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
Japanese pharma major Astellas today presented 24-week results from the Phase IIIb DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, at the 15th Congress of the European Society of Gynecology (ESG) in Amsterdam. 30 November 2023
Boston, USA-based biopharma Karuna Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults. 30 November 2023
Several Latin American countries, given their processes of political change, are immersed in deep discussions about transforming their health systems, writes The Pharma Letter's local correspondent. 29 November 2023
As political leaders from around the world get ready to meet at the COP 28 climate conference, life science companies are taking steps to encourage sustainability within industry. 29 November 2023
Industry lobbyist Pharmaceutical Research and Manufacturers of America (PhRMA) has criticized greater use of prior authorization in Medicaid. 29 November 2023
Swiss pharma giant Roche will resume the supply of its cystic fibrosis drug Pulmozyme (dornase alfa), as the company has found the way for its imports to the Russian market, The Pharma Letter’s local correspondent reports. 29 November 2023
US pharma giant Merck & Co has announced results from STRIDE-3, a Phase III trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. 28 November 2023
India's Draft Patents (Amendment) Rules, 2023, that propose several changes to India's patent regime, have raised significant concerns among public health experts, domestic drug industry chiefs, and civil society organizations. 28 November 2023
US clinical-stage drug developer Ensysce Biosciences and Sweden’s OncoZenge have signed a letter of intent (LoI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge in the USA. 28 November 2023
Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics for its dry eye candidate reproxalap. 28 November 2023
Russia will significantly reduce public procurements of anti-cancer drugs which are not included in the list of vital drugs due to the lack of funds, reports The Pharma Letter’s local correspondent. 28 November 2023
In the USA, the Biden Administration is currently conducting a government-wide review of the use of “march-in” authority under the Bayh-Dole Act. 28 November 2023
US ophthalmic drug developer Ocuphire Pharma has announced the appointment of Joseph (Joe) Schachle into the newly created role of chief operating officer (COO), effective today. 27 November 2023
Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023
Australian dermatology specialist Botanix Pharmaceuticals saw its shares dip 3.2% to A$0.15 this morning, despite announcing receipt of firm commitments for $13.5 million (US) via an institutional placement, with proceeds to support preparation for commercial launch activities for its lead product Sofdra (sofpironium bromide) gel. 27 November 2023