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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
Taiho Ventures unit has been selected as a certified venture capital of the Strengthening Program for Pharmaceutical Startup Ecosystem implemented by the Japan Agency for Medical Research and Development (AMED) and has entered into an agreement with AMED. 2 April 2024
Pharmaceutical
Marking a second regulatory authorization, Voydeya (danicopan) has now been approved in the USA as add-on therapy for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). 2 April 2024
Pharmaceutical
Joint Clinical Assessments (JCA) can support getting new innovative cancer medicines to patients faster, if the right balance in evidence generation and assessment to facilitate national decisions on access for these innovations can be found. 2 April 2024
Pharmaceutical
Viatris today announced the US commercial launch of Ryzumvi (phentolamine ophthalmic solution). 1 April 2024
Pharmaceutical
US pharma major Bristol Myers Squibb yesterday announced a disappointing update following the initial analysis of results from the first of two induction studies in the Phase III YELLOWSTONE. 29 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) as a treatment of classic galactosemia by three months. 29 March 2024
Pharmaceutical
Just as MDMA looked to be leading the charge of psychedelics and related compounds towards market for mental health conditions, a dose of jeopardy has been thrown into the mix. 28 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 28 March 2024
Pharmaceutical
US biopharma Altimmune has claimed that it could have something special on its hands in the highly lucrative obesity field. 28 March 2024
Pharmaceutical
Swedish biotech Oncopeptides yesterday announced a collaboration with Vector Pharma FZCO to commercialize its flagship drug Pepaxti (melphalan flufenamide in the Middle East and North Africa (MENA) region. 28 March 2024
Pharmaceutical
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
Pharmaceutical
A South Korean company, AriBio, has announced the signing of exclusive marketing rights for its investigational Alzheimer’s disease drug, AR1001. 27 March 2024
Pharmaceutical
In what is seen as an important win for Merck & Co, the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair). 27 March 2024
Pharmaceutical
A $20 million series A fundraise will propel Edgewood Oncology out of stealth mode and through early stage research for BTX-A51. 27 March 2024
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and Japanese drugmaker Daiichi Sankyo have been called out for breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. 27 March 2024
Pharmaceutical
Building on positive Phase I/IIa data for its Dravet syndrome candidate, Stoke Therapeutics now hopes to jump towards pivotal research. 27 March 2024
Pharmaceutical
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical have secured European approval for a new formulation of Abilify Maintena (aripiprazole). 27 March 2024
Pharmaceutical
The European Medicines Agency (EMA) has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. 27 March 2024
Pharmaceutical
Veeda Clinical Research Limited, a full-service contract research organization (CRO) with a proven record of drug development success, announced that it has acquired Heads, a privately held European CRO, which specializes in conducting clinical trials in oncology. 27 March 2024
Pharmaceutical
Not-for-profit research partnership TB Alliance has won a A$17 million grant from the Australian government to continue its work combating tuberculosis. 26 March 2024
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