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 subsidiary of family-owned Italian drugmaker Chiesi Farmaceutici today announced the launch of Bronchitol (mannitol) inhalation powder, an add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older. 17 March 2021
Japanese drug major Eisai today announced a research collaboration with Germany’s Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) aiming to create potential novel treatments for neurodegenerative disorders including Alzheimer’s disease (AD) which modulate immune competence in neurons and glia cells. 17 March 2021
The US Federal Trade Commission (FTC) and its counterpart competition enforcement agencies in the USA, European Union, the UK and Canada, are launching a working group to update their approach to analyzing the effects of pharmaceutical mergers. 17 March 2021
German pharma and life sciences major Merck today announced disappointing top-line data from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant of first-line platinum-based chemotherapy. 16 March 2021
A novel treatment for the viral disease CMV viremia, TAK-620 (maribavir), has generated positive results in the Phase III SOLSTICE trial. 16 March 2021
Basel’s Roche has announced new exploratory two-year data from the SUNFISH study of Evrysdi (risdiplam) in spinal muscular atrophy (SMA). 16 March 2021
A new strategy for the development of the domestic pharmaceutical sector until 2030 may soon be approved by the Russian government, according to recent statements some senior state officials and local media, reports The Pharma Letter’s local correspondent. 16 March 2021
Since the start of the fight against the COVID-19 pandemic, the Russian Direct Investment Fund has been in favor of active coordination with all partners, including from Europe, and open to negotiations, said the organization’s chief executive Kirill Dmitriev today. 15 March 2021
Stockholm’s Calliditas Therapeutics has completed its US regulatory submission for Nefecon (budesonide), an oral treatment for primary IgA Nephropathy (IgAN). 15 March 2021
Catherine Penny, partner, and Laura Beagrie, professional support lawyer, Stevens & Bolton, consider an important issue brought to light by the scramble for coronavirus vaccines. 12 March 2021
The Asia-Pacific (APAC) pharmaceutical strategic partnership landscape in 2020 was dominated by high-value deals, with Chinese oncology a particularly lucrative space, according to research from GlobalData. 12 March 2021
Japan’s largest drugmaker Takeda Pharma has outlined its ambition for above- market, double-digit revenue growth of its Growth and Emerging Markets Business Unit (GEM BU). 12 March 2021
As part of the USA’s $1.9 trillion American Rescue Plan Act that cleared its final congressional hurdle Wednesday, and President Joe Biden signed off on Thursday, $3.5 billion is earmarked for the Global Fund to Fight AIDS, Tuberculosis and Malaria. 12 March 2021
German company Bayer is confident that it can bounce back from a decline in the Pharmaceuticals division’s sales in 2024 due to the patent expirations for established blockbusters Xarelto (rivaroxaban) and Eylea (aflibercept). 11 March 2021
Cloud revenue management solutions provider Model N has announced findings from its 2021 State of Revenue Report, which examines current issues around revenue execution and management in the healthcare sector. 11 March 2021
For over two decades, the US Food and Drug Administration (FDA) has encouraged the incorporation of patient perspectives into drug development. A major component of the patient perspective is a drug’s effect on Quality of Life (QoL) – a concept that has always been a heterogeneous entity that lacks clear definition. 10 March 2021
The US Government Accountability Office (GAO) has called on the US Food and Drug Administration (FDA) to address a backlog in inspections that has been worsened by the pandemic. 10 March 2021
The hepatitis C virus (HCV) therapeutics market in Japan is highly competitive with stiff competition between USA-based drugmakers Gilead Sciences and AbbVie. 10 March 2021
A new long-acting HIV treatment under development by Gilead Sciences has produced positive results through 26 weeks in the Phase II/III CAPELLA trial. 10 March 2021