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
Under pressure from the US Food and Drug Administration, Ireland-incorporated Endo International has agreed to voluntarily withdraw its opioid pain drug Opana ER (oxymorphone hydrochloride extended release) from the US market. 7 July 2017
Following a review of health data from 77 countries, the World Health Organization has issued a warning about the rise of antibiotic-resistant strains of gonorrhea. 7 July 2017
A conference on the role of the Russian professional medical community in healthcare development, which was dedicated to the 10th anniversary of the Association of Clinical Pharmacologists of St Petersburg, took place earlier this week. 7 July 2017
Eli Lilly announced in March that it would invest $850 million in US operations this year, and a new collaboration suggests a desire to fund research not just in the USA, but in the company’s home state. 6 July 2017
UK drugmaker GlaxoSmithKline will be hoping for a stabilization in its share price on Thursday afternoon after a significant slide was started by a broker downgrading its stock recommendation. 6 July 2017
American diabetes startup Diasome Pharmaceuticals has received up to $30 million in funding from a group of four investors, led by British life science venture capitalists Medicxi. 6 July 2017
The European Commission has sent three separate Statements of Objections to Germany’s Merck KGaA and its subsidiary Sigma-Aldrich, General Electric and Canon alleging they breached EU merger rules. 6 July 2017
National Health Service trusts in England reported a £791 million ($1 billion) deficit last year, despite receiving an additional £1.8 billion from government through a reform program. 5 July 2017
Members of the European Parliament (MEPs) today urged the Commission to address the increase in HIV/AIDS, tuberculosis and viral hepatitis cases in the EU and to develop long-term programs. 5 July 2017
Italian drugmaker Recordati has announced the US launch of a 350mg single-vial dosage strength of Panhematin (hemin for injection) for the amelioration of recurrent attacks of acute intermittent porphyria (AIP). 5 July 2017
The National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending asfotase alpha for people with pediatric-onset hypophosphatasia – a very rare inherited condition affecting between one and seven babies each year in England. 5 July 2017
The growing number of clinical trials and increasing complexity across the clinical lifecycle are putting pressure on life sciences organizations to improve study quality and execution, writes Rik Van Mol, vice president of R&D strategy, Europe, Veeva Systems, in an Expert View piece. 4 July 2017
Dr Nicola Davies looks at how real world evidence carries ever greater importance in an industry where often regulatory approval alone is no longer enough. 4 July 2017
After a year of uncertainty, a letter written by two senior government ministers has finally sought to clear up what the UK’s relationship with the European Medicines Agency (EMA) might look like after Brexit. 4 July 2017
The European Commission has published a new action plan which reviews the global problem of antimicrobial resistance and sets out guidance for EU bodies to combat the issue. 4 July 2017
An approach that aims to facilitate development of rare pediatric diseases in general, and as a starting point Gaucher disease in particular, has been outlined by regulatory bodies in the European Union and the USA. 4 July 2017
The restoration of key occupations for the medical technology, biotechnology, research and pharmaceutical sector to the skilled migration visa list has been welcomed by six representative organizations in Australia. 4 July 2017
The purchase of major pharma contract research organization Parexel was the largest deal of the month as it was taken private by Pamplona Capital Management. 3 July 2017
Obstacles standing in the way of successful launches of Russian products to international pharma markets have been highlighted by trade group the Association of Russian Pharmaceutical Manufactures (ARPM) following industry meetings. 3 July 2017
Marking its second major regulatory approval, Eli Lilly and Incyte Corp today revealed that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Olumiant (baricitinib) tablets for the treatment of rheumatoid arthritis. 3 July 2017