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 has informed Ireland-incorporated specialty pharma firm Mallinckrodt that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational allogeneic cellularized scaffold product 19 February 2021
Moscow’s Sistema, an investment company, has launched a new pharmaceutical holding company, Binnopharm Group, together with the Russian Direct Investment Fund (RDIF). 19 February 2021
Portugal’s largest drugmaker BIAL has announced that, from today, the company will take the lead for commercialization of their epilepsy treatment Zebinix (eslicarbazepine acetate) in Europe, thus ending the license agreement signed in 2009 with Japan’s Eisai . 18 February 2021
Ferring Pharmaceuticals and its Rebiotix subsidiary have announced a multi-year strategic collaboration with Israeli biopharma MyBiotics Pharma. 18 February 2021
To prepare Europe for an increased threat of coronavirus variants, the President of the European Commission, Ursula von der Leyen, has announced the start of European bio-defense preparedness plan called “HERA Incubator.” 18 February 2021
US drugmaker Eli Lilly has announced trial results on tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist molecule that represents a new class of medicines being studied for the treatment of type 2 diabetes. 17 February 2021
Through the Brexit deal struck between the UK and European Union (EU), the UK will be part of Horizon Europe, the EU’s next framework program for research and innovation. 17 February 2021
Japanese drugmaker Chugai Pharmaceutical announced today that it has refiled a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, regarding the generic drugs of an osteoporosis agent, active vitamin D3 derivative Edirol capsule 0.5 g / 0.75 g (eldecalcitol). 17 February 2021
The US Food and Drug Administration has approved the following expanded indication for Entresto (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. 17 February 2021
Spanish dermatology firm Almirall has inked a deal with Denmark’s MC2 Therapeutics, gaining exclusive European rights to commercialize Wynzora (calcipotriene/betamethasone dipropionate) in plaque psoriasis. 17 February 2021
The US regulator has issued a warning to AcelRx Pharmaceuticals over its marketing of opioid analgesic Dsuvia (sufentanil), causing shares in the company to fall 8%. 17 February 2021
German drugmaker Stada Arzneimittel is launching Lecigon (levodopa/carbidopa/entacapone), a triple combination product with modern pump technology, in Germany and Austria as the lead markets for the treatment for advanced Parkinson's disease. 15 February 2021
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), a statutory committee established under the National Health Act 1953, today announced changes to its listing recommendations process. 15 February 2021
The European Commission (EC) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. 15 February 2021
The use of digital health technologies has grown rapidly over the last couple of years – accelerating even more during the COVID-19 pandemic. As digital health continues to hold an important place in modern healthcare, it is critical to ensure the safety of digital health devices and applications. Regulation of these devices by the US Food and Drug Administration (FDA) is fundamental to achieving this goal. 15 February 2021
The Pharmacovigilance Risk Assessment Committee (PRAC), a unit of the European Medicines Agency, has concluded its review of a safety signal to assess reports of acute kidney injury (AKI) in patients with COVID-19 treated with Veklury (remdesivir). 12 February 2021
The New England Journal of Medicine (NEJM) has published the results from the pivotal Phase III trials of Klisyri (tirbanibulin) ointment for actinic keratosis; the two double-blind, vehicle-controlled, randomized, parallel-group, multicenter, trials (KX01-AK-003 and KX01-AK-004). 11 February 2021
The European Medicines Agency (EMA) has issued a statement clarifying that it has not received an application for a rolling review or a marketing authorization for Russia’s homegrown vaccine, Sputnik V. 11 February 2021