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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 US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam. 26 February 2024
Pharmaceutical
UK pharma major GSK today announced positive headline results from the pivotal EAGLE-1 Phase III trial for gepotidacin. 26 February 2024
Pharmaceutical
The US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
Pharmaceutical
Biotech company United Therapeutics Corporation has launched a lawsuit against the US Food and Drug Administration (FDA). 23 February 2024
Pharmaceutical
Danish CNS specialist Lundbeck today announced a number of changes in its executive management team, first noting that Jacob Tolstrup, executive vice president, commercial operations, will leave the company no later than March 1, 2024. 23 February 2024
Pharmaceutical
Italian pharma major Recordati saw its shares dip 1.5% to 51.30 euros today, despite releasing a strong set of financial results for full year 2023. 22 February 2024
Pharmaceutical
Japanese drugmaker Shionogi today revealed that it has received approval from the Taiwan Food and Drug Administration (TFDA) for Fetroja (cefiderocol) in the treatment of complicated urinary tract infections. 22 February 2024
Pharmaceutical
German family-owned drugmaker InfectoPharm Arzneimittel und Consilium GmbH has set up a further European subsidiary – this time in France. 22 February 2024
Pharmaceutical
ViiV Healthcare today announced results from an interim analysis of the LATITUDE Phase III trial, indicating its long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy. 21 February 2024
Pharmaceutical
India's pharma landscape has undergone a significant shift towards collaboration and partnership between global big pharma and domestic firms in recent years to drive innovation and expand market reach, according to GlobalData. 21 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) submitted by pharma major Bristol Myers Squibb for Krazati (adagrasib) in combination with cetuximab. 21 February 2024
Pharmaceutical
GlobalData has taken a look at shifts in market capitalization among the world’s top 20 biopharma companies during 2023. 20 February 2024
Pharmaceutical
US pharma major AbbVie today announced a succession plan, to replace its current chief executive (CEO). 20 February 2024
Pharmaceutical
Indian drugmaker Cipla Limited has entered into a collaborative research agreement with CSIR-Central Drug Research to jointly develop a novel ophthalmic formulation for fungal keratitis. 20 February 2024
Pharmaceutical
Australia’s Starpharma has announced that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel BV (SPL7013/astodrimer sodium). 20 February 2024
Pharmaceutical
German pharma and crop sciences major Bayer plans to amend its dividend policy to pay out the legally required minimum for three years. 20 February 2024
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Velsipity (etrasimod) to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC). 19 February 2024
Pharmaceutical
Spanish dermatology company Almirall has announced its annual 2023 financial results. 19 February 2024
Pharmaceutical
Japan’s Ono Pharmaceutical today announced that it has entered into a research collaboration agreement with USA-based artificial intelligence (AI) company to identify novel therapeutic targets by leveraging cutting-edge InveniAI’s AI and machine learning (ML). 19 February 2024
Pharmaceutical
Japanese drugmaker Kyowa Kirin announced that Phozevel Tablets (tenapanor hydrochloride, development code: KHK7791) will be launched in Japan on February 20 for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. 19 February 2024
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