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
Be they about boosting generics, advancing gene therapies or other aspects of the drug development and manufacturing industry that it is trying to improve, announcements have been coming thick and fast from the US Food and Drug Administration (FDA). 13 July 2018
Japan’s largest drugmaker Takeda Pharmaceutical and Netherlands-based Norgine have agreed to terminate the license and development agreement for the development, manufacture and sale in Japan of Oblean (cetilistat), a drug for the treatment of obesity, as of October 13, 2018. 13 July 2018
After many years of litigation from cancer patients, a court in Missouri, USA, has ordered healthcare giant Johnson & Johnson to pay an eye-watering $4.7 billion in damages to 22 women who allege harm caused by products containing talc. 13 July 2018
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) at its meeting on Thursday voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older. 13 July 2018
Andrew Rut, chief executive of MyMeds&Me, writes an Expert View piece on Japanese openings for tech-based pharmacovigilance firms in the wake of regulatory changes. 12 July 2018
When it comes to reducing the cost of prescription medicines, where President Trump has increasingly failed, a new price transparency law in California appears to be succeeding. 12 July 2018
Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programs. 12 July 2018
A new draft guidance document, published by the UK’s National Institute for Health and Care Excellence (NICE), warns physicians to take antimicrobial resistance (AMR) into account when prescribing antibiotics for COPD. 12 July 2018
Switzerland’s Roche and Chicago, USA-based AbbVie have submitted to extend the US label for Venclexta (venetoclax) as a first-line acute myeloid leukaemia (AML) therapy. 12 July 2018
With antimicrobial resistance (AMR) on the rise and health authorities and foundations around the world crying out for new antibiotics, Novartis has become the latest big pharma company to exit the space. 12 July 2018
Germany’s Merck KGaA has signed an agreement with Xian Janssen Pharmaceuticals to launch Invokana (canagliflozin), an innovative drug for adults with type 2 diabetes, in China. 12 July 2018
DUSA Pharmaceuticals has filed trade secret misappropriation and tortious interference claims in an ongoing patent infringement lawsuit against Germany-based skin cancer specialist Biofrontera and subsidiaries in the US District Court for the District of Massachusetts. 12 July 2018
At the annual meeting of 340B Health, a trade body representing hospitals participating in the 340B scheme, Health Secretary Alex Azar promised greater oversight in an effort to reign in costs. 11 July 2018
Takeda announced on Wednesday that Ninlaro (ixazomib) achieved its primary endpoint in the Phase III TOURMALINE-MM3 trial oriented toward multiple myeloma treatment. 11 July 2018
Having come under direct castigation from the US president, pharma giant Pfizer said yesterday that it will pull back on planned drug prices increases. 11 July 2018
With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 11 July 2018
The European Medicines Agency (EMA) has warned that a failure to prepare for Britain leaving the European Union could lead to major supply chain disruption for around 100 medicines. 11 July 2018
As a movie on anti cancer medication smuggled from India rakes in big bucks across China, the two countries have reached an agreement and have initiated specific measures for the import of Indian pharmaceuticals, especially anti-cancer drugs, reports The Pharma Letter’s India correspondent. 11 July 2018