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
Swiss biotech Myovant Sciences has launched Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in the USA. 6 January 2021
Despite dealing with the urgent need to evaluate vaccines, drugs and diagnostics tests relating to the COVID-19 pandemic, the US Food and Drug Administration cleared a bumper number of novel drugs last year. 6 January 2021
The US regulator has accepted the New Drug Application for Priority Review submitted for Farxiga (dapagliflozin), raising hopes the diabetes med could become the first SGLT2 inhibitor for people with chronic kidney disease (CKD), with and without type 2 diabetes. 6 January 2021
The US. Food and Drug Administration has accepted for priority review the New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. 6 January 2021
Japanese drugmaker Daiichi Sankyo says it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for teserpaturev (G47∆), an oncolytic virus, for the treatment of patients with malignant glioma. 5 January 2021
Shares in Californian cancer drug specialist Calithera Biosciences have fallen by half, following bad news from the CANTATA clinical study of telaglenastat. 5 January 2021
Onureg (azacytidine tablets), the Bristol Myers Squibb drug approved in the USA last year for the continued treatment of patients in first complete remission with acute myeloid leukemia (AML), has been given an airing in the New England Journal of Medicine (NEJM). 5 January 2021
Shares of Japan’s Sosei Group closed down 3.3% at 1,711 yen today, after it revealed it is to regain the worldwide rights to previously out-licensed muscarinic agonist programs. 5 January 2021
Leading Russian drugmakers, as well as global pharmaceutical producers, operating in Russia fear of the possible collapse of the local pharmaceutical market after February, 1 2021 – the date, when the simplified period of work of a drug labelling system ends, reports The Pharma Letter’s local correspondent. 5 January 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has formally launched the Innovative Licensing and Access Pathway (ILAP). 4 January 2021
Zydus Cadila, a part of Cadila Healthcare, on Sunday announced that it will be starting Phase III clinical of ZyCoV-D, its plasmid DNA vaccine to prevent COVID-19, after having received permissions from the Drugs Controller General of India (DCGI). 4 January 2021
The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. 31 December 2020
A COVID-19 vaccine developed by an affiliate of state-backed pharmaceutical firm Sinopharm was approved for widespread use in China on Thursday, it has been widely reported. 31 December 2020
Two US district courts – Maryland and the Northern District of California - recently dealt what may become fatal blows to the Trump administration’s Most Favored Nation (MFN) rule for Medicare Part B drug payment on procedural grounds, according to a posting on Hyman, Phelps & McNamara’s (HP&M) FDA Law Blog. 31 December 2020
Hutchison China MediTech, a Chinese company also known as Chi-Med, has announced that surufatinib has been granted approval for the treatment of non-pancreatic neuroendocrine tumors (NETs) in its home country. 30 December 2020
Chinese company Hutchison China MediTech has initiated the filing of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for surufatinib. 29 December 2020
US drugmaker Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Zeposia (ozanimod) for the treatment of moderately to severely active ulcerative colitis (UC). 29 December 2020