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 Novartis unit Sandoz has signed an agreement with Japanese drugmaker Shionogi for the commercialization of Rizmoic (naldemedine) in Europe. 11 April 2019
Regulators have a role to play in ensuring that there is a solid evidence base to support the assessment of added therapeutic benefit of novel treatments compared with existing and potentially cheaper therapies. 11 April 2019
Just as the next-generation Respimat inhaler hits the first European markets, Boehringer Ingelheim has completed the investment of 105 million euros ($118 million) to expand associated production operations at its sites in Dortmund and Ingelheim. 11 April 2019
The UK’s health technology assessor is leaning against reimbursing Novartis’ breast cancer drug Kisqali (ribociclib), plus Faslodex (fulvestrant), for treating certain people with breast cancer. 10 April 2019
The European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. 10 April 2019
Ned Sharpless, the man tasked with filling the shoes left by the departed US Food and Administration (FDA) Commissioner Scott Gottlieb, is just getting his feet under the desk. 10 April 2019
The Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the clinical effectiveness and value of two new technologies to induce immune tolerance — Viaskin Peanut, and AR101 — as well as non-commercialized oral immunotherapy (OIT). 10 April 2019
A US federal grand jury indicted Indivior on Tuesday on charges the company orchestrated a “nationwide scheme,” with the news sending the shares plunging this morning. 10 April 2019
Privately-held Danish medical dermatology specialist LEO Pharma has inked a new deal with US-based Elektrofi, a drug formulation and delivery firm. 10 April 2019
Phase IIIb clinical trial results from the ALPINE study, evaluating Ireland-incorporated Alkermes’ Aristada (aripiprazole lauroxil) and Johnson & Johnson subsidiary Janssen Pharmaceuticals' Invega Sustenna (paliperidone palmitate) in 200 patients experiencing acute exacerbations of schizophrenia showed comparable efficacy with similar safety profiles. 9 April 2019
Daiichi Sankyo says that valemetostat (DS-3201), an investigational and potential first-in-class EZH1/2 dual inhibitor, has received Sakigake designation from the MHLW. 9 April 2019
Zogenix has disclosed that the US Food and Drug Administration has issued a Refusal to File (RTF) letter regarding its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. 9 April 2019
Pharma needs to pay closer attention to ensuring the integrity of its third-party relationships, writes Kathy Johnson, vice president life sciences, LexisNexis Risk Solutions Health Care, in an Expert View piece. 9 April 2019
The US Food and Drug Administration on Monday approved the investigational two-drug single-tablet regimen (STR) Dovato (dolutegravir/lamivudine) for the treatment for HIV-1 infection in adults who have not previously been treated with antiretroviral drugs. 9 April 2019
The Russian Parliament has announced plans to limit the maximum share of pharmaceutical distributors and pharmacies in the domestic market and to oblige the latter to allocate up to 50% of their sale ranges for domestic drugs. 8 April 2019
The president of Greek industry association the Hellenic Association of Pharmaceutical Companies (SFEE), painted an alarming picture on the current and future state of Greek healthcare at the group’s general assembly meeting. 8 April 2019