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
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
USA-based rare disease Applied Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of classic galactosemia 28 February 2024
Riding high after a high-profile victory over erstwhile US President Donald Trump, New York Attorney General Letitia James has set her sights on another emotive issue - the safety of certain medicines given to children. 28 February 2024
Indian drugmaker Cipla Limited says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India. 28 February 2024
Belgium’s largest drugmaker UCB today reported earnings results for the full year ended December 31, 2023 with a downturn on sales and earnings, but demonstrating significant achievements and sending its shares up 3.5% to 100.50 euros. 28 February 2024
Shares of biotech FibroGen leapt 14.6% to $2.12 by close of trading Tuesday, after it announced a deal with UK pharma major AstraZeneca for roxadustat would be terminated. 28 February 2024
French ophthalmology company Nicox has announced it will replace its chief executive, Andreas Segerros, with current chief business officer Gavin Spencer. 28 February 2024
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Antiviral specialist Gilead Sciences has announced a new approval from the US Food and Drug Administration, for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 27 February 2024
USA-based Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing treatments for hair loss, has closed a $16.75 million Series A financing. 27 February 2024
The US Food and Drug Administration (FDA) has approved the marketing application for Exblifep (cefepime/enmetazobactam), submitted by Franco-German firm Allecra Therapeutics. 27 February 2024