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
Swedish biotech Sobi has announced positive results from the AVA-PED-301 study, evaluating the efficacy and safety of Doptelet (avatrombopag). 25 March 2024
The US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil), a single-tablet combination of an endothelin receptor antagonist (ERA), and a phosphodiesterase 5 (PDE5) inhibitor. 25 March 2024
At its March management board meeting, the European Medicines Agency adopted the EMA’s annual report for 2023, noting that, in 2023, Agency recommended 77 medicines for marketing authorization for human use, 39 of which had a new active substance, and adopted the EMA’s annual report for 2023. 23 March 2024
Oslo, Norway-based Photocure said today that it has received notice from medicines regulator Health Canada approving the product monograph for its Cysview (hexaminolevulinate hydrochloride). 22 March 2024
US clinical-stage company OKYO Pharma’s shares rose 5.7% to $1.86 pre-market today, as it announced additional key findings from analyses of the clinical data set from the 240 patient Phase II, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). 22 March 2024
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Swiss rare disease specialist Relief Therapeutics today announced it has granted an exclusive license to Eton Pharmaceuticals or the commercialization of GOLIKE family of products in the USA. 22 March 2024
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older. 22 March 2024
UK pharma major AstraZeneca today released results from the FLAURA2 Phase III trial that showed its Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically-meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 21 March 2024
Seelos Therapeutics, a company working on therapies for amyotrophic lateral sclerosis (ALS) and other central nervous system disorders (CNS) has been struck by a trial failure. 21 March 2024
Since Swiss pharma giant Roche’s Zelboraf (vemurafenib) gained US Food and drug Administration (FDA) approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma. 21 March 2024
A statement from the Centers for Disease Control and Prevention (CDC) in the USA raises concerns about the spread of measles, a public health issue which has affected multiple countries in recent years. 20 March 2024
Italfarmaco has announced that results from its pivotal Phase III EPIDYS trial with givinostat in ambulant boys aged six years and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology. 20 March 2024