of global drugmakers from the clinical research market in the country earlier this year, reports The Pharma Letter’s local correspondent. 20 December 2023
Midsize Japanese drugmaker Otsuka Pharmaceuticals has entered into a licensing agreement with Ionis Pharmaceuticals related to its candidate donidalorsen. 19 December 2023
Hoping to capitalize on a tsunami of interest in GLP-1 agonists for weight loss, Structure Therapeutics has now published Phase IIa data for its oral candidate, but investors are not happy. 19 December 2023
In a new move within the pharmaceutical industry, French pharma major Sanofi has entered into a $140 million deal with Aqemia, a French pharmaceutical technology company. 19 December 2023
Vicore Pharma, a Swedish pharma company seeking to unlock the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), has announced that Bertil Lindmark will join as chief medical officer. 18 December 2023