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
Athenex closed down 54.9% at $5.46 on Monday after it revealed that the US Food and Drug Administration had issued a complete response letter (CRL) relating to the company’s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. 2 March 2021
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the opportunity to participate in the European Commission’s structured dialogue on supply chain security. 1 March 2021
A promising treatment for a cancer-causing rare disease will be the first to pass a significant milestone under a new UK approval process designed to bring medicines more rapidly to patients. 1 March 2021
Brazil’s Ministry of Health (MoH) and Fiocruz last week launched a public notice for the construction of the Industrial Complex of Biotechnology in Health (Cibs, in the Portuguese acronym). 1 March 2021
The US Food and Drug Administration on Friday approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to molybdenum cofactor deficiency Type A, a rare, genetic, metabolic disorder that typically presents in the first few days of life, causing intractable seizures, brain injury and death. 1 March 2021
Not surprisingly, given rather positive briefing documents from US Food and Drug Administration staffers earlier this week, the agency’s Vaccines and Related Biological Products Advisory Committee gave the thumbs up for COVID-19 vaccine Janssen to be approved for emergency use authorization (EUA) following deliberations on Friday. 27 February 2021
“Companies are borderless,” said Mark Duxon, chief executive of Transpharmation, a contract research organization (CRO) that has now added a Polish site to its UK and Irish facilities. 26 February 2021
At its February meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)recommended extensions of indication for: 26 February 2021
Agreement has been reached for Takeda to transfer the assets, marketing rights and, eventually, marketing authorization associated with a portfolio of diabetes products in Japan to fellow Japanese firm Teijin Pharma. 26 February 2021
In the UK, a tribunal has upheld a finding from the country’s antitrust regulator, the Competition and Markets Authority (CMA), which found that the wholesaler Lexon broke competition law. 25 February 2021
Daiichi Sankyo has signed collaborations with European research groups to study the company’s valemetostat (DS-3201), a potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a Phase II study in patients with five subtypes of relapsed/refractory B-cell lymphoma. 25 February 2021
Werner Baumann, chairman of the board of management of German life sciences company Bayer, said that the firm had shown resilience during the group’s presentation of its annual and fourth-quarter 2020 financial results, but investors appear unconvinced. 25 February 2021
The US Food and Drug Administration (FDA) looks closer to granting Emergency Use Authorization (EUA) for the single-dose Janssen COVID-19 vaccine candidate. 25 February 2021
Danish diabetes care giant Novo Nordisk today announced plans to invest 500 million Danish kroner ($81.6 million) in expanding facilities at its production site in Måløv, Denmark. 25 February 2021
In recent weeks there has been much criticism around the availability of COVID-19 vaccine supplies to less developed countries, with various consumer groups and some European governments calling for countries to ignore patent protection to allow local drugmakers to manufacture the vaccines, and accusing the western world of hording. 24 February 2021
In an attempt to change India’s image as a manufacturer and exporter of low-value drugs, the government on Wednesday announced yet another $2.07 billion production-linked incentive (PLI) scheme for promoting manufacture of high-value products in the pharmaceutical sector. 24 February 2021
The market performance of the top 20 Bio/Pharma companies is still being impacted by the COVID-19 pandemic, either positively for companies developing a vaccine for the disease or negatively for those working on a treatment. 24 February 2021