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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
Italy-based biopharma Newron Pharmaceuticals was trading 14% higher at lunchtime on Tuesday. 30 April 2024
Pharmaceutical
USA-based neurodegenerative disorders specialist Annovis Bio saw its shares plunge 60% to $7.28 by close of trading, despite what it said were positive results for its Alzheimer’s disease (AD) candidate. 30 April 2024
Pharmaceutical
More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 April 2024
Pharmaceutical
The world’s top 20 pharma companies spent $145 billion between them on R&D investments in 2022-23 - compared to the prior year’s $139 million - according to research from the professional services firm Deloitte. 29 April 2024
Pharmaceutical
Osaka, Japan-based drugmaker Ono Pharmaceutical has entered into a drug discovery collaboration agreement with fellow Japanese firm PRISM BioLab. 29 April 2024
Pharmaceutical
Interpharma, the association of research-based pharmaceutical companies in Switzerland, has called on lawmakers to reconsider a cost containment package which it says “is putting patient access at risk.” 29 April 2024
Pharmaceutical
Family-controlled Spanish pharma company Esteve has signed a binding offer with USA-based Perrigo Company to acquire the latter’s HRA Pharma Rare Diseases, a specialist in rare and ultra-rare diseases. 29 April 2024
Pharmaceutical
The fact that the government has exempted the parallel importers from the obligation to contribute to the critical medicine stocks creates an extremely competitive situation, says Ida Sofie Jensen, chief executive of Lif, the Danish Association of the Pharmaceutical Industry. 29 April 2024
Pharmaceutical
US pharma major AbbVie announced financial results for the first quarter of 2024, showing that worldwide net revenues were $12.310 billion, an increase of 0.7% on a reported basis, or 1.6% on an operational basis. 26 April 2024
Pharmaceutical
Privately-held Isotope Technologies Munich (ITM) is not just the radiopharmaceutical company that can do it all - from manufacturing and supplying medical radioisotopes to developing a broad precision oncology pipeline, including two Phase III studies. 26 April 2024
Pharmaceutical
In a recent comment letter to US President Biden’s trade ambassador, Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the US Trade Representative (USTR) to strengthen medical supply chains by negotiating meaningful trade agreements. 26 April 2024
Pharmaceutical
US pharma giant Merck & Co raised and narrowed its forecasts for profit and sales for 2024 in presenting its first-quarter financial results. 25 April 2024
Pharmaceutical
In its first quarter 2024 results statement, Bristol Myers Squibb beat expectations on revenues, which increased 5% to $11.9 billion, although it posted a loss per share of $5.89, due to charges from recently-closed deals. 25 April 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published its Final Draft Guidance (FDG) on a combination therapy from Swiss pharma giant Novartis. 25 April 2024
Pharmaceutical
A key Senate committee has launched an investigation into how Novo Nordisk prices its popular weight-loss drug semaglutide in the USA. 25 April 2024
Pharmaceutical
Sanofi shares were up by nearly 4% during Thursday’s early afternoon trading in Paris following its results presentation.. 25 April 2024
Pharmaceutical
Belgium’s largest drugmaker UCB today announced an update on its progress at its annual shareholder meeting (AGM), with the news edging its shares up 1.7% to 122.90 by midday. 25 April 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
Pharmaceutical
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
Pharmaceutical
Swiss pharma giant Roche first-quarter 2024 sales figures this morning that were disappointing in some respects and saw the firm’s shares fall 3.5% to 221.70 francs. 24 April 2024
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