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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
German pain specialist Grünenthal has released its 2023 full-year results, announcing a double-digit revenue growth. 26 March 2024
Pharmaceutical
Cohance Lifesciences and Suven Pharma are to merge, creating one of India's largest integrated contract development and manufacturing organization (CDMO) players. 26 March 2024
Pharmaceutical
New York-based Nuvation Bio, a biopharma tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, is to buy AnHeart Therapeutics. 26 March 2024
Pharmaceutical
US privately-held biopharma Pharmazz and Dr Reddy's Laboratories have enter into licensing agreement to market first-in-class centhaquine (trade name Lyfaquin) for hypovolemic shock in India. 26 March 2024
Pharmaceutical
New York-based Axsome Therapeutics has announced positive results from the Phase III SYMPHONY trial of reboxetine. 26 March 2024
Pharmaceutical
Drug sales in the Russian market are steadily growing, while last year the overall retail sales increased by 8% year-on-year basis to 1.5 trillion roubles $16.2 billion), according to latest data, provided by the Russian pharmaceutical analytics agency RNC Pharma, reports The Pharma Letter’s local correspondent. 26 March 2024
Pharmaceutical
Pharmaceutical companies from so-called “unfriendly” countries for Russia will be required to coordinate transactions for the sale of brands and means of individualization in the country’s pharmaceutical market to local legal entities with the specially established state regulator in order to tighten a control for them and prevent the illegal withdrawal funds from the local market. 25 March 2024
Pharmaceutical
In the fragmented and complex US healthcare system, the market value of pharmacy benefit managers (PBM) has reached new heights. 25 March 2024
Pharmaceutical
Swedish biotech Sobi has announced positive results from the AVA-PED-301 study, evaluating the efficacy and safety of Doptelet (avatrombopag). 25 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil), a single-tablet combination of an endothelin receptor antagonist (ERA), and a phosphodiesterase 5 (PDE5) inhibitor. 25 March 2024
Pharmaceutical
An Expert View from Rajan Jethwa, chief executive of Ellipses Pharma. 24 March 2024
Pharmaceutical
At its March management board meeting, the European Medicines Agency adopted the EMA’s annual report for 2023, noting that, in 2023, Agency recommended 77 medicines for marketing authorization for human use, 39 of which had a new active substance, and adopted the EMA’s annual report for 2023. 23 March 2024
Pharmaceutical
Germany's Bayer has announced a restructure of the executive leadership team of its Pharmaceuticals Division. 22 March 2024
Pharmaceutical
Oslo, Norway-based Photocure said today that it has received notice from medicines regulator Health Canada approving the product monograph for its Cysview (hexaminolevulinate hydrochloride). 22 March 2024
Pharmaceutical
This year could be a crucial one for Maat Pharma, a French microbiome company with a focus on cancer. 22 March 2024
Pharmaceutical
US clinical-stage company OKYO Pharma’s shares rose 5.7% to $1.86 pre-market today, as it announced additional key findings from analyses of the clinical data set from the 240 patient Phase II, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). 22 March 2024
Pharmaceutical
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Pharmaceutical
Swiss rare disease specialist Relief Therapeutics today announced it has granted an exclusive license to Eton Pharmaceuticals or the commercialization of GOLIKE family of products in the USA. 22 March 2024
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Pharmaceutical
Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older. 22 March 2024
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