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
Austrian drug developer Marinomed Biotech has entered a new collaboration and licensing agreement with Chinese drugmaker Luoxin Pharmaceutical Group. 21 October 2021
Italian ophthalmics company SIFI has announced positive results from a Phase III study of its polihexanide-based therapy for people with acanthamoeba keratitis (AK). 20 October 2021
Following recent discussions with the US regulator, Sage Therapeutics and partner Biogen said yesterday they plan to submit a New Drug Application (NDA) to the US Food and Drug Administration for zuranolone (SAGE-217), an investigational two-week, once-daily therapeutic, in the second half of 2022. 20 October 2021
Japanese drugmaker Sumitomo Dainippon Pharma and Nashville, USA-based BehaVR have signed definitive agreements to develop and commercialize both prescription digital therapeutics and general wellness products for treatment of social anxiety disorder (SAD), generalized anxiety disorder (GAD), and major depressive disorder (MDD) with the goal of bringing much needed tools to tackle the escalating global anxiety and depression crisis. 20 October 2021
US health care giant Johnson & Johnson today was the first pharma to report third-quarter 2021 financials, noting that group sales for the period were up 10.7% at $23.34 billion, but missed analysts’ expectations of $23.72 billion. 19 October 2021
AI-driven drug combo specialist Pharnext saw its shares leap nearly a tenth in morning trading on Tuesday, after a positive result from the Phase III PLEO-CMT trial. 19 October 2021
Californian precision oncology company Calithera Biosciences has padded its pipeline with two assets from Japanese giant Takeda Pharmaceutical. 19 October 2021
The Russian government has officially presented a new state program for the development of the domestic pharmaceutical industry for the next 10 years - "Pharma-2030," reports The Pharma Letter’s local correspondent. 19 October 2021
US pharma giant Merck & Co and Ridgeback Biotherapies’ investigational oral antiviral molnupiravir that reduced the risk of hospitalization or death by approximately 50% compared to a placebo has got five Indian companies rushing to collaborate on the oral antiviral medicine. 19 October 2021
Shares of USA-based antibacterial products developer Entasis Therapeutics were up 27% at $3.95 pre-market, as the company announced positive top-line results from its ATTACK trial - a global Phase III registrational trial evaluating the safety and efficacy of sulbactam-durlobactam (SUL-DUR) versus colistin in patients with infections caused by Acinetobacter baumannii. 19 October 2021
A positive reimbursement decision in the UK will see patients in England and Wales gain access to Boehringer Ingelheim’s Ofev (nintedanib) through the country’s national healthcare provider. 18 October 2021
Physics-based US software specialist Schrödinger and Centessa Pharmaceuticals, together with the latter’s subsidiary Orexia Therapeutics, today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R). 18 October 2021
China’s Center for Drug Evaluation (CDE), a division under the Chinese drug industry watchdog the National Medical Products Administration (NMPA), has been churning out guidelines in the past year to help the nation transform from a generics/biosimilar maker into a novel drug development hub, reports The Pharma Letter’s local correspondent. 18 October 2021
Oyster Point Pharma saw its shares gain almost 12% to $15.30 pre-market today, as it revealed that the US the Food and Drug Administration has approved Tyrvava (varenicline solution) Nasal Spray 0.03mg for the treatment of the signs and symptoms of dry eye disease. 18 October 2021
Irish pharmaceuticals trade group the IPHA has welcomed the provision of 30 million euros ($35 million) for new medicines in the Government’s recent budget. 18 October 2021
Highlighting research presented at the Infectious Diseases Week (IDWeek) annual congress, Brighton, UK-based biotech Destiny Pharma says there is “strong support” for the use of its XF-73 nasal product. 18 October 2021
Starting this week, Brazil’s Oswaldo Cruz Foundation (Fiocruz) will be part of a Phase III international multicenter study with the drug molnupiravir. 18 October 2021
New European Union (EU) regulation requires life sciences companies’ data in the clinical trial master file (TMF) to remain secure, accessible, and usable for a period of 25 years. 15 October 2021
USA-based NRx Pharmaceuticals has announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil (vasoactive intestinal peptide [VIP] with the proposed trade name Zyesami) for the treatment of respiratory failure in patients with Critical COVID-19. 15 October 2021