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
Three corporate behemoths have hatched a plan to step in to the American healthcare market, with the aim of “improving employee satisfaction and reducing costs.” 31 January 2018
French pharma major Sanofi has asked the European Medicines Agency to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). 31 January 2018
The UK’s National Health Service (NHS) and other European healthcare providers should start administering quadrivalent vaccines to better protect against the influenza virus. 31 January 2018
In the second of two Expert View columns to whet the appetite for the eyeforpharma Barcelona event in March, Sanofi’s Chief Data Officer (CDO), Milind Kamkolkar, expounds the possibilities of digital and the role of the CDO in this burgeoning landscape. 31 January 2018
Remarks by US president Donald Trump at the swearing in ceremony of new HSS Secretary Alex Azar confirm his administration’s determination to drastically lower the price of prescription medications in the USA. 30 January 2018
While some including Johnson & Johnson (NYSE: JNJ) and Biogen (Nasdaq: BIIB) took hefty tax charges in the final part of 2017, New York’s Pfizer (NYSE: PFE) was one of those to benefit from US tax reforms, the firm’s annual results statement shows. 30 January 2018
The UK’s first stab at creating a Cancer Drugs Fund (CDF), to give patients access to oncology treatments not available on the National Health Service (NHS), became unsustainable after the Department of Health overspent the fund’s £480 million ($678 million) budget for two years between 2013 and 2015 by £167 million. 30 January 2018
US specialty drug firm Aradigm saw its shares plummet at much as 39% to $1.36 in morning trading on Monday, after it said it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Linhaliq. 30 January 2018
The pRED research base of Switzerland’s Roche has scored an R&D win in the form of US FDA Breakthrough status for balovaptan for autism spectrum disorder (ASD). 30 January 2018
Sunovion Pharmaceuticals has revealed positive top-line data from its Phase III trial of Parkinson’s disease (PD) candidate APL-130277. 30 January 2018
Looking back on the past year, last week the president of the Greek pharmaceutical industry association, SFEE, Pascal Apostolides, said that 2017 was a lost year, with missed opportunities and without substantial reforms. 30 January 2018
As a result of the UK leaving the European Union effective March 29, 2019, the relocation of the European Medicines Agency from London to Amsterdam in the Netherlands is likely to cause some logistic problems, the EMA executive director Guido Rasi explained at a meeting in The Hague with Dutch health authorities. 29 January 2018
The US Food and Drug Administration has approved Firvanq (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. 29 January 2018
Shanghai Pharma is set to expand to San Diego with a new R&D hub, and is also seeking to gain technology and market access “through the short-cut route of acquisitions,” chairman Zhou Jun told the South China Morning Post recently. 29 January 2018
China’s Food and Drug Administration recently issued many new polices to push healthcare reform and drug innovation in the country. One of them is to acknowledge foreign trial data and hire more staff to speed up Investigational New Drug (IND) and New Drug Applications (NDA) approval, writes The Pharma Letter’s China correspondent Wang Fangqing. 29 January 2018
Medicines Australia welcomes the government’s announcement of an outcome from the Post-market Review of the Life Saving Drugs Programme (LSDP review). 29 January 2018