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
Sygnature Discovery, which claims to be the UK’s largest independent drug discovery expert and research partner, has been appointed by UCL to lead an optimization project targeting pancreatic cancer. 4 August 2017
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has issued draft guidance recommending Skilarence (dimethyl fumarate). 4 August 2017
The US Food and Drug Administration has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. 4 August 2017
A package of new and updated guidance on licensing and certification processes for manufacturers of medicines and biologicals in Australia, has been developed in consultation with the Therapeutic Goods Administration (TGA) Industry Working Group on GMP (TIWGG), to better support manufacturers and sponsors and provide additional clarity for applicants. 4 August 2017
German life sciences major Merck KGaA has posted an increase in net sales for the second quarter of 2017, up 2.3% from the same period last year at 3.9 billion euros ($4.6 billion), slightly higher than analysts had expected. 3 August 2017
CVS Caremark has released its 2018 formulary, revealing 17 drugs will be removed from the list next year, including Merck & Co’s Zetia, Daiichi Sankyo’s Benicar and Teva Pharmaceutical’s Nuvigil. 3 August 2017
USA-based Collidion has entered into a definitive agreement to acquire an 80% equity stake in Plex Pharmaceuticals (formerly known as CalAsia) in exchange for an undisclosed amount of cash and contributing a novel drug asset under development. 2 August 2017
There was a summer slowdown in the pace of pharma and biotech mergers and acquisitions during July, and it is likely to continue into August. 2 August 2017
The application procedure to host the two UK-based European Union agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight on July 31, 2017, the European Commission announced yesterday, thus firing the starting gun for bids from various European cities to become the location for these important regulatory agencies. Some 19 cities have posted formal bids to host the EMA post Brexit. 2 August 2017
Japanese pharma major Daiichi Sankyo (TYO: 4568) and its US subsidiary have agreed to enter into a program to settle, on behalf of all defendants, pending product liability litigation against various Daiichi Sankyo and Forest entities. 2 August 2017
Pfizer, the world’s biggest pharma company, has beaten earnings expectations but fallen short of analysts’ sales predictions in its latest quarterly results. 1 August 2017
The enforcement of a much more stringent pricing revision policy in Japan, both for new products as well as off-patent brands, is behind the decline of the products currently on the market which are forecast to drop about 2% annually in sales through 2022, a new report shows. 1 August 2017
Twenty-first century data is providing the data-heavy pharma industry with a modern dilemma: how to preserve corporate information when technological development is accelerating so fast, writes Dominic Johnstone, head of information management services at Crown Records Management. 1 August 2017
The European Medicines Agency is inviting comments from the public on a reflection paper on how medicine developers can better address the needs of older people who need to take medicines. 1 August 2017
Foreign pharma companies began a major push into the Japan market in the 1950s, albeit in the form of joint ventures (JVs) since ownership above 50% was not permitted, writes long-time Japanese industry watcher P Reed Maurer, president of International Alliances Limited, in his exclusive column for The Pharma Letter. 1 August 2017
In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA). The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business. 1 August 2017