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
In the UK, the medicines regulator has given a positive scientific opinion on Novartis’ investigational treatment asciminib, under the Early Access to Medicines Scheme (EAMS). 25 January 2022
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck & Co’s New Drug Application (NDA) for gefapixant, the orally administered selective P2X3 receptor antagonist, under development for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. 25 January 2022
Protas, a UK-based independent not-for-profit organization, designing and delivering large, global randomized clinical trials of treatments for common and other life-threatening diseases, launches today and announces French pharma major Sanofi as its first strategic partner. 25 January 2022
The year 2022 promises to continue the upward trajectory of development for orphan drugs. Financial projections from the previous year are expected to remain on course this year, with growth in the orphan drug market anticipated to increase from $190.8 billion in 2021 to $248.2 billion in 2026.1 25 January 2022
The British pricing and reimbursement agency has updated its guidance for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), broadening access to the therapy. 24 January 2022
Marking a milestone in the troubled development of novel RARγ agonist palovarotene, French drugmaker Ipsen has finally secured approval, in Canada, where the therapy will be marketed under the brand name Sohonos. 24 January 2022
Thousands of Hungarian patients may have better life prospects after a decision was made again to include new therapies to the social security subsidy system following a two-year pause. As a result, 31 new medicines or indications will now be available under regular subsidy thanks to a regulation published at the end of December. 24 January 2022
In Latin America as with across the globe, the pharmaceutical sector works to consolidate a solid scheme of protection of intellectual property (IP), incentivizing a virtuous ecosystem generating technology and innovation, based on principles of trust and security. 21 January 2022
Global regulators have published a report on the effectiveness of current vaccines against the COVID-19 Omicron variant based on a workshop held under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). 21 January 2022
Russian drugmaker Nanolek continues the production of CoviVac, the vaccine which was developed by the country’s Chumakov Federal Scientific Center, reports The Pharma Letter’s local correspondent. 21 January 2022
Once touted as a potential successor to Merck & Co’s former boss Kenneth Frazier, Frank Clyburn is to leave his post as the company’s executive vice president and president, Human Health, to take up a role elsewhere. 21 January 2022
The Russian government plans to stimulate the level of competition during public procurements of drugs for the domestic market, that will take place through the splitting of purchases and the introduction of limits on the volume of lots during state tenders. 21 January 2022
The European Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the European Union’s medicines regulator with 655 votes in favour, 31 against and eight abstentions. 21 January 2022
The equity research team at US financial services firm Morningstar has published the Annual Drug Pipeline report, which looks at the large-cap biopharma groups and their position in the market. 20 January 2022
Japanese drug major Daiichi Sankyo edged up 1.6% to 2,608 yen after it revealed it has entered into an agreement with Cosette Pharmaceuticals, whereby it divested and Cosette acquired rights for manufacturing, commercialization, and certain other rights for the following products in the USA: 20 January 2022
The Russian Direct Investment Fund (RDIF) has revealed the results of a study on the Sputnik V vaccine for COVID-19 and its effectiveness against the Omicron variant. 20 January 2022
Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), today announced the granting of provisional approval for US biotech firm Novavax’ COVID-19 vaccine. 20 January 2022
A positive decision from the European medicine regulator’s scientific panel makes another approval for the vasculitis med Tavneos (avacopan) likely. 20 January 2022