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
The US Food and Drug Administration (FDA) is working closely with Pfizer to assess the impact of the damage at its facility at Rocky Mount, North Carolina. 24 July 2023
Obesity is one of the most urgent health challenges of our time. With more than half the global population estimated to be either overweight or living with obesity in the next twelve years and the cost of the condition is predicted to soar to $4.3 trillion, there is no question that innovative weight loss solutions will significantly contribute to the sustainability of the healthcare sector. 24 July 2023
Californian antiviral specialist Gilead Sciences has revealed new analyses for its flagship medication Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 24 July 2023
A drug shortage is defined by the Federal Food, Drug, and Cosmetic (FD&C) Act as a period of time when the demand or projected demand for a drug in the US exceeds its supply.1 22 July 2023
Announcing a range of cost-cutting measures, the chief executive of Swiss biotech Idorsia has said it will take “longer than originally planned” for Quviviq (daridorexant) to become a commercial success. 21 July 2023
Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines. 21 July 2023
The Indian government is to make 'Schedule M' compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing, to help in quality assurance and also reduce compliance burden in the pharmaceutical sector. 20 July 2023
The US Federal Trade Commission and the Department of Justice have released a draft update of the Merger Guidelines, which describe and guide the agencies’ review of mergers and acquisitions to determine compliance with federal antitrust laws. 20 July 2023
Not surprisingly given the negative opinion from the European Medicines Agency’s (EMA) human medicines committee (CHMP), the European Commission has followed guidance and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). 20 July 2023
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
Negotiations over the future of drug pricing in the UK are off to a rocky start, as the UK government seeks to sustain the high rebate rates in the current statutory regime. 20 July 2023
A new analysis of clinical research into selinexor suggests it could be an effective maintenance therapy for certain people with endometrial cancer. 19 July 2023
Leading Russian patient communities have once again called on the state to increase public procurements of HIV drugs – in a move to prevent the risks of a shortage of antiretroviral (ARV) drugs in the second half of 2023, reports The Pharma Letter’s local correspondent. 19 July 2023
A finger prick blood test shows promise in the ability to detect Alzheimer’s disease, according to research reported for the first time today at the Alzheimer’s Association International Conference (AAIC) 2023. 19 July 2023
Brighton, UK-based infectious disease specialist Destiny Pharma today announced that Chris Tovey will join the company as chief executive (CEO) on September 1, 2023. 19 July 2023
The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. 19 July 2023