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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
The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules. 8 May 2024
Pharmaceutical
Chinese metabolic disease company Sciwind Biosciences has inked a deal with HK inno.N, a South Korean commercial stage drugmaker. 8 May 2024
Pharmaceutical
The top management of life sciences companies is very optimistic about 2024 and 2025, with over 80% of pharmaceutical, medical technology and biotechnology executives expecting profit growth for the current year and over 90% for the coming year. 8 May 2024
Pharmaceutical
Final results from a three-year open-label extension study of Fintepla (fenfluramine) have been released by Belgium’s UCB. 8 May 2024
Pharmaceutical
The US drugmaker Baxter (NYSE: BAX), one of the largest suppliers of dialysis solutions, has suspended its commercial activities in Russia. 8 May 2024
Pharmaceutical
Privately-held Isotope Technologies Munich (ITM) has announced the appointment of Danielle Meyrick as chief medical officer (CMO). 8 May 2024
Pharmaceutical
Half of pharma execs are bracing for significant revenue impact from Medicare price negotiations this year, compared to just 22% in 2023, according to research from revenue and compliance experts at Model N. 7 May 2024
Pharmaceutical
US biopharma Vertex Pharmaceuticals remains an evergreen pick in the stock market, announcing another set of financial results that exceeded expectations. 7 May 2024
Pharmaceutical
A trial flop for Massachusetts, USA-based EyePoint Pharmaceuticals has triggered a sell-off from investors, with the price of a share dropping by around half. 7 May 2024
Pharmaceutical
Swiss drug developer Atopia Therapeutics has appointed Dr Grégoire Chevalier as chief executive (CEO). 7 May 2024
Pharmaceutical
Three of the world’s largest public health organizations are to join forces, backing a new research and development initiative with $300 million in funding. 7 May 2024
Pharmaceutical
The British and Irish business of California’s Gilead Sciences has appointed Peter Wickersham to the role of VP and general manager for the UK and Ireland. 7 May 2024
Pharmaceutical
Catalent and the Novo Nordisk Foundation (as the ultimate parent entity of Novo Holdings and Novo Nordisk) announced that, on May 2, they each received a request for additional information and documentary materials (the second request) from the US Federal Trade Commission (FTC) in connection with the proposed merger. 7 May 2024
Pharmaceutical
Maryland, USA–based glycobiology specialist GlycoMimetics has seen its share price fall around 80% after the failure of a Phase III trial. 7 May 2024
Pharmaceutical
US pharma giant Pfizer on Monday revealed that Dr Andrew Baum will join the company as chief strategy and innovation officer, executive vice president. 7 May 2024
Pharmaceutical
The Bilateral III, a third package of bilateral agreements between the European Union (EU) and Switzerland on participation in the Single Market, ensures unhindered access to the European internal market and puts the economic and political relationship with the EU on a solid foundation, says the Swiss trade group InterPharma. 7 May 2024
Pharmaceutical
Sentynl, the USA-based wholly-owned subsidiary of Indian generics major Zydus Lifesciences, has announced the closing of the sale of Eiger BioPharmaceuticals’ Zokinvy (lonafarnib) program to Sentynl. 4 May 2024
Pharmaceutical
A Q&A with the man who heads the UK business of the privately-held Italian drugmaker. 3 May 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved two new formulations of the medicine cabotegravir to help prevent sexually transmitted HIV-1 infection. 3 May 2024
Psychedelics
Philadelphia, USA-based Reunion Neuroscience, a company developing psychedelics for the treatment of mental health conditions, has announced the closing of a $103 million Series A financing. 3 May 2024
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