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Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
US pharma giant Merck & Co has announced results from STRIDE-3, a Phase III trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. 28 November 2023
Pharmaceutical
India's Draft Patents (Amendment) Rules, 2023, that propose several changes to India's patent regime, have raised significant concerns among public health experts, domestic drug industry chiefs, and civil society organizations. 28 November 2023
Pharmaceutical
US biopharma SpringWorks Therapeutics has won a landmark approval from the US Food and Drug Administration (FDA). 28 November 2023
Pharmaceutical
US clinical-stage drug developer Ensysce Biosciences and Sweden’s OncoZenge have signed a letter of intent (LoI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge in the USA. 28 November 2023
Pharmaceutical
Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics for its dry eye candidate reproxalap. 28 November 2023
Pharmaceutical
Russia will significantly reduce public procurements of anti-cancer drugs which are not included in the list of vital drugs due to the lack of funds, reports The Pharma Letter’s local correspondent. 28 November 2023
Pharmaceutical
In the USA, the Biden Administration is currently conducting a government-wide review of the use of “march-in” authority under the Bayh-Dole Act. 28 November 2023
Pharmaceutical
US ophthalmic drug developer Ocuphire Pharma has announced the appointment of Joseph (Joe) Schachle into the newly created role of chief operating officer (COO), effective today. 27 November 2023
Pharmaceutical
China’s Zhifei Biological Products, a developer of vaccines and biological products, plans to acquire Chenan Biopharmaceutical. 27 November 2023
Pharmaceutical
Following a shake-up on the R&D side, British pharma company GSK has opted to stop development of GSK4381406, a GPR35 agonist. 27 November 2023
Pharmaceutical
Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023
Pharmaceutical
An expert has called for governments and industry to make investing in novel antimicrobials a priority. 27 November 2023
Pharmaceutical
Australian dermatology specialist Botanix Pharmaceuticals saw its shares dip 3.2% to A$0.15 this morning, despite announcing receipt of firm commitments for $13.5 million (US) via an institutional placement, with proceeds to support preparation for commercial launch activities for its lead product Sofdra (sofpironium bromide) gel. 27 November 2023
Pharmaceutical
The latest EU Pharma Figures clearly show Belgium has a leading position within the European Union in terms of biopharmaceutical research and development, production and export, says the sector’s trade group pharma.b in a website posting. 27 November 2023
Pharmaceutical
Brazil’s scientific institution for R&D, Fiocruz, through the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) have signed a term of commitment with the National Administration of Laboratories and Institutes of Health Dr Carlos Malbrán (Anlis), aimed at enabling the Argentine institution to produce and supply the yellow fever vaccine in its country. 27 November 2023
Pharmaceutical
A new artificial intelligence (AI)-based model developed by scientists at ETH Zurich could help determine optimal synthesis methods for new active pharmaceutical ingredients (API). 27 November 2023
Pharmaceutical
The European Medicines Agency (EMA) has validated Vertex Pharmaceuticals Type II variation application to the Marketing Authorization for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. 24 November 2023
Pharmaceutical
Californian CNS specialist Alto Neuroscience has completed a $45 million series C financing round led by InVivium Capital. 24 November 2023
Pharmaceutical
AstraZeneca recently announced its strategy for the cardiometabolic market, in particular treating obesity and its comorbidities. 24 November 2023
Pharmaceutical
Chinese biopharma Everest Medicines has won approval from China's National Medical Products Administration (NMPA) for Nefecon (budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. 24 November 2023
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