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 US Food and Drug Administration (FDA) has issued a new draft guidance on its assessment of the benefit-risk of opioid pain medications amid the addiction crisis in the USA. 21 June 2019
Georgia, USA-based ophthalmic specialist Alimera has won a positive reimbursement decision in the UK, for its therapy Iluvien (fluocinolone acetonide). 20 June 2019
Now that the warming Spanish sun has gone down on EULAR 2019, it’s worth considering what emerged of note from some of rheumatology’s leading players at the event in Madrid. 20 June 2019
US drugmaker Karyopharm Therapeutics has reported updated results from the Phase IIb SADAL study of selinexor at the International Conference on Malignant Lymphoma (ICML) in Switzerland. 20 June 2019
US antibiotics specialist Melinta Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) for priority review. 19 June 2019
In a boost for its medicines portfolio in Japan, AstraZeneca has gained regulatory approval for not one, but three products, the Anglo-Swedish pharma major announced today. 19 June 2019
Japanese drugmaker Eisai has announced that a joint research group comprising its scientists and Yoshito Kishi’s group at Harvard University has achieved a total synthesis of halichondrin. 19 June 2019
The global anti-obesity prescription drugs market is likely to rise at a 4.80% compound annual growth rate (CAGR) over the forecast duration from 2017 to 2026. The market is projected to be worth $1,000 million by 2026-end, according to a new report from Transparency Market Research. 19 June 2019
Shionogi has announced the approval for Intuniv (guanfacine hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD) with an additional indication in adult patients in its domestic market. 18 June 2019
Shares in UK-based drugmaker AstraZeneca were up over 1% in early trading on Tuesday morning, after the firm announced European approval for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. 18 June 2019
The US Food and Drug Administration on Monday approved Victoza (liraglutide) injection for the treatment of pediatric patients aged 10 years or older with type 2 diabetes, under a priority review evaluation. 18 June 2019
At the meeting of the European Medicines Agency’s (EMA) management board last week, the topic of the move to Amsterdam and its impact on business and staff, along with other Brexit-related business, dominated the agenda. 17 June 2019
US drug major AbbVie and Swiss pharma giant Novartis are the latest to announce production and launch plans in Russia, reports The Pharma Letter’s local correspondent. 17 June 2019
Valo Therapeutics, a cancer immunotherapy company developing neoantigen-coated oncolytic viruses as therapeutic vaccines, has appointed Dr Michael Stein to the full-time role of chief executive, having served as part-time co-chairman since inception in January 2017. 17 June 2019
Last month, the US Department of Health and Human Services (HHS) announced a new rule demanding that direct-to-consumer television advertisements for certain pharmaceuticals and biologics state the list price of the medicine being advertised. 17 June 2019
This month we delve into the diagnosis and treatment of Friedreich’s Ataxia (FA), a rare inherited genetic disorder affecting approximately one to two people per 50,000.1,2 Pharma’s role in advancing the care of these patients is also explored by Dr Nicola Davies in her exclusive series for The Pharma Letter. 17 June 2019