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Pharmaceutical
The Center for Biologics Evaluation and Research (CBER), part of the US Food and Drug Administration, saw its top vaccine official pushed out of the post on Friday, according to people familiar with the matter, according to a Wall Street report. 29 March 2025
Pharmaceutical
Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025
Pharmaceutical
Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025
Pharmaceutical
Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025
Pharmaceutical
Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025
Pharmaceutical
US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025
Pharmaceutical
UK pharma major AstraZeneca has scrapped its plans to invest £450 million in expanding ($559 million) to expand its vaccine plant in Speke, Liverpool, blaming a reduction in government support. 1 February 2025
Pharmaceutical
Evaxion Biotech has priced a public offering, seeking to raise $10.8 million before expenses, with closing anticipated tomorrow. 30 January 2025
Pharmaceutical
hVIVO, a fast-growing early-stage German contract research organization (CRO) has acquired two clinical research units from Clinical Research Services (CRS), in Mannheim and Kiel, Germany, for a total of 10 million euros ($10.5 million). 29 January 2025
Pharmaceutical
Privately-held US biopharma Bluejay Therapeutics has announced that its lead product candidate brelovitug—also known as BJT-778—has received US Food and Drug Administration Breakthrough Therapy designation for the treatment of chronic hepatitis D. 22 January 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jeraygo (aprocitentan) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension). 17 January 2025
Pharmaceutical
The US Food and Drugs Administration (FDA) has confirmed that Center for Drug Evaluation and Research (CDER) director, Patrizia Cavazzoni, has announced her resignation ahead of Donald Trump’s inauguration on January 20, according to media reports. 11 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). 10 January 2025
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
Japanese drugmaker Otsuka Pharmaceutical and its US subsidiary have decided to terminate the development of the novel compound AVP-786, which was being studied as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. 23 May 2024
Pharmaceutical
Biomarker-driven clinical research and development company Precision for Medicine has announced that Harpreet Singh has joined the Maryland firm as chief medical officer. 22 May 2024
Pharmaceutical
Privately-held Swiss company Swixx Biopharma today announced a strategic acquisition of Biopas, one of Latin America’s leading marketing and distribution companies for international biopharmaceutical firms. 22 May 2024
Pharmaceutical
Rhythm Pharmaceuticals, a US biopharma specializing in rare neuroendocrine diseases, has announced that its drug Imcivree (setmelanotide) is expected to be funded and available for use in England and Wales within three months through the National Health Service (NHS) in specialist centers. 22 May 2024
Pharmaceutical
The Journal of Clinical Psychopharmacology has published a post hoc analysis of data from the Phase III KINECT-4 study of Ingrezza (valbenazine). 22 May 2024
Pharmaceutical
Taking another step into the sector, US pharma major Eli Lilly has signed an agreement with Boston, USA-based biotech firm Aktis Oncology, to generate anticancer radiopharmaceuticals using the latter’s novel miniprotein technology platform. 21 May 2024
Pharmaceutical
Foghorn Therapeutics has announced the pricing of a direct share offering, with the goal of raising $110 million. 21 May 2024
Pharmaceutical
Israeli dermatology company Sol-Gel Technologies has signed an agreement with Beimei Pharma for the commercialization of Twyneo (tretinoin/benzoyl peroxide) in China, Hong Kong, Macau, Taiwan and Israel. 21 May 2024
Pharmaceutical
While AstraZeneca’s chief executive Pascal Soriot has been proven right about many of his prior boasts on the company’s future success during his 12-year reign, his latest claim could be questioned even by his strongest supporters. 21 May 2024
Pharmaceutical
The use of AI across all industries and sectors has been heralded as driving efficiency and accelerating innovation, with some experts even citing the technology as the biggest disruptor of our lifetime. 21 May 2024
Pharmaceutical
Following a review of its strategic options, Swedish immunology company InDex Pharmaceuticals has opted for a reverse merger with Stockholm-based Flerie Invest. 21 May 2024
Pharmaceutical
Rapport Therapeutics, a company with a footprint in both Boston and San Diego, USA, has outlined plans for an initial public offering. 20 May 2024
Pharmaceutical
Gilead Sciences has announced positive interim results from the ongoing ASSURE study of seladelpar. 20 May 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced that the primary endpoint was achieved in the Phase III trial in Japan of bempedoic acid as a potential treatment for patients with hypercholesterolemia. 20 May 2024
Pharmaceutical
Finnish pharma trade group Pharma Industry Finland (PIF) has published its annual survey into investment levels in the nation. 20 May 2024
Pharmaceutical
Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to a report by the Irish Pharmaceutical Healthcare Association (IPHA), which represents the research-based biopharmaceutical industry. 20 May 2024
Pharmaceutical
Swiss cancer giant Novartis and German drugmaker Bayer are among the latest companies to lift the lid on upcoming data presentations at ASCO 2024. 17 May 2024
Expert View
In an Expert View column, Bruce Leuchter, chief executive of Neurvati Neurosciences, a Blackstone Life Sciences portfolio company, outlines the importance of increased investment in research and development and innovative business models, to bring more therapies for neurological disorders to patients. 17 May 2024
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has received supplemental approvals for the BRAF inhibitor Braftovi (encorafenib), and the MEK inhibitor Mektovi (binimetinib), when used in combination, in Japan for two new indications. 17 May 2024
Pharmaceutical
At its meeting this week the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reviewed medicines regarding their safety. 17 May 2024
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