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
The US Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica. 4 April 2024
LENZ Therapeutics, a biopharma focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, is a step closer to realizing its ambition. 4 April 2024
First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23. 4 April 2024
Russian patients with diabetes have been faced with serious difficulties in obtaining ultra-fast insulin aspart Fiasp from Denmark’s Novo Nordisk, reports The Pharma Letter’s local correspondent 3 April 2024
A major public-private research initiative in the UK, Our Future Health, has added a new partner from industry, Swiss pharma giant Novartis. 3 April 2024
Shares of US neurological drug specialist Acorda Therapeutics fell more than 81% to $2.50 by close on Monday after the company said it had filed for bankruptcy protection. 3 April 2024
A start-up focused on neurology, Neurosterix, has launched with a $63 million series A financing led by Perceptive Xontogeny Venture Fund II. 3 April 2024
The US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) has released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. 3 April 2024
UK-based specialty CNS-focused pharma company CNX Therapeutics today announce that it has successfully completed the acquisition of two CNS products from the French sales subsidiary of Japan’s Eisai. 2 April 2024
A report released by the non-profit group No Patient Left Behind has claimed that it has found critical flaws in a key metric used by US insurance companies and foreign governments to determine whether to cover prescribed treatments at low out-of-pocket costs. 2 April 2024
Danish pharma trade group Lif has expressed concerns over a new bill that will make it mandatory for companies to set up safety stocks of critical medicines. 2 April 2024
With new legislation on data protection in the offing, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on negotiators to take more time to make sure the law is drafted optimally. 2 April 2024
A new collaboration has been agreed between Israel’s Teva Pharmaceutical and Launch Therapeutics, related to the candidate TEV-248, which combines fluticasone and albuterol. 2 April 2024
Swiss contract development and manufacturing organization (CDMO) Lonza today announced that Wolfgang Wienand has been appointed chief executive (CEO). 2 April 2024