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
In the USA, a New York jury on Thursday found that Israel-based Teva Pharmaceutical Industries’ US subsidiary contributed to a crisis of opioid abuse in the Empire State, but also placed a small portion of the blame for the epidemic on the state. 31 December 2021
The Russian Ministry of Health has officially presented a draft federal program to combat mortality from hepatitis C in Russia – a state program, adoption of which has been lobbied for by the patient community in Russia since 2011, reports The Pharma Letter’s local correspondent. 29 December 2021
Russia will simplify the procedure for imports of unregistered drugs against serious diseases starting from March of next year, according to recent statements by state authorities and local media reports. 28 December 2021
Russian drugmaker ChemRar Group says that its Avifavir (favipiravir) drug is effective against various variants of SARS-CoV-2 (coronavirus), including Delta and Omicron, as it affects the highly conservative and mutation-resistant replication systems of RNA virus (RdRp) via three complementary mechanisms, resulting in complete blockade of the viral infection. 27 December 2021
Japanese drug major Chugai Pharmaceutical today announced that it signed a joint research agreement with the Nation al Cancer Center Japan (NCC) and participated in an Asian multicenter prospective study A-TRAIN, which is led by NCC Hospital. 27 December 2021
US cancer-focussed firm Karyopharm Therapeutics has entered into an exclusive licensing agreement whereby privately-held Italian drugmaker Menarini will commercialize Nexpovio (selinexor), Karyopharm’s first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in Europe and other key global territories. 24 December 2021
A new supply agreement between the research-based biopharmaceutical industry and the State will improve patients’ access to the latest innovative medicines, according to the Irish Pharmaceutical Healthcare Association (IPHA), the representative organization for medicines innovators. 24 December 2021
A new strategic research tie-in between Aarvik Therapeutics and ArriVent Biopharma will see the firms working together to develop an undisclosed oncology-focused drug candidate. 24 December 2021
Johnson & Johnson’s pharma arm Janssen has won a positive reimbursement decision in the UK, from the country’s health technology assessor. 24 December 2021
Following an Antimicrobial Drugs Advisory Committee narrow vote of 13-10 last month in favor of the anitviral’s benefits, the US Food and Drug Administration today issued an emergency use authorization (EUA) for Merck & Co’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for pharma giant Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
Bipolar disorder is a mental disorder characterized by periods of mania and depression. While there are a high number of treatments that can effectively manage the acute mania, there is a striking lack of treatments for bipolar depression, with this unmet need set to be only partially met over the next decade. 23 December 2021
Japan’s largest drugmaker Takeda Pharmaceutical yesterday announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. 22 December 2021
Research from British online pharmacy Chemist4U has revealed some insights on the current state of prescriptions in England, including the most prescribed medicines in the country. 22 December 2021
French vaccines developer Valneva has announced positive top-line results from the lot-to-lot Phase III trial of its single-shot chikungunya vaccine candidate, VLA1553. 22 December 2021
Russia is faced with a significant delay of drug supplies to the domestic market, as producers delay signing of contracts with the local state in an attempt to make a deal with higher prices for them, according to a recent report published by the Institute of State and Municipal Administration of the Higher School of Economics (ISMU), one of Russia’s leading research institutions in the field of finance, reports The Pharma Letter’s local correspondent. 22 December 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced that Apretude (cabotegravir), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually-acquired HIV-1, has been approved in the USA. 21 December 2021
Topical dermatology specialist DermBiont has raised $28 million in a series A financing, at the same time as acquiring clinical-stage biotech Chromaderm. 21 December 2021
German pharma and life sciences group Merck KGaA today announced a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine (marketed as Mavenclad for multiple sclerosis) for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 20 December 2021