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
Testicular cancer can be prevented from coming back using half the amount of chemotherapy that is currently used, a new clinical trial has shown. 2 January 2020
The US Food and Drug Administration has released a full list of its drug approvals for 2019, showing a total of 48 positive decisions from the Center for Biologics Evaluation and Research (CDER). 31 December 2019
Savara Pharmaceuticals has announcemed that the US Food and Drug Administration has granted Breakthrough Therapy designation for Molgradex, its inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). 31 December 2019
Mene Pangalos, one of the leaders behind AstraZeneca’s remarkable recent record of successful drug development, has been awarded a knighthood. 31 December 2019
Eli Lilly on Monday announced that the US District Court for the Southern District of Indiana ruled in favor of Lilly that the lung cancer drug Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in May 2022. 31 December 2019
The Russian nuclear monopoly Rosatom has announced plans to establish production of anti-cancer drugs in the South Urals of the country, reports The Pharma Letter’s local correspondent. 30 December 2019
The Ukranian pharmaceutical market is expected to grow by 15% up to $3.3 billion in value terms this year, that will be the highest figure among the markets of other post-Soviet states, according to recent statements by some leading Ukranian analyst agencies in the field of pharmaceutics and local media reports. 30 December 2019
The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new European Medicines Agency (EMA) building in Amsterdam Zuidas in January 2020. 30 December 2019
Japanese pharma major Eisai on Friday announced that JAMA Network Open (www.jamanetwork.com) published results of SUNRISE 1 (Study 304), a pivotal Phase III head-to-head study that compared its just US-approved Dayvigo (lemborexant) to placebo and an active comparator in patients with insomnia disorder that showed the therapy significantly improved both sleep onset and sleep maintenance compared with placebo. 30 December 2019
The Netherlands’ Medicines Evaluation Board (MEB) is increasing the fee rates for authorization applications, authorization changes and the annual fees of human medicinal products. 27 December 2019
Cancer-focused Karyopharm Therapeutics has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking accelerated approval for Xpovio (selinexor), the company’s first-in-class, oral selective inhibitor of nuclear export (SINE) compound. 27 December 2019
Amid the ongoing stagnation of the Russian pharmaceutical market, local drugmakers have significantly increased exports of their drugs, according to recent statements, made by representatives of some leading local pharmaceutical producers and industry analysts, reports The Pharma Letter’s local correspondent. 24 December 2019
The US Food and Drug Administration yesterday approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. 24 December 2019
The US Food and Drug Administration has approved the New Drug Application (NDA) for the orexin receptor antagonist Dayvigo (lemborexant), ahead of the Prescription Drug User Fee Act (PDUFA) date set for December 27, 2019. 23 December 2019
The World Health Organization (WHO) has just quality assured a third pneumococcal conjugate vaccine (PCV), Pneumosil, manufactured by the Serum Institute of India, that protects children against certain types of pneumonia and will be much more affordable than existing vaccines. 23 December 2019
AstraZeneca today announced that it has agreed to sell the commercial rights to Arimidex (anastrozole) and Casodex (bicalutamide) in a number of European, African and other countries to French company Juvisé Pharmaceuticals. 20 December 2019
Indian drugmaker Glenmark Pharmaceuticals says that partner Seqirus has received marketing approval for Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]) from Australia’s Therapeutic Goods Administration (TGA), Australia. 20 December 2019
The Johnson & Johnson unit Janssen has announced that the European Commission (EC) has approved an indication for Spravato (esketamine), the first antidepressant medicine with a new mechanism of action in more than 30 years. 20 December 2019
Just a couple of days after filing for approval of the drug as a treatment small cell lung cancer (SCLC) with the US Food and Drug Administration, Spain’s PharmaMar has signed an important licensing deal for Zepsyre (lurbinectedin). 20 December 2019