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 strictly prohibits the distribution of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, and expired drugs that pose a serious threat to life. Nevertheless, such drugs continue to end up in circulation, compromising patient safety. 24 May 2021
Eli Lilly’s tirzepatide has achieved all primary and key secondary study outcomes against insulin glargine in adults with type 2 diabetes and increased cardiovascular (CV) risk in the SURPASS-4 trial. 21 May 2021
Japan-based Sosei Group has been notified by US pharma giant Pfizer that the first subject in a clinical trial has been dosed with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies. 21 May 2021
Japanese pharma major Daiichi Sankyo received a major headway in the global oncology space with the launch of its first antibody drug conjugate (ADC) therapy Enhertu (trastuzumab deruxtecan). 21 May 2021
AJ Ploszay, vice president of digital strategy, IQVIA, provides an Expert View on how the precedent for consumer buying set by companies like Amazon, further accelerated by the digital buying trends driven by COVID-19, are influencing a similar shift in the commercial pharma space. 20 May 2021
A new rheumatoid arthritis (RA) drug, olokizumab, has been found to offer significant benefits to RA patients, following its completion of Phase III ‘CREDO’ trials. 20 May 2021
American and British healthcare industry professionals are positive the UK will remain an attractive destination for healthcare research post-Brexit, according to a GlobalData survey. 20 May 2021
Even as Asia attracted a significant amount of cross-border investment, accounting for more than half of global Foreign Direct Investment (FDI), FDI equity inflows into India increased by 13%, with the country receiving more than $30 billion in the first half of the financial year ending March 2021. With the Indian government seeking FDI specifically from companies intending to diversify manufacturing operations away from China, the $30 billion swell incorporates a tidy amount in the pharmaceutical sector, reports The Pharma Letter’s India correspondent. 19 May 2021
Medicago and UK-based drugmaker GlaxoSmithKline have reported positive interim Phase II trial safety and immunogenicity data for the Canadian company’s plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant. 18 May 2021
US pharma giant Merck & Co’s Russian MSD unit has revoked the registration certificate on its Belsomra (suvorexant) next-generation sleeping pill in Russia, due to the inability of the company to generate sales in the local market, reports The Pharma Letter’s local correspondent. 18 May 2021
The Hellenic Association of Pharmaceutical Companies (SFEE) participated for the 6th consecutive year, on May 10, 2021, in the Delphi Economic Forum, held under the auspices of the President of the Hellenic Republic, M Katerina Sakellaropoulou. 17 May 2021
At the annual meeting of the American College of Cardiology (ACC), poor results for Novartis’ Entresto (sacubitril/valsartan) have disappointed. 17 May 2021
Detailed results from the Phase III DARE-19 trial, testing AstraZeneca's (LSE: AZN) SGLT2 blocker Farxiga (dapagliflozin) in COVID-19, show no significant benefit for patients. 17 May 2021
Bristol Myers Squibb has announced a new analysis of data from the Phase III EXPLORER-HCM study of mavacamten, the firm’s investigational, first-in-class cardiac myosin inhibitor. 17 May 2021
The mere notion of the US government supporting any policies that might encourage pharmaceutical patents to be ignored would have seemed inconceivable only 18 months ago. 17 May 2021
German family-owned pharma major Boehringer Ingelheim has provided important new evidence about the longer-term use of Ofev (nintedanib), which was approved in the USA in September 2019 and in Europe in March 2020 for use in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a rare autoimmune disease. 14 May 2021
An Expert View from Manjit Singh, chairman of the Pharmaceutical Supply Chain Initiative, which tries to foster responsible supply chains, highlighting the issue of antibiotic resistance and the often-underestimated threat coming from the discharge of material in environment. 14 May 2021
Germany’s Boehringer Ingelheim today presented three new data analyses, which reinforce the importance of adhering to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations when prescribing treatments for people living with chronic obstructive pulmonary disease (COPD). 14 May 2021