Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
Spanish plasma-derived medicines company Grifols announced with the Andorran government the cancellation of the immunology research center planned for the parish of Ordino. 29 July 2024
The US Food and Drug Administration (FDA) approved Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp] to include initiation of treatment, up-dosing and maintenance in individuals ages one through three years. 27 July 2024
Vividion Therapeutics, a wholly-owned subsidiary of Germany’s Bayer, today announced it will expand its global innovation capabilities with a new research and development (R&D) center and corporate headquarters in San Diego, California. 23 July 2024
US pharm major Eli Lilly on Friday revealed via a social media posting that it has been granted approval from the Chinese National Medical Products Administration (NMPA) to sell tirzepatide for weight loss in the country. 20 July 2024
The US Food and Drug Administration (FDA) issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). 19 July 2024
Zevra Therapeutics revealed that the US Food and Drug Administration (FDA) has indicated it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2, 2024, to review the New Drug Application (NDA) for arimoclomol. 15 July 2024
Aardvark Therapeutics might not have scored the biggest venture haul in May, but its $85 million Series C round will further strengthen rumors that the California-based company is gearing up for an IPO this summer, which could come as soon as late July. 13 June 2024
The US Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary has released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2023-2032. 13 June 2024
Flagship Pioneering and its founded company ProFound Therapeutics today announced a collaboration to conduct foundational research to identify potential next-generation first-in-class therapies for the treatment of obesity. 12 June 2024
The Health Emergency Preparedness and Response Authority (HERA), part of the European Commission (EC), has selected Australian drugmaker CSL Ltd’s subsidiary CSL Seqirus to provide 665,000 pre-pandemic vaccine doses for 15 European Union and European Economic Area (EEA) member states as well as to the "Union Civil Protection Mechanism" (rescEU). 12 June 2024
Helsinn Group and Chugai Pharma Europe have announced the renewal of their distribution and license agreement for Akynzeo (netupitant-palonosetron) in the UK and Ireland. 12 June 2024
US Senator Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has announced that members will vote next week on whether to subpoena Doug Langa, senior vice president, head of North America operations and president of Novo Nordisk. 12 June 2024
Russia is sharply cutting centralized state purchases of anti-HIV drugs due to the problems with funding and the reduction of supplies to Russia by global drugmakers, reports The Pharma Letter’s local correspondent. 12 June 2024
Genfit, a biopharmaceutical company focused on rare liver diseases, has announced that it has received an Accelerated Approval for Iqirvo (elafibranor). 11 June 2024
The US Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP). 11 June 2024
Biotechnology star-tup Alumis is set to go public, filing with the US Securities and Exchange Commission for an initial public offering (IPO). 11 June 2024
The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to the UK’s political parties ahead of next month’s election. 10 June 2024
Calico Life Sciences, a biotech company specializing in aging and age-related diseases, has had its candidate fosigotifator accepted into the US Food and Drug Administration’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 10 June 2024
British pharma major AstraZeneca's bid to broaden the label for Tagrisso (osimertinib) will be considered under the Priority Review scheme. 10 June 2024
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 10 June 2024
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
The Chinese National Medical Products Administration (NMPA) held a meeting recently to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). 10 June 2024