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
Swiss pharma giant Roche today announced that Dr William Pao, head of Roche pharma research and early development (pRED) since 2018, has decided to leave Roche for a new opportunity and return to the USA, effective March 18, 2022. 2 February 2022
Danish diabetes giant Novo Nordisk has reported net sales of 140 billion kroner ($21.3 billion) in 2021, an 11% increase from the year before. 2 February 2022
The top 20 global innovative biopharma companies had a favorable year in 2021, reporting a 24.9% growth in aggregate market capitalization (MCAP), according to GlobalData. 1 February 2022
Byannli (paliperidone palmitate) has been approved in Great Britain for the maintenance treatment of schizophrenia in adults who are clinically stable on one-monthly or three-monthly paliperidone palmitate. 1 February 2022
Pennsylvania, USA-based liver disease specialist Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced positive results from a trial in non-alcoholic steatohepatitis (NASH). 1 February 2022
New jobs in the UK life sciences sector hit all-time highs in 2021 amid a record injection of government healthcare funding to position Britain as a global life sciences superpower post-Brexit, according to new research. 1 February 2022
The first month of the year is often one of the busiest for the announcement of mergers and acquisitions (M&A) in the pharmaceutical sector. 31 January 2022
Thousands of those most at-risk to COVID-19 will soon be able to access the UK’s second ground-breaking antiviral, the Department of Health and Social Care announced on Friday. 31 January 2022
Tokyo-based drugmaker Kyowa Kirin has submitted for Japanese approval for Mitomycin-C (mitomycin) as a topical ophthalmic drug for use in glaucoma surgery. 31 January 2022
Japanese drug major Shionogi edged up 2.4% to 6,464 yen this morning, as it presented the results up to day six of the Phase IIa part of a Phase II/III clinical trial of S-217622, an orally administered antiviral drug for COVID-19. 31 January 2022
French ophthalmology specialist Laboratoires Théa has signed an agreement to purchase seven branded ophthalmic products from Akorn Operating Company. 31 January 2022
US pharma Eli Lilly saw its shares close up 3.5% at $245.10 on Friday, after it announced plans to significantly expand production facilities in the USA and Ireland. 29 January 2022
Following the January meeting of the European Medicines Agency’s Medicinal Products for Human Use (CHMP) several drug recommendations were announced. 28 January 2022
Trade group Medicines Australia has called for the country’s government to deliver a plan that shortens the time that patients wait for access to the latest innovative treatments and vaccines. 28 January 2022
Texan firm TFF Pharmaceuticals, a biopharma developing and commercializing drugs based on its thin film freezing technology platform, has completed enrollment of 40 healthy subjects in its Phase I trial of a dry powder formulation of niclosamide, an antiviral with potential in COVID-19 and other respiratory viral diseases. 27 January 2022
Steve Kent, chairman at Pharmaspectra, a data business with a focus on medical affairs, provides an Expert View on the increasing impact of data in medicine. 27 January 2022
A 30% drop in the share price of Alzheimer’s specialist Cortexyme has followed news of an abrupt change to its clinical research priorities. 27 January 2022
Russia plans to begin the production of a scarce drug based on ethosuximide for the treatment of epilepsy, according to recent statements by some of local analysts in the field of pharmaceutics and Russian media, reports The Pharma Letter’s local correspondent. 26 January 2022
Swiss contract development and manufacturing organization (CDMO) Lonza has reported full-year 2021 sales of 5.4 billion francs ($5.9 billion). 26 January 2022