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 cloud continues to loom over the implementation of the Unified Patent Convention, a system permitting a single patent covering numerous European countries, writes barrister Mark Engelman, head of intellectual property at UK-based law firm, Hardwicke, in an Expert View piece. 11 October 2017
Three of Japan’s largest pharmaceutical firms today announced they will collaborate in facilitating drug discovery in Japan through open innovation sharing of compounds developed by the companies. 11 October 2017
Research carried out at the National Institute of Allergy and Infectious Diseases in the USA suggests that an end to the HIV/AIDS pandemic will only be possible with the development of an effective HIV vaccine. 11 October 2017
In another Big Pharma move to realign their operations, US giant Pfizer yesterday announced that it is reviewing strategic alternatives for its Consumer Healthcare business. 11 October 2017
In early 2016, the USA’s Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B, according to McKenzie Cato and David Gibbons writing on Hyman, Phelps & McNamara on its FDA Law Bog. 11 October 2017
East Coast protease inhibitor specialist KalVista Pharmaceuticals has signed a deal with Merck & Co, sending shares in the thinly-traded startup through the roof. 10 October 2017
The China Food and Drug Administration has announced far-reaching reforms to its regulatory system, that are expected to speed up approvals of medical technologies in the country. 9 October 2017
US pharma major Bristol-Myers Squibb (NYSE: BMY) has appointed scientific and business thought-leader, Saurabh Saha, senior vice president and global head of translational medicine in the company’s R&D organization, effective today. 9 October 2017
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Even as French pharma giant Sanofi has stalled development work on a Zika virus vaccine candidate, India is pushing ahead with two vaccine candidates against the virus that continues to cause havoc across the world, and could cause Alzheimer's style symptoms in adults, reports The Pharma Letter’s India correspondent. 9 October 2017
The level of rebates and claw-backs that pharmaceutical companies in Greece are required to pay is unique by European standards and indicative of the over-taxation that is killing the industry. 9 October 2017
The packaging of prescription-only medicinal products must have safety features from February 9, 2019 onwards, the Dutch Medicines Evaluation Board (CBG) has reminded players. 9 October 2017
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
Kitov Pharmaceuticals has acquired an additional 27% stake in TyrNovo, a privately-held developer of novel small molecules in the oncology therapeutic field, from unaffiliated minority shareholders, also based in Israel. 6 October 2017
Life sciences companies are facing familiar business risks, according to their most recent 10-K filings. But revolutionary forces - driven by innovations in technology, regulatory bodies, consumers, legislators and healthcare providers - will require new ways of thinking about risk mitigation. 6 October 2017
Yet another congressional push to repeal and replace the Affordable Care Act has failed as, for a second time, Republicans opted to withdraw proposals rather than face the humiliation of defeat. 6 October 2017
At present, two out of three people diagnosed with cancer survive at least five years. Between 1991 and 2011 deaths from cancer have fallen by 21% across the EU5 (UK, France, Germany, Spain and Italy). 6 October 2017