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
For years, pharmaceutical companies have struggled to develop new treatments for the second most common type of leukemia diagnosed in adults and children, acute myeloid leukemia (AML). 1 March 2018
After presenting annual financial results and 2018 guidance that disappointed investors on Wednesday, the debt-ridden Canadian drugmaker Valeant Pharmaceuticals International can at least point to a new potential revenue stream in the future. 1 March 2018
The European Medicines Agency (EMA) has taken a step closer to formalizing its move to Amsterdam after accepting the pledge of the Dutch government that its brand new, tailor-made premises will be ready in the city by November 2019. 1 March 2018
The head of Japanese pharma major Astellas’ (TYO: 4503) US operations is moving to take up a top position at US CNS focussed drugmaker Alkermes (Nasdaq: ALKS). 1 March 2018
Geopolitical stability, gradually rising living standards and the introduction of universal healthcare systems is fuelling investor interest across South East Asia – particularly for Indonesia, which is home to the largest and fastest growing market. 1 March 2018
After a US appeals court last year ruled against Helsinn Healthcare in its patent dispute with Israel’s Teva Pharmaceutical Industries, the Swiss company has now announced it will take its legal battle to the highest court in the land. 1 March 2018
Children and rare disease patients could be excluded from lifesaving clinical trials and networks when the UK leaves the European Union, according to the Brexit Health Alliance. 1 March 2018
After a strong third quarter in which Valeant Pharmaceuticals chipped away at its worryingly large debt mountain and posted strong profits courtesy of a one-off tax benefit, the Canadian drugmaker has disappointed investors with a less encouraging full year report. 28 February 2018
Investors in Akorn had a wake-up call yesterday, as Germany-based Fresenius raised doubts about its acquisition of Akorn amid a Food and Drug Administration enquiry into alleged allegations of FDA integrity requirements relating to product developments 28 February 2018
Continued growth in the Pharmaceuticals unit provided some rare cheer for German life sciences group Bayer as it presented its 2017 financial results. 28 February 2018
Mumbai’s Cipla has agreed a distribution deal with Roche’s Indian business to sell Actemra (tocilizumab) and Syndyma (bevacizumab), also marketed as Avastin, in the country. 28 February 2018
East Coast, USA-based Melinta Therapeutics has published positive results from the Phase III TANGO I study of Vabomere (meropenem and vaborbactam). 28 February 2018
A federal jury in New Jersey has ruled against Biogen and in favor of Pfizer and collaboration partner Merck KGaA in an eight year legal battle over competing multiple sclerosis medications. 27 February 2018
As Rare Disease Day approaches, the US FDA has released a statement outlining steps the agency is taking to promote the development of therapies in this area. 27 February 2018
The newly appointed secretary of the US Health and Human Services (HHS), Alex Azar, has outlined concrete steps his agency plans to take to combat the country’s opioid addiction epidemic. 27 February 2018
Eli Lilly has been granted US FDA approval for Verzenio (abemaciclib) in a new indication, expanding the marketable treatments for the therapy to include initial endocrine-based therapy for certain metastatic breast cancer patients, in combination with an aromatase inhibitor (AI). 27 February 2018
With the USA’s flu epidemic apparently subsiding, the FDA’s Commissioner Scott Gottlieb has provided an update on his agency's efforts to improve the effectiveness of influenza vaccines. 27 February 2018
The Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved the registration of Mavenclad (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. 27 February 2018
Portugal’s largest drugmaker BIAL today announced an exclusive license agreement for the commercialization of Zebinix (eslicarbazepine acetate) in South Korea. 27 February 2018