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 China subsidiary of French pharma major Sanofi on October 8 signed a strategic agreement with the Association of County Hospital President, a government -backed organization aiming to improve clinical practices in China’s rural areas, reports The Pharma Letter’s local correspondent Wang Fangqing. 11 October 2018
The three Japanese drugmakers that launched a program a year ago to discover new treatments using a drug-repositioning compound library have started a second recruitment round to find new researchers. 10 October 2018
Swedish startup Lobsor has won its first approval for Lecigon (levodopa/carbidopa/entacapone), a new therapeutic system for symptomatic treatment of advanced Parkinson’s disease, a decision which could shake up a market dominated by AbbVie. 10 October 2018
Shares in Affimed have fallen more than a quarter since the firm announced it was putting on hold development of AFM11, after the occurrence of Serious Adverse Events (SAEs) in three patients. 10 October 2018
The market value of US biopharma Trevena is worth just a third of its worth at Monday’s close after a US Food and Drug Administration (FDA) report raised concerns with its opioid injection to treat acute pain. 10 October 2018
Incoming Pfizer chief executive Albert Bourla is to stamp his mark firmly on the company’s leadership, as the firm announced a new executive team ready to clock on from the commencement of his tenure next year. 10 October 2018
American PARP inhibitor specialist Clovis Oncology will present four posters related to the Rubraca (rucaparib) development program at the 2018 European Society of Medical Oncology congress. 10 October 2018
Tokyo’s Eisai will provide clinical updates regarding its selective TKI Lenvima (lenvatinib), also marketed as Kisplyx, at the forthcoming annual meeting of the European Society for Medical Oncology (ESMO). 10 October 2018
The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on October 1, 2018, as announced at the beginning of August 2018. 10 October 2018
Zug, Switzerland-based oncology specialist Tesaro says it will present six abstracts at the upcoming annual meeting of the European Society for Medical Oncology (ESMO) in Munich, Germany. 10 October 2018
Ireland-headquartered generic and OTC drugmaker Perrigo, which recently said it was restructuring into two separate units, has announced the appointment of Murray Kessler as president, chief executive and member of the board of directors, effective immediately. 10 October 2018
The Russian government plans to provide access to imported drugs that have not undergone clinical trials within Russia, according to recent statements by some senior officials of the Russian Ministry of Health. 10 October 2018
Dr Martin Huber, chief medical officer of Tesaro, spoke with The Pharma Letter about his firm’s runner in the PARP blocker field, Zejula (niraparib). 9 October 2018
A leading British clinical research organization (CRO), Richmond Pharmacology, has published a detailed report criticizing current UK immigration policy and supporting proposals to install a skills-based migration system after Brexit. 9 October 2018
During the third quarter, pharmaceutical pricing dynamics remained under scrutiny. Specifically, regulators have highlighted the elimination of rebates as a way to protect consumers since patients' out-of-pocket expenses are influenced by the list, rather than net, price of each therapy. 9 October 2018
A final report from the Institute for Clinical and Economic Review (ICER) finds that the pricing of new therapies for the treatment of hereditary transthyretin amyloidosis (hATTR) “far exceeds commonly cited thresholds for cost effectiveness.” 8 October 2018
Over the past 24 months, the Latin American cannabis industry has emerged from the shadows to command the attention of the international cannabis community as over ten major markets have legalized medical cannabis. 8 October 2018