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
French biotech Abivax has completed an initial public offering (IPO), listing on the Nasdaq global market with 20,325,500 new ordinary shares being issued. 25 October 2023
The US Food and Drug Administration yesterday approved Tibsovo (ivosidenib), from French independent pharm major Servier, for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. 25 October 2023
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma announced. 24 October 2023
Seven vaccine research proposals have been chosen for funding, the latest development in a partnership between the Bill and Melinda Gates Foundation and the National Natural Science Foundation of China (NSFC). 24 October 2023
In October 2022, the US Food and Drug Administration (FDA) released its “Multiple Endpoints in Clinical Trials” document to provide guidance for drug sponsors and other stakeholders regarding best practices in assessment methodologies for medications. 24 October 2023
A new pill for dengue fever developed by US healthcare giant Johnson & Johnson appeared to protect against a form of the virus in a handful of patients in a small human challenge trial in the USA, according to data presented by the company on Friday. 23 October 2023
US pharma major Eli Lilly released five-year outcomes from a pre-planned analysis of the Phase III monarchE study evaluating two years of adjuvant Verzenio (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer. 23 October 2023
The US Food and Drug Administration (FDA) on Friday approved Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years. 23 October 2023
The global pharmaceutical industry is going through a significant shift in the way it operates. Dr Stefanie Lietsch-Dallwig shares her insights on how this shift will impact the local affiliate model in an Expert View piece. 20 October 2023
Californian antiviral specialist Gilead Sciences has presented new data today supporting Sunlenca (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history. 20 October 2023
US pharma giant Pfizer has revealed the cost of its oral antiviral treatment for COVID-19, Paxlovid (nirmatrelvir/ritonavir), once the company starts selling the drug commercially. 20 October 2023
New Jersey, USA-based PTC Therapeutics has announced an agreement with Royalty Pharma to acquire additional royalties on Evrysdi (risdiplam) for $1 billion upfront. 20 October 2023
Swiss drugmaker Basilea Pharmaceutica has entered into an asset purchase agreement with privately owned US firm Gravitas Therapeutics for GR-2397, a clinical-stage antifungal compound with a novel mechanism of action, targeting invasive mold infections caused by Aspergillus species. 20 October 2023
In September, USA-based Ionis Pharmaceuticals (Nasdaq: IONS) unveiled positive Phase III clinical data for olezarsen, a ligand-conjugated antisense (LICA) designed to inhibit apolipoprotein C-III (apoC-III). 20 October 2023
Nearly five months have passed since the Annual Meeting of the American Society of Clinical Oncology (ASCO) took place, and cancer-focused drugmakers are ready once again to dump their data to the world’s oncologists, media and more. 19 October 2023
US biotech major Gilead Sciences has presented new long-term real-world data on its flagship medication Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). 19 October 2023
The GSK majority-owned company ViiV Healthcare is presenting 12-month efficacy, safety and patient-reported outcomes for European participants in the SOLAR study at the Annual European AIDS Conference (EACS) 2023 in Warsaw, Poland. 19 October 2023