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
Congenital adrenal hyperplasia (CAH) refers to a group of rare, genetic disorders that affect the functioning of the adrenal glands. For CAH Awareness Month, Dr Nicola Davies explores the current treatment options for CAH and any treatments on the horizon. 3 July 2020
The European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, US biotech Gilead Sciences announced, 3 July 2020
The European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include renal outcome data from the CREDENCE trial. 3 July 2020
Weeks after receiving US approval for its fourth-line gastrointestinal stromal tumor (GIST) option, Deciphera Pharmaceuticals has presented new data supporting use of the therapy. 3 July 2020
Shares in San Diego-based MEI Pharma fell by nearly a fifth on Thursday, following news that a Phase III study of pracinostat in acute myeloid leukemia (AML) had failed. 3 July 2020
An Expert View from Jonathan Roses, counsel, Wolf, Greenfield & Sacks, and Toby Simpson, partner, Hoffmann Eitle, exploring legal differences between the two major jurisdictions of the USA and Europe that life sciences companies should be aware of. 3 July 2020
The US Food and Drug Administration has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, marking the second approval for UK-based Acacia Pharma. 3 July 2020
US health technology assessor the Institute for Clinical and Economic Review (ICER) has published a white paper to inform public and policy maker discussion of “Alternative Policies for Pricing Novel Vaccines and Drug Therapies for COVID-19.” 3 July 2020
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published Novel Pricing and Payment Models: New solutions to improve patient access. 3 July 2020
Following in the footsteps of AstraZeneca and others, Boehringer Ingelheim has become the latest big pharma company to make a major investment in accessing external innovation in China. 2 July 2020
As drug and vaccine developers are scrambling to scale up production and marketing of potential COVID-19 therapies, a unit of Japan’s Fujifilm Corp has signed a major collaboration on the development, manufacture and sales of its anti-influenza virus drug Avigan (favipiravir). 2 July 2020
Swiss pharma giant Novartis has finalized its $678 million settlement relating to a lawsuit alleging impropriety in its speaker programs and other promotional events conducted from 2002 through 2011 in the USA. 2 July 2020
The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and affiliate ChemRar Group produced the first 100,000 courses of the Russian coronavirus drug Avifavir (favipiravir) in June, significantly exceeding initially planned production levels of 60,000 courses, the partners announced. 2 July 2020
In the context of widespread lockdowns linked to the coronavirus pandemic, Swedish digital therapy specialist Orexo DTx sees an increasingly significant treatment opportunity for two newly-launched products. 2 July 2020
Ireland-incorporated Avadel Pharmaceuticals has sold its hospital sterile injectable drug portfolio to Exela Sterile Medicines for a total of $42.0 million. 2 July 2020
On Monday, the European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson (NYSE: NJ) company, for a vaccine against Ebola. 2 July 2020
The US Food and Drug Administration (FDA) has delivered a clear message alongside its provision of guidance for those developing COVID-19 vaccines for the ultimate purpose of licensure. 1 July 2020
Shaun Thaxter, the chief executive of Indivior, has pleaded guilty to causing the introduction into interstate commerce of the opioid drug Suboxone Film (buprenorphine) which was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. 1 July 2020
Privately-held Danish medical dermatology specialist LEO Pharma today announced that Dr Monica Shaw and Nathalie Joannes will join the executive leadership team adding seasoned experience and international profile to the company. 1 July 2020
A TLR-4 antagonist has been selected as the first investigational immune modulation therapy to be included in the “moderate” arm of an adaptive trial testing therapies against COVID-19. 1 July 2020