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 Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration on Thursday voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. 14 September 2017
Amicus Therapeutics' shares rose 4.4% to $13.87 in morning trading on Wednesday, recovering from a nearly 15% slide pre-market after it revealed disappointing results with its experimental drug for healing wounds related to a rare skin disease. 14 September 2017
The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the USA’s most comprehensive law aimed at shining a light on prescription drug prices, according to local media reports. 14 September 2017
In his second Expert View piece, Yungjoon Kwon, patent/trademark attorney and managing director at law firm Kwon & Kim, considers a South Korean court’s view on one of pharma's hottest topics – dosage regime drugs’ patentability. 14 September 2017
FDA Commissioner Scott Gottlieb will take steps to ensure that the orphan drug designation is used appropriately, with new guidance to be issued on its application. 13 September 2017
The Medicines Discovery Catapult (MDC) is the latest member of the UK’s network of elite, not-for-profit technology and innovation centers. 13 September 2017
New analyses of the landmark EMPA-REG OUTCOME trial showed that Jardiance (empagliflozin) reduced the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular (CV) disease, independent of blood sugar control at the start of the study. 13 September 2017
Privately-owned German pharma company Boehringer Ingelheim has presented new trial results investigating Ofev (nintedanib) with add-on pirfenidone in idiopathic pulmonary fibrosis (IPF). 13 September 2017
US FDA Commissioner Scott Gottlieb says he supports the use of seamless trial design, a game-changing approach to drug development that does away with the long-standing three-phase standard of clinical testing. 13 September 2017
The Phase III STATUS trial of brexanolone has failed to meet its primary endpoint, Massachusetts-based Sage Therapeutics has revealed. 13 September 2017
Although the rate at which investigational drugs received marketing approval in the USA has declined in recent years, the cardiovascular approval rate trailed other drug approvals as a whole, while the time needed to develop cardiovascular drugs rose, according to a recently completed study conducted by the Tufts Center for the Study of Drug Development. 13 September 2017
Sanofi Pasteur, the vaccines division of French pharma major Sanofi, announced today that, for the first time, it is making available its quadrivalent influenza vaccine in the UK. 12 September 2017
In certain adults with type 2 diabetes, Soliqua 100/33 (insulin glargine and lixisenatide injection, 100 Units/mL & 33 mcg/mL) provided blood sugar control earlier and in more adults than those treated with insulin glargine 100 Units/mL alone, according to a new post-hoc analysis of key late-stage clinical trials. 12 September 2017
Fiasp (fast-acting insulin aspart), the only approved, new-generation, ultra-fast acting mealtime insulin, improved overall blood sugar (HbA1c) and post-meal sugar (postprandial glucose or PPG) control over 52 weeks, compared to conventional insulin aspart (NovoRapid), in new study findings. 12 September 2017
Israel’s Teva Pharmaceutical Industries has entered into a definitive agreement under which USA-based CooperSurgical will acquire intrauterine copper contraceptive Paragard, a product within its global Women's Health business. 12 September 2017
Roche stock dropped almost 1.5% yesterday after the cancer giant revealed the Phase III BRIM8 study had missed its primary endpoint of disease-free survival in patients with advanced melanoma. 12 September 2017
German life sciences company Merck KGaA on Sunday became the latest pharma major to back the big data revolution that some believe will transform healthcare. 11 September 2017