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
When the US Food and Drug Administration found that it was in danger of drowning in the volume of safety reports being submitted relating to approved therapies, the agency brought in Transcelerate BioPharma to help. 17 October 2019
A new report from industry analyst GlobalData highlights the low rate of diagnosis and treatment for osteoporosis, resulting in a high burden on both patients and society. 17 October 2019
Dutch specialty pharma company Pharming Group has been named in an injunction secured in the USA by CSL Behring over the alleged stealing of proprietary information. 17 October 2019
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee yesterday voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options. 17 October 2019
Texan ocular health firm Eyevance Pharmaceuticals has acquired two more products, the latest move in an aggressive growth strategy for the two year-old privately-held company. 17 October 2019
USA-based Mycovia Pharmaceuticals has entered into an exclusive license and development and technology transfer agreement with Hungary's largest drugmaker Gedeon Richter to commercialize and manufacture VT-1161 (otesaconazole) in Europe, Latin America, Australia, Russia and other CIS countries. 17 October 2019
Alexion Pharmaceuticals is buying Factor D inhibitor specialist Achillion Pharmaceuticals in a deal worth around $930 million, or $6.30 per share. 16 October 2019
Shares in US healthcare giant were up 2% after 90 minutes of trading on Tuesday after the group presented its third-quarter financial results. 15 October 2019
The first drug pricing report, mandated under California’s new price transparency law, has been released by the Office of Statewide Health Planning and Development (OSHPD). 15 October 2019
Japan’s largest drugmaker Takeda has agreed to sell a portfolio of around 30 select prescription pharmaceutical and over-the-counter (OTC) products sold in the NEMEA region to Acino. 15 October 2019
US drugmaker Abbott has expanded production at its Russian plant in the Vladimir region, according to recent statements by the company. 15 October 2019
The Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding, says Johnson & Johnson. 14 October 2019
The Irish Pharmaceutical Healthcare Association (IPHA) says that the country’s government must make sure that Brexit does not cause access to medicines to fall further relative to other European countries. 14 October 2019
M&A activity in the biopharma sector was relatively low from early 2010 through 2014 (purchased market cap each year below 0.6% of sector market cap), according to a new evaluation by SVB Leerink Research analyst Geoffrey Porges. 14 October 2019
For more than a decade, the main area of interest and focus in oncology has been the astonishing progress of immuno-oncology therapies, led lately by the all-conquering Keytruda (pembrolizumab). 14 October 2019
The European subsidiary of Japan’s Daiichi Sankyo (TYO: 4568) today announced one-year follow-up results from an analysis of 12,574 European non-valvular atrial fibrillation (NVAF) patients, mostly elderly, treated with its already-marketed Lixiana (edoxaban). 14 October 2019
India's largest drugmaker, Sun Pharmaceutical, today said that one of its wholly-owned subsidiaries has commercialized Cequa (cyclosporine ophthalmic solution) 0.09% in the USA. 14 October 2019
US-based digital health company VirTrial has launched an alliance with Pratia, the largest network of clinical research centers in Europe, to bring its virtual trial technology across the Atlantic. 14 October 2019