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
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting. 24 March 2018
Shingrix, which was first approved in Canada in October last year, followed by the USA later the same month, has now added two more important regions were the vaccine is cleared for marketing. 23 March 2018
Anglo-Swedish pharma major AstraZeneca yesterday announced that the European Commission has granted marketing authorization for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalemia. 23 March 2018
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Ozempic (semaglutide), a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1), for the treatment of adults with type 2 diabetes. 23 March 2018
Swiss pharma giant Novartis got a boost late yesterday with an additional indication for its already blockbuster drug to treat children with a rare form of leukemia. 23 March 2018
In a reversal of last week’s decision to reject so-called ‘right to try’ legislation, the US House of Representatives has now given the green light to a bill which would enable terminally ill patients in the USA to gain access to unapproved drug candidates. 22 March 2018
While there is plenty of doom and gloom about the current cost of developing drugs and low returns on investment in R&D, a new report highlights that big-selling drugs are still set to enter the market in 2018, and in record numbers. 22 March 2018
Shares in Japanese drugmaker Chugai Pharmaceutical are up almost 5% on news that the China Food and Drug Administration (CFDA) is to consider the firm’s regulatory application for eldecalcitol, an osteoporosis treatment marketed in Japan as Edirol. 22 March 2018
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Drug designation to gilteritinib for the treatment of FLT3mut+ acute myeloid leukemia (AML), the drug’s prospective indication. 22 March 2018
US drugmaker Titan Pharmaceuticals has entered into a definitive asset purchase, supply and support agreement with privately-held Italian firm L Molteni & C, through which Molteni has acquired the European intellectual property related to Probuphine (buprenorphine). 22 March 2018
After 19 years with the US healthcare giant Johnson & Johnson (NYSE: JNJ), Dominic Caruso, executive vice president, chief financial officer, has elected to retire in September 2018. 22 March 2018
Pradaxa (dabigatran etexilate) has had its safety profile strengthened by new data from one of the largest real-world studies of its kind. 21 March 2018
Ogilvy Healthworld's fourth annual report analyzing social media usage across pharma reveals that Novo Nordisk, Johnson & Johnson and Novartis are leading the charge. 21 March 2018
Christine Roy-Duval has left her role as international clinical investigation director at French pharma major Sanofi’s diabetes unit to join metabolic diseases specialist Valbiotis. 21 March 2018
The UK business of Akcea Therapeutics has received a positive scientific opinion for volanesorsen, from the country’s Early Access to Medicines Scheme (EAMS). 21 March 2018
Swedish Orphan Biovitrum says that, after securing reimbursement in Europe for Ravicti (glycerol phenylbutyrate), the company is launching the therapy in several country markets. 21 March 2018
The Australian government is taking a critical step in helping end the transmission of HIV infection in Australia with the April 1 listing of tenofovir with emtricitabine on the Pharmaceutical Benefits Schedule (PBS), said Health Minister Greg Hunt. 21 March 2018
Helsinn Pharmaceuticals has entered into a definitive agreement to acquire worldwide rights to Valchlor/Ledaga, (mechlorethamine/chlormethine), an alkylating agent for the topical treatment of mycosis fungoides‐type cutaneous T‐cell lymphoma (MF-CTCL). 21 March 2018