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
Merck has revealed positive data from the Phase III KEYNOTE-426 trial of Keytruda (pembrolizumab) plus Inlyta (axitinib) in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC). 19 October 2018
The US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of prucalopride (SHP555) supports the approval of this New Drug Application (NDA). 19 October 2018
Something like 20,000 conference delegates are gathered in Munich for the start of what promises to be another important meeting of the European Society of Medical Oncology. 19 October 2018
A new report from industry analyst the IQVIA Institute finds that, with a record-breaking number of new approvals, orphan drugs accounted for 9.6% of total sales in the USA last year. 18 October 2018
AbbVie today announced that it has entered into a research and development collaboration designed to advance a number of Morphic Therapeutic's oral integrin therapeutics for fibrosis-related indications. 18 October 2018
Swiss giant Novartis has released an upbeat financial results statement for the third quarter of 2018, with a 3% rise in revenues to $12.8 billion, roughly in line with analysts’ expectations. 18 October 2018
Swiss pharma giant Novartis today announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. 18 October 2018
When the European Commission published its report on the State of Health in the European Union last year, it recognized five ongoing trends in health system reform: shifting to prevention, stronger primary care, integration of care, supporting a resilient health workforce and developing better patient-centered data. 18 October 2018
The market for targeted therapies in hepatocellular carcinoma (HCC) is still sparse and homogeneous in terms of MOAs and combinations, providing an opportunity for pharma and biotech developers to capture some of this market with diverse novel agents. 17 October 2018
Japan’s Eisai and partner Purdue Pharma today released positive top-line results from SUNRISE 2, a long-term Phase III efficacy and safety evaluation of lemborexant, an investigational agent for sleep-wake regulation currently being studied for the potential treatment of multiple sleep-wake disorders. 17 October 2018
Sumitomo Dainippon Pharma has announced a 700 million yen ($6 million) investment in a company that aims to enhance the functionality of cyborg technologies and the combination of bio-signal processing and robotics. 17 October 2018
Diurnal has provided an update on its Alkindi (hydrocortisone) and Chronocort (hydrocortisone) program, stating that a further analysis of data shows a more promising result than it had first thought. 17 October 2018
Roche today released sales figures for the first nine months of 2018, showing that group sales increased 7% at constant exchange rates and in Swiss francs to 40.08 billion francs $40.48). The company does not reveal any profit figures at the quarterly stage. 17 October 2018
Among the millions of perspectives for UK Prime Minister Theresa May to consider during Wednesday’s talks with European Union (EU) leaders over a Brexit deal is that of AstraZeneca, one of the largest UK drugmakers. 17 October 2018
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). 17 October 2018
In terms of revenue, the global pneumococcal vaccines market is projected to register a compound annual growth rate (CAGR) of 9.1% over the 2018-2028 forecast period. 16 October 2018
Shares in Johnson & Johnson rose 2% within an hour's trading on Tuesday after the US healthcare giant presented its third-quarter financial results, which saw the Janssen pharma unit post particularly impressive sales figures. 16 October 2018
The White House has signalled its intention to press ahead with proposals to force drugmakers to include drug pricing information in direct-to-consumer advertising, despite the apparent inability of Congress to sign up to the idea. 16 October 2018
Japanese pharma major Eisai has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride in 17 countries in Latin America and the Caribbean, excluding Brazil, to Eurofarma Laboratórios, which has a business foundation in Latin America. 16 October 2018
After what chief executive Stefan Oschmann said had been a “challenging year” for Germany’s Merck KGaA, the company is targeting a return to profitable growth in 2019. 16 October 2018