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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
An Expert View from Adrienne Rivlin, a partner in LEK’s Healthcare practice. 19 April 2024
Pharmaceutical
New data from Japanese drugmaker Shionogi’s largest European real-world evidence study of cefiderocol (PERSEUS), demonstrates strong efficacy in critically ill patients with difficult to treat carbapenem-resistant (CN) Gram-negative (GN) bacterial infections. 19 April 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the first and only ALK inhibitor for people with ALK-positive early-stage NSCLC (eNSCLC). 19 April 2024
Pharmaceutical
Taiwanese infectious disease specialist TaiGen Biotechnology has announced positive results from a Phase III trial of TG-1000. 19 April 2024
Pharmaceutical
US pharm major Eli Lilly and German partner Boehringer Ingelheim recently presented results of the Phase III EMPACT-MI trial, which examined patients treated with sodium-glucose co-transporter-2 inhibitor (SGLT-2I) Jardiance (empagliflozin) following a heart attack, at the American College of Cardiology’s (ACC). 19 April 2024
Pharmaceutical
New York USA-based Metsera, a company accelerating the next generation of medicines for obesity and metabolic diseases, announced its launch today. 18 April 2024
Pharmaceutical
US biotech Vertex Pharmaceuticals’ shares gained ground in early trading today after the company signaled progress in the development of its experimental non-opioid pain treatment. 18 April 2024
Pharmaceutical
Like its rivals in the GLP-1 space, Eli Lilly continues to explore the potential of Zepbound (tirzepatide) in addressing the broad range of comorbidities linked to obesity. 18 April 2024
Pharmaceutical
Global supply problems have caused a “shock rise” in shortages of life-saving drugs like antibiotics and epilepsy medication, new research reveals today. 18 April 2024
Pharmaceutical
At the American College of Cardiology’s 73rd Annual Scientific Session, a study from the Gardy Health system in Atlanta, Georgia, USA, was presented investigating the rates of heart failure hospitalizations (HFH) in heart failure with preserved ejection fraction (HFpEF) patients and diabetes patients on semaglutide. 18 April 2024
Pharmaceutical
UK pharma major GSK has announced positive results from the pivotal EAGLE-1 Phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. 18 April 2024
Pharmaceutical
Western drugmakers are reducing their presence in Russia, which is reflected by the drop of demand and sales of their drugs in the local market, The Pharma Letter’s local correspondent reports. 18 April 2024
Pharmaceutical
US brain health company Sage Therapeutics was trading more than 19% lower at lunchtime Wednesday. 17 April 2024
Pharmaceutical
UK-based specialty pharma group Essential Pharma has bought the Reminyl (galantamine hydrobromide) product line from Johnson & Johnson. 17 April 2024
Pharmaceutical
California, USA-based Terns Pharmaceuticals has appointed Melita Sun Jung as chief business officer. 17 April 2024
Pharmaceutical
Shares in US CNS specialist Intra-Cellular Therapies closed 23% higher on Tuesday. 17 April 2024
Pharmaceutical
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 17 April 2024
Pharmaceutical
Medicare beneficiaries in the USA are facing greater access restrictions on their lifesaving medicines, according to a study by the Schaeffer Center at the University of Southern California. 17 April 2024
Pharmaceutical
France-based Medincell, a biopharma developing long-acting injectable drugs in many therapeutic areas, has announced a collaboration with US drugmaker AbbVie. 16 April 2024
Pharmaceutical
US healthcare giant Johnson & Johnson has announced its financial results for the first quarter of 2024. 16 April 2024
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