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 European Medicines Agency today released highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that was held November 27-30, 2017. 1 December 2017
Speaking before a congressional committee in the US House of Representatives, FDA Commissioner Scott Gottlieb confirmed Thursday that his agency is honing in on new ways to approve certain drugs faster. 1 December 2017
A leading trade group for pharmacy benefit managers (PBM) has issued a highly critical response to a recent report from the pharmaceutical industry blaming PBMs for high drug prices in the USA. 1 December 2017
The US Food and Drug Administration has approved Sublocade (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD). 1 December 2017
Following the formation of a dedicated strategic business unit oncology earlier this year within its pharmaceuticals division, Germany’s Bayer announced today it will further strengthen its strategic pharmaceutical research and development activities and bring them together under one leadership. 1 December 2017
The US Department of Veterans Affairs (VA) has placed the first new Food and Drug Administration-approved treatment option for amyotrophic lateral sclerosis (ALS) in more than 20 years on its National Formulary for coverage. 30 November 2017
The Russian government has surprisingly decided to make concessions to domestic and global drugmakers operating in the country through the extension of the time, required for the mandatory labeling of drugs, reports The Pharma Letter’s local correspondent. 30 November 2017
The 25 recommendations released in the Australian Senate Select Committee report reveal the challenges the country faces to ensure that all Australians get access to the treatments and medicines they need when they need them, regardless of the type of disease. 30 November 2017
American lawmakers meeting in a closed-door session reportedly received assurances from President Trump that he would be willing to support measures that would bolster the wobbling Obamacare exchange markets, in return for an end to the individual mandate. 29 November 2017
US drugmaker Melinta Therapeutics and The Medicines Company have entered into an agreement whereby Melinta will acquire the infectious disease business from The Medicines Company (TMC). 29 November 2017
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today announced Viagra Connect (containing sildenafil 5mg) will be formally classified from a prescription-only medicine (POM) to a pharmacy medicine (P). 29 November 2017
Denmark-based allergy specialist ALK-Abelló today announced that Helle Skov, executive vice president of product supply and a member of ALK's board of management, leaves the company by mutual agreement. 29 November 2017
Multiple trade groups representing the pharmaceuticals industry in Europe have issued a joint statement calling on the UK and EU to agree to a Brexit transition period. 28 November 2017
The UK managing directors (MDs) of three US pharma majors have given a House of Lords Committee their views on how to make the UK more competitive in attracting investment in the life sciences. 28 November 2017
Israeli ophthalmics specialist BioLight has announced that it has agreed to sell IOPtima, a developer of minimally-invasive surgical ophthalmic devices specializing in glaucoma, in which the firm has a majority stake. 28 November 2017
GlaxoSmithKline has submitted a New Drug Application to the US Food and Drug Administration, seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. 28 November 2017
An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from the World Health Organization (WHO). 28 November 2017
Ardelyx has entered into a license agreement that provides Japan’s Kyowa Hakko Kirin with exclusive rights to develop and commercialize Ardelyx's lead investigational product, tenapanor, for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan. 28 November 2017