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
A new product will enter the increasingly competitive cardiovascular space, with approval in the USA for Merck & Co and Bayer’s Verquvo (vericiguat). 21 January 2021
Privately-held Seattle-based biopharma Impel NeuroPharma has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults. 20 January 2021
Anglo-Irish rare diseases specialist Amryt Pharma (LSE: AMYT) has won a positive reimbursement decision in the UK for Myalepta (metreleptin). 20 January 2021
Novartis’ Steven Baert, chief people and organization officer, and Elizabeth Theophille, chief technology transformation officer, provide an Expert View predicting what will dictate developments in the pharmaceutical and healthcare industries in 2021. 19 January 2021
Alzhiemer’s disease (AD) candidate troriluzole is in trouble, after a Phase II/III trial missed its co-primary endpoints, troubling the share price of developer Biohaven Pharmaceutical. 19 January 2021
The anti-cancer therapeutic sector will act as the major driver for growth for the Russian pharmaceutical market in 2021, as the demand for these drugs, particularly during state tenders remains stable, according to recent statements by some leading Russian pharma analysts and producers, reports The Pharma Letter’s local correspondent. 19 January 2021
The last quarter of 2020 saw the beginning of the roll-out of coronavirus vaccines in the quickest countries off the mark and saw some big biopharma M&A deals, most notably AstraZeneca's $39 billion buy of Alexion Pharmaceuticals. 18 January 2021
The ongoing investigation of the cyberattack on the European Medicines Agency (EMA) revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines have been leaked on the internet. 18 January 2021
Following the publication of what it says is inaccurate information by some media, that Sputnik V was denied an Emergency Use Authorization (EUA) in Brazil, the Russian Direct Investment Fund (RDIF) on Sunday issued a statement to clarify the situation. 18 January 2021
Last week saw the third M&A deal this year, with Sanofi announcing it proposes to buy UK immuno-oncology focussed biotech firm Kymab in a deal worth up to $1.45 billion. US pharma major Eli Lilly pleased the Alzheimer’s community, coming up with encouraging Phase II results for its candidate donanemab. Also, Swiss pharma giant Novartis entered into a license deal with Sino-American firm BeiGene to expand its immune-oncology portfolio. 17 January 2021
USA-based services provider Thermo Fisher Scientific said today it has completed the acquisition of Henogen, Novasep’s viral vector manufacturing business in Belgium. 15 January 2021
The US Department of Justice collected more than $2.2 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2020, Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division announced yesterday. 15 January 2021
French metabolic diseases biotech company Poxel (Euronext: POXEL) has announced that, as part of the previously communicated decision by Metavant not to advance imeglimin into a Phase III program for strategic reasons, its partnership agreement with Metavant will be terminated, effective January 31, 2021. 15 January 2021
New York’s Pfizer has broadened the US label for Xalkori (crizotinib), to include treatment of young adults and children over the age of 1 with anaplastic large cell lymphoma (ALCL). 15 January 2021
The UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE), today issued a final appraisal determination (FAD) recommending the use of Zejula (niraparib) on the National Health Service NHS in England for adult women with advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy. 15 January 2021
German life sciences company Bayer has made clear its long-term ambitions to be an industry leader in the field of cell and gene therapy. 14 January 2021
Struggling biotech Acorda Therapeutics has announced plans to sell a manufacturing site for one of its key assets, as part of a restructuring plan aimed at keeping the ship afloat. 14 January 2021
The International Court of Arbitration of the International Chamber of Commerce has ordered Korea’s Kolon Life Science to pay a total of $33 million to Mitsubishi Tanabe Pharma Corporation. 14 January 2021