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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
The USA’s Federal Trade Commission yesterday issued a comment in response to the National Institute of Standards and Technology’s (NIST) request for information on its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act. 7 February 2024
Pharmaceutical
French pharma major Sanofi has announced that Rippon Ubhi has been appointed as country lead for the UK and Ireland, taking over immediately from Jessamy Baird. 7 February 2024
Pharmaceutical
CNS specialist Lundbeck has reported record annual revenue for 2023 of 19.91 billion Danish kroner ($2.87 billion), a 9% increase on 2022. 7 February 2024
Pharmaceutical
US pharma major Eli Lilly posted its fourth-quarter and full-year financial results on Tuesday. 6 February 2024
Pharmaceutical
US biopharma Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor program, the most comprehensive Phase III pivotal program ever conducted by the company for cystic fibrosis (CF). 6 February 2024
Pharmaceutical
Clinical-stage US biotech Acumen Pharmaceuticals has appointed James Doherty as president and chief development officer, effective February 1, 2024. 6 February 2024
Pharmaceutical
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
Pharmaceutical
Denmark-based Novo Holdings has entered into a merger agreement to acquire US contract development and manufacturing organization (CDMO) Catalent. 5 February 2024
Pharmaceutical
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
Pharmaceutical
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Pharmaceutical
In the USA, the House of Representatives have voted overwhelmingly in favor of legislation which would restore the ability of drugmakers to fully expense R&D costs incurred within the same tax year. 5 February 2024
Pharmaceutical
The risk of developing and surviving cancer are shaped by where you live, according to a new report on the situation in Europe. 5 February 2024
Pharmaceutical
Japan’s largest drugmaker Takeda Pharma has appointed Dr Phuong Khanh (PK) Morrow as head of the Oncology Therapeutic Area Unit, effective as of January 29. 3 February 2024
Pharmaceutical
The year has started with a bang in pharma M&A. 2 February 2024
Pharmaceutical
Bristol Myers Squibb has reported strong fourth quarter revenues of $11.5 billion and earnings per share (EPS) of $1.70, both higher than many analysts had forecast. 2 February 2024
Pharmaceutical
US drugmaker AbbVie has finally faced its D-Day, having had to deal with declining revenues from its inflammatory diseases drug Humira (adalimumab) due to the first US competition to the mega blockbuster. 2 February 2024
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan, from Novartis and danicopan from AstraZeneca’s rare diseases unit Alexion, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 2 February 2024
Pharmaceutical
Spanish plasma-derived products specialist Grifols says it has reinforced its senior management team with two appointments. 2 February 2024
Pharmaceutical
Positive high-level results from the Japan Phase III trial of acoramidis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed consistency to those in the global BridgeBio Pharma ATTRibute-CM Phase III trial, including survival, cardiac-related hospitalizations and other measures of improved functions and quality of life, at 30 months. 2 February 2024
Pharmaceutical
Yesterday, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), said it is sending initial offers to the participating drug companies of the first 10 prescription drugs selected for negotiation in the first cycle of the Medicare Drug Price Negotiation Program. 2 February 2024
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