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
Generic drugmakers Actavis and Mylan have prevailed in a patent dispute against Warner-Lambert, part of the Pfizer group of companies. 14 November 2018
German science and tech company Merck KGaA was trading nearly 4% higher late on Wednesday as markets digested its third-quarter financial results. 14 November 2018
The European Medicines Agency has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population. 14 November 2018
Research from industry analyst GlobalData highlights progress in developing new therapies for diabetes, while identifying significant areas of unmet need. 14 November 2018
Continuing its prolific deal-making, German family-owned drugmaker Grünenthal says it has acquired the USA-based pharmaceutical company Averitas Pharma, thereby extending its commercial footprint to the USA. 14 November 2018
The USA’s leading pharmacy benefit manager (PBM) has announced that it is introducing a new formulary to provide employers and health plans a better opportunity to leverage changing dynamics to help lower their members' out-of-pocket costs. 14 November 2018
Bayer’s Stivarga (regorafenib) will be subject to a new trial run by The Global Coalition for Adaptive Research (GCAR), called GBM AGILE. 14 November 2018
AbbVie has released new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, Mavyret (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. 14 November 2018
French drugmaker Sanofi has signalled its intention to introduce six innovative drugs and vaccines to the Chinese market “as early as possible.” 14 November 2018
The US Food and Drug Administration yesterday proposed amending its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. 14 November 2018
Rare disease specialist Shire has filed to extend the label for Gattex (teduglutide) in the USA to include pediatric patients with short bowel syndrome (SBS) who are dependent on parenteral support. 13 November 2018
Continuing its divestment program for non-core products, AstraZeneca has announced a second deal within less than a week, with the news lifting its shares 0.89% to 6,306.50 pence. 13 November 2018
Findings presented by Japan’s largest drugmaker Takeda at ISPOR 2018 report that where standards of care are not clearly defined in terms of cost or outcomes, the ability of payers to accurately estimate the cost effectiveness of new therapeutic options can be hindered. 13 November 2018
Germany’s Bayer has provided an upbeat third quarter financial results statement, showing sales of pharmaceuticals rose by 4.8% to 4.2 billion euros ($4.7 billion). 13 November 2018
Novartis has released new data on its already marketed Entresto (sacubitril and valsartan), which so far has failed to reach sales expectations, that will give it a positive edge in the treatment of heart failure patients, pushing the firm’s shares up 0.76% to 89.76 Swiss francs in early trading. 13 November 2018
The global market for drugs to treat myeloproliferative disorders is expected to be valued at $9.26 billion by 2023, expanding at a compound annual growth rate (CAGR) of 3.4% during the forecast period. 13 November 2018
Prices for drugs in Russia may rise significantly as soon as the beginning of 2019, according to recent statements by an official spokesman of the Russian Pharmacy Guild, a public association, which unites Russian leading pharmacies and some local drugmakers, reports The Pharma Letter’s local correspondent. 12 November 2018
Amarin has announced primary results from a trial of Vascepa (icosapent ethyl) which show a 25% relative risk reduction (RRR), including 20% reduction in cardiovascular death. 12 November 2018
Top-line results from the first two cohorts of its Phase IIa trial evaluating investigational treatment CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss, have been released today. 12 November 2018