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 Joint Committee on Vaccination and Immunization (JCVI) has issued advice to the UK government on the use of the coronavirus (COVID-19) Oxford/AstraZeneca (LSE: AZN) vaccine for people aged under 40. 7 May 2021
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. 7 May 2021
Shares of Italian drugmaker Recordati fell 2.5% to 44.70 euros, after the company posted financial results for the first quarter of 2021 today. 6 May 2021
To the surprise of many, the US government has backed a World Trade Organization (WTO) proposal to disclaim certain intellectual property (IP) rights to coronavirus vaccines, after previously opposing it. 6 May 2021
The Russian drugmaker Nanolek plans to invest more than 5 billion roubles ($66 million) in the production of vaccines at its facilities within the next three years, according to recent statements by company and some local media, reports The Pharma Letter’s local correspondent. 5 May 2021
Takeda Pharmaceutical has officially launched full-cycle production of its Ninlaro (ixazomib) – a drug for the treatment of multiple myeloma - at its Russian plant in the Yaroslavl region, according to the company. 5 May 2021
Sales of Comirnaty, Pfizer’s BioNTech-partnered coronavirus vaccine, led the firm to a better-than-expected first quarter, with revenues up 45% at $14.6 billion. 4 May 2021
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, announced that the US Food and Drug Administration has approved Ferriprox (deferiprone) for the treatment of patients with transfusional iron overload due to sickle cell disease (or other anemias) in adults and children (age three and older). 4 May 2021
Even as the USA has rolled out a series of supportive measures to help India's fight against the COVID-19 upsurge, White House chief medical adviser and America's top pandemic expert Dr Anthony Fauci said Covaxin, India’s home-grown COVID-19 vaccine, has been found to neutralize the ‘617’ variant of the deadly virus, reports The Pharma Letter’s India correspondent. 4 May 2021
The US Food and Drug Administration on Friday approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. 1 May 2021
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has filed its response to the European Union (EU) roadmap/IIA on the Evaluation and revision of the general pharmaceutical legislation. 30 April 2021
Rare forms of multiple sclerosis (MS) exhibit certain atypical imaging characteristics that are absent in typical MS, although the clinical features of these variants are similar to typical MS. 30 April 2021
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged two years and over with diabetes mellitus, said the drug’s developer, Xeris Pharmaceuticals. 30 April 2021
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a Phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro (PA21: sucroferric oxyhydroxide) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment. 30 April 2021
US pharma major Merck & Co became the latest drugmaker to announce disappointing, pandemic-hit first quarter 2021 financial results, sending shares in the company down by 3% in Thursday’s early trading. 29 April 2021
Global spending on medicines - using invoice price levels - is expected to grow at a 3%-6% compound annual growth rate (CAGR) through 2025 to reach a value of about $1.6 trillion by 2025, excluding spending of COVID-19 vaccines, according to a new research report. 29 April 2021
A Special Report on the top five trends redefining the way healthcare stakeholders look at long-term healthcare access sustainability in the region from Roshel Jayasundera, director, Global Consulting, Axios International. 28 April 2021