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
With so much focus on products to fight the COVID-19 pandemic, French pharma major Sanofi has made clear it is not neglecting regular seasonal flu. 1 April 2021
Dutch specialist development pharma, Amzell has signed a license and development agreement with Amring Pharmaceuticals, a subsidiary of SEVER Life, for the commercial rights to one of its leading clinical-stage candidates. 31 March 2021
The European cannabis market is forecast to grow with a compound annual growth rate (CAGR) of 67.4% to reach 3.2 billion euros ($3.75 billion) by 2025, a new report has found. 31 March 2021
Daiichi Sankyo today said that it will terminate its 2015 marketing alliance agreement for the Squarekids subcutaneous injection syringe, a tetravalent combination vaccine1 and its joint development agreement on pentavalent combination vaccine2 (VN-0105) with the local subsidiary of French pharma major Sanofi, effective March 31, 2021. 31 March 2021
The NDA Group, a regulatory, drug development and medical device consultancy, has released findings from the eighth annual comparison of drug approvals in the European Union (EU) and the USA. 31 March 2021
The European Commission has granted conditional marketing authorization for Nexpovio (selinexor), a first-in-class, oral selective inhibitor of nuclear Export (SINE) medicine, in combination with dexamethasone. 31 March 2021
Shares of Australia oncology-focused drug developer Kazia Therapeutics closed up 10% at A$1.59 today, and rose as much as 20% pre-market, after it announced a licensing deal for its lead candidate paxalisib. 30 March 2021
A statement from the European pharma industry criticizes progress on a new proposal for making health technology assessments more efficient in the region. 29 March 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended five novel medicines for approval at its March 2021 meeting. A final decision on the approval by the European Commission is usually issues in about two-three months. 27 March 2021
Following its March meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced recommendations for the extension of indications on six already approved drugs. 27 March 2021
Japan’s leading drugmaker Takeda says that the European Medicines Agency (EMA) has accepted the company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. 26 March 2021
A new US indication has been approved for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. 26 March 2021
Medicines to treat infectious diseases and inflammatory disorder, as well as cancers, Alzheimer’s and rare diseases that collectively affect millions of people are under development by pharma and biotech, but the problem now is to deliver them to patients. 26 March 2021
Dutch specialist pharmaceutical development company Amzell has acquired Bazell Pharma, a high-end clinical development and R&D laboratory facility based in Allschwil, Switzerland, to help to accelerate its development pipeline of late-stage novel drug candidates. 25 March 2021
The Association of the British Pharmaceutical Industry (ABPI) wants the UK government to make improving cancer outcomes a priority funding focus. 25 March 2021
Japanese firms Ono Pharmaceutical and Seikagaku Corp have announced that Seikagaku has obtained manufacturing and marketing approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) for Joyclu (diclofenac etalhyaluronate sodium; ONO-5704/SI-613) 30mg Intra-articular Injection for the indication of osteoarthritis (knee joint and hip joint). 25 March 2021
GlaxoSmithKline, the majority shareholder of Galvani Bioelectronic, today announced the termination of Moncef Slaoui as chairman of the Galvani board of directors, effective immediately. 24 March 2021
2020 was a good year for Boehringer Ingelheim, although the effects of the COVID-19 pandemic were omnipresent, said the German family-owned pharma major. 24 March 2021
New results from the STEP Phase IIIa clinical trial program demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4mg versus placebo. 24 March 2021