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 World Health Organization (WHO) has drawn attention to a new report illustrating the value of pre-exposure prophylaxis (PrEP) services around the world. 12 December 2019
The UK’s National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) have published positive appraisals recommending the use of Mulpleo (lusutrombopag) by the National Health Service (NHS) in England, Wales and Scotland for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing planned invasive procedures, Japanese drug major Shionogi. 12 December 2019
Anglo-Swedish company AstraZeneca and its Japanese partner Daiichi Sankyo have presented new data on their breast cancer candidate trastuzumab deruxtecan, which the companies believe could establish a new standard of care. 12 December 2019
Following a negative US Food and Drug Administration advisory panel regarding its cardio drug Brinavess (vernakalant), US specialty pharma company Correvio Pharma today announced plans to explore strategic options to maximize stakeholder value. 11 December 2019
Spain’s leading drugmaker Almirall has announced the publication of long-term safety data from a 40-week, Phase III open-label extension study of Seysara (sarecycline) in patients nine years of age and older. 11 December 2019
Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030. 11 December 2019
House Democrats announced on Monday they have reached a deal with the White House on the trade agreement with Canada and Mexico, bringing President Donald Trump closer to fulfilling a major legislative accomplishment, a revamp of the old NAFTA that Mr Trump scrapped, and a fulfillment of a key campaign promise by the president, reported CBS News and other media. 11 December 2019
The Russian government has officially approved a new procedure for commercialization of drugs in the national pharmaceutical market, according to recent statements made by some senior state officials of the Russian Ministry of Health and local analysts, reports The Pharma Letter’s local correspondent. 11 December 2019
At the annual meeting of the American Society of Hematology (ASH), French drugmaker Sanofi presented positive data for ex-Bioverativ asset sutimlimab. 11 December 2019
Shares of Solasia Pharma shot up 33.3% to 200 yen by close of trading today, after revealing that it has entered into an exclusive license agreement with fellow Japan-based Maruho for commercialization of Solasia’s product SP-04 (PledOx). 11 December 2019
A key advisory panel at the US Food and Drug Administration has recommended against approving heart med Brinavess (vernakalant hydrochloride), voting 11 against and two in favor. 11 December 2019
Forendo Pharma, a Finland-based clinical-stage drug development portfolio company of Karolinska Development, today announced signing of a license and collaboration agreement with Swiss pharma giant Novartis. 11 December 2019
Katy Wallace, principal consultant in the Life Sciences Practice at executive search firm, Berwick Partners, explains why the pharma industry needs diverse leadership in an Expert View piece. 10 December 2019
At the 2019 ASH annual meeting, Bristol-Myers Squibb has announced positive results from the QUAZAR AML-001 study of an experimental oral hypomethylating agent, CC-486. 10 December 2019
French pharma major Sanofi was trading 5% higher as Tuesday’s activity entered its final hour, after the company announced a new strategy. 10 December 2019
There were mixed conclusions from the US Institute for Clinical and Economic Review (ICER) newly-released Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of Danish diabetes giant Novo Nordisk’s oral semaglutide, branded Rybelsus, a GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). 10 December 2019
Cambridge, UK-based Cresset Discovery Services, a contract research organization for early phase discovery, has sold rights to the candidate RP0217, to the Narayana Nethralaya Foundation (NNF). 10 December 2019