Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
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
Research from industry analyst GlobalData underscores the dominance of two players in the cystic fibrosis (CF) space - Vertex Pharmaceuticals and AbbVie. 2 September 2021
Shares of Futura Medical moved higher yesterday, as it announced that it has entered into a licensing agreement with m8 Pharmaceuticals, a specialty biopharmaceutical company focused on commercialization in Latin America, for the rights to exclusively develop and commercialize the company's topical, gel-based erectile dysfunction (ED) treatment MED3000, in Brazil and Mexico. 1 September 2021
Teva Pharmaceutical Industries and its partner MedinCell have announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for schizophrenia has been accepted by the US Food and Drug Administration (FDA). 1 September 2021
Johnson & Johnson’s pharmaceutical arm, Janssen, has announced results from a post-hoc pooled analysis of the Phase III GRIPHON and Phase IIIb TRITON studies. 31 August 2021
Japanese pharma major Eisai has concluded a license agreement concerning dotinurad, a treatment for hyperuricemia and gout discovered by Fuji Yakuhin, for development and distribution in five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand. 31 August 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). 31 August 2021
Daiichi Sankyo has concluded an agreement on commercialization collaboration in Japan with the local subsidiary of US pharma major Eli Lilly for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines. 31 August 2021
The protection of intellectual property (IP) rights currently remains one of the most pressing problems for global drugmakers operating in the Russian market, according to recent statements by Oksana Monzh, general director of French pharma major Sanofi in the Eurasian Region and representatives of other producers. 31 August 2021
Following a positive opinion from the European Medicines Agency’s human health committee in June, the European Commission (EC) has rubber-stamped its marketing authorization for Voxzogo (vosoritide), a once daily injection to treat achondroplasia in children from the age of two until growth plates are closed, which occurs after puberty when children reach final adult height. 28 August 2021
Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that Jardiance (empagliflozin) showed an impressive 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo. 28 August 2021
The Food and Drug Administration recently approved a new indication for Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of patients with idiopathic hypersomnia (IH), a rare neurologic disorder that can result in daytime sleepiness despite having a prolonged night sleep. 27 August 2021
Eva Marchese, Abhishek Kumar and Kees Chamberlain from Charles River Associates examine how the COVID-19 pandemic is expected to impact payers’ management of pharmaceutical budgets in Europe in an Expert View column. 26 August 2021
Merck & Co has released positive top-line results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of its next-gen pneumococcal vaccine Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in healthy infants enrolled between 42-90 days of age (n=1720). 26 August 2021
The hematological (blood) cancer therapy market is diverse and highly genericized, with chemotherapies currently accounting for the highest number of marketed drugs. 26 August 2021
Servier Pharmaceuticals, the US subsidiary of French drugmaker Servier, has won approval for Tibsovo (ivosidenib) in cholangiocarcinoma, a rare and aggressive form of cancer. 26 August 2021
Bain Capital has sold its 42.9%-plus convertible bonds in Kosdaq-listed botulinum toxin maker Hugel, reported the Korea JoongAng Daily and other media. 26 August 2021