In Brief
Refine Search
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
Precision oncology platform company Tavros Therapeutics has achieved two milestone payments in its collaboration with the Bayer subsidiary Vividion Therapeutics. 14 May 2024
Pharmaceutical
Chinese biopharma company Everest Medicines announced that Nefecon, a delayed release capsule of budesonide, has been successfully launched in China with the first prescription issued. 14 May 2024
Pharmaceutical
A new study by diabetes awareness website Diabetes Strong reveals that “How to get Ozempic” is the most googled question about the medication. 14 May 2024
Pharmaceutical
French pharma major Sanofi has announced an investment of more than 1 billion euros ($1.08 billion) to create new bioproduction capacity at its sites in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône). 14 May 2024
Pharmaceutical
Diversified German drugmaker Bayer has reported group sales of 13.8 billion euros ($14.9 billion) for the first quarter of 2024, a fall of around 0.6%, meeting expectations. 14 May 2024
Pharmaceutical
US drugmaker AbbVie has become one of the first big pharma companies to place a major bet on neuroplastogens for the treatment of mental health problems. 13 May 2024
Pharmaceutical
The Phase III study (SCORPIO-HR) with ensitrelvir did not meet its primary endpoint of a statistically-significant reduction in time to sustained resolution of 15 common COVID-19 related symptoms, said Japanese drugmaker Shionogi. 13 May 2024
Pharmaceutical
Spanish dermatology company Almirall impressed investors with its financial results for the first quarter of 2024, which were presented on Monday. 13 May 2024
Pharmaceutical
Danish CNS specialist Lundbeck today announced that Maria Alfaiate has been appointed to the newly-created role of executive vice president, commercial and corporate strategy, and will take up the position on August 1. 13 May 2024
Pharmaceutical
Huntington's disease (HD) is a progressive neurodegenerative disorder characterized by involuntary movements, cognitive decline, and emotional disturbances.1 Recent global prevalence data cites 4.88 per 100,000 persons and an incidence of 0.48 cases per 100,000 person-years.2 13 May 2024
Pharmaceutical
An amendment to the Medicines Act, which entered into force on January 1, 2024, already now gives the Danish Medicines Agency the opportunity to, on its own initiative, allow the sale or supply of medicines without a Danish marketing authorization from abroad in the event of a supply failure. 13 May 2024
Pharmaceutical
Italian drugmaker Recordati has recorded net revenues of 608 million euros ($650 million) in the first quarter of 2024, up 10.2%. 10 May 2024
Pharmaceutical
French pharma major Sanofi says that, as part of its commitment to developing a diverse portfolio of best-in-class vaccines, it has entered into a co-exclusive licensing agreement with US biotech Novavax. 10 May 2024
Pharmaceutical
China’s Innovent Biologics has presented impressive results on mazdutide, its dual GLP-1/glucagon receptor agonist partnered with US pharma major Eli Lilly. 10 May 2024
Pharmaceutical
As artificial intelligence (AI) and machine learning (ML) continue to revolutionize various industries, the pharmaceutical sector is no exception. Indeed, there has been a substantial surge in drug and biologic submissions incorporating AI/ML components, exceeding 100 submissions in 2021 alone.1 10 May 2024
Pharmaceutical
UK respiratory disease specialist Verona Pharma and its wholly-owned subsidiary, Verona Pharma Inc (VPI) have entered into strategic financing agreements securing access to up to $650 million. 10 May 2024
Pharmaceutical
In a bid to retain its leadership position in the ever-expanding obesity sector, Novo Nordisk has inked another research collaboration, adding to a string of M&A and licensing deals over the past couple of years. 9 May 2024
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and France-based Medincell have announced results from the efficacy portion of the Phase III SOLARIS trial of olanzapine once-monthly long-acting injectable in schizophrenia compared to placebo. 9 May 2024
Pharmaceutical
Japan's largest drugmaker Takeda Pharmaceutical today announced a restructuring, as annual profit for the fiscal year to March 31, 2024 slid by more than half following the loss of patent protection of major sellers. 9 May 2024
Pharmaceutical
On Wednesday, the American Heart Association (AHA)/American College of Cardiology (ACC) Joint Committee on Clinical Practice Guidelines issued a new clinical guideline for the evaluation and management of people with hypertrophic cardiomyopathy (HCM). 9 May 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze