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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 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 KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics for the treatment of schizophrenia. 26 January 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 26 January 2024
Pharmaceutical
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
Pharmaceutical
The UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a month’s treatment) of the diabetes and weight management medicine Mounjaro (tirzepatide) - Mounjaro KwikPen. 26 January 2024
Pharmaceutical
The European regulatory filing for Acarizax (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation 25 January 2024
Pharmaceutical
UK-based dermatology company SkinBioTherapeutics is to acquire the issued share capital of Dermatonics, a specialist in innovative topical and dermatological products in the skincare and woundcare space. 25 January 2024
Pharmaceutical
Biopharma company Indian Immunologicals Ltd (IIL) has launched India's first indigenously developed hepatitis A vaccine. 24 January 2024
Pharmaceutical
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
Pharmaceutical
The Serum Institute of India (SII), which claims to be the world’s largest vaccine manufacturer, is joining a growing Coalition for Epidemic Preparedness Innovation (CEPI) network of vaccine producers in the Global South to support more rapid, agile, and equitable responses to future public health disease outbreaks. 24 January 2024
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical revealed it has obtained approval in Japan for an additional indication for Rexulti (brexpiprazole) for the treatment of depression/depressive state. 24 January 2024
Pharmaceutical
A new manufacturing plant will be built in Japan, at a cost of over $40 million, by Chinese contract development and manufacturing organization (CDMO) Jiuzhou Pharmaceutical. 24 January 2024
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has announced positive results from the DELTA FORCE trial. 24 January 2024
Pharmaceutical
AI specialist BenevolentAI today announced the appointment of Dr Joerg Moeller as chief executive and executive board member with immediate effect. 24 January 2024
Pharmaceutical
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
Pharmaceutical
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. 24 January 2024
Pharmaceutical
Accent Therapeutics, a US biopharma seeking to develop a new class of small molecule precision cancer therapies, has announced the completion of a $75 million Series C financing. 23 January 2024
Pharmaceutical
As a market leader in obesity therapy and the largest European company by market cap, Danish diabetes care gain Novo Nordisk has entered into another accord to further solidify its dominance. 23 January 2024
Pharmaceutical
US healthcare giant Johnson & Johnson announced its fourth-quarter and annual financial results for 2023 on Tuesday. 23 January 2024
Pharmaceutical
Shares of US radiopharmaceuticals-focussed Lantheus Holdings (Nasdaq: LNTH) were down 5.4% at $51.88 by late morning today, as it announced the appointment of Brian Markison, current board chairman and industry veteran, to the position of chief executive (CEO), effective as of March 1, 2024. 23 January 2024
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma says it has finalized the acquisition of the strategic asset TMB-001 as well as certain other assets from Timber Pharmaceuticals following the US firm’s Chapter 11 bankruptcy filing. 23 January 2024
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