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 safety of titanium dioxide as a food additive has been thrown into doubt, which itself has raised questions for drugmakers, reports PharmaLex's Thomas Eberwein. 12 August 2021
India’s Zydus Cadila, which has developed what will be India's second home-made vaccine against the coronavirus disease, has developed a live, attenuated recombinant measles virus-vectored vaccine, ZyCoV-MV, which is believed to provide long-term immunity from the infection. 12 August 2021
Central nervous system (CNS) specialist Axsome Therapeutics will hope a positive report from GlobalData could take the sting out of a recent run of bad news. 12 August 2021
Specialty UK pharma company Shield Therapeutics has entered into an exclusive licence agreement for Accrufer/Feraccru (ferric maltol) with Korea Pharma in the South Korea. 12 August 2021
Japanese drugmaker Chugai says it has launched Evrysdi (risdiplam) Dry Syrup 60mg for the treatment of spinal muscular atrophy (SMA). Evrysdi had been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) on June 23, 2021, and was listed on the national health insurance (NIH) reimbursement price list this week. 12 August 2021
The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients. 12 August 2021
Eli Lilly has won a positive reimbursement decision in the UK for Verzenios (abemaciclib) as an option for people with advanced HR+ HER2-breast cancer. 12 August 2021
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. 11 August 2021
Australia’s Therapeutic Goods Administration (TGA) granted provisional determination for Merck & Co’s molnupiravir, which will be processed by the US pharma major’s Merck Sharp & Dohme (Australia) Pty Ltd (MSD) unit. 11 August 2021
Japan’s Otsuka Pharmaceuticals has been handed a grant for up to $17.8 million from the Bill & Melinda Gates Foundation to support the clinical trial of a treatment-shortening regimen in drug-sensitive tuberculosis (TB). 11 August 2021
In the latest twist in the battle to acquire Vectura, the board of the UK inhaled therapies maker today acknowledged that Carlyle, one of the two bidders, has announced it will not improve its 155 pence per share offer for the company, as declared on August 6, through its Murano Bidco vehicle. 11 August 2021
Raman Sehgal, the founder of ramarketing, provides an Expert View on how pharmaceutical and life sciences businesses can market themselves in the post-pandemic environment. 10 August 2021
The Russian government is considering a further tightening of public procurements of drugs for state needs by introducing the “second extra” principle, when the application of a Russian company that failed to localize the production of raw materials within the country will be rejected, according to recent statements made by some senior state officials and some local media reports. 10 August 2021
A self-styled pioneer that promises to develop and deliver innovative medicines to patients at radically lower prices, is to raise up to $1.8 billion via a combination with special purpose acquisition company (SPAC) CM Life Sciences III, as it looks to accelerate its growth. 9 August 2021
The Indian subsidiary of Anglo-Swedish pharma major AstraZeneca has reported a 45.03% decline in its net profit to $1.37 million for the June ended fiscal quarter. 9 August 2021
Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). 9 August 2021
Following the announcement on Friday that the board of Vectura had accepted an improved takeover offer from private equity group Carlyle of 155 pence a share, Philip Morris has increased its previous offer for the UK inhaled medicines company. 9 August 2021
Through the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz), Brazil’s Fiocruz has reached 80.4 million doses of the COVID-19 vaccine made available to the National Immunization Program (PNI), delivering around 2.2 million doses on July 30. 9 August 2021