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
The European Commission, the US Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. 23 August 2017
A $66 billion takeover bid for a US agriculture firm from German life sciences company Bayer is being investigated by the European Commission (EC) amid concern that it might harm competition. 23 August 2017
Dr Reddy’s Laboratories, through its wholly-owned US subsidiary Promius Pharma, has out-licensed the future development, manufacturing and commercialization rights of DFD-06, a topical high potency steroid, to Encore Dermatology. 23 August 2017
While the signing of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) was not the the action of US President Donald Trump that garnered most headlines last week, it has undoubted importance for the drug development industry. 22 August 2017
The Indian Patent Office has granted US drug giant Pfizer (NYSE: PFE) a patent for its blockbuster vaccine, Prevenar 13 (pneumococcal 7-valent conjugate), used to protect children against pneumococcal diseases. 22 August 2017
The drug development industry has welcomed the UK government’s position paper seeking a smooth and orderly withdrawal from the European Union (EU) in regard to the availability of goods, in a way that supports the move to the freest possible future economic relationship. 22 August 2017
Australia’s St Vincent’s Institute of Medical Research (SVI) in Melbourne, has entered into a collaboration and license agreement with Janssen Pharmaceuticals. 22 August 2017
US Food and Drug Administration Commissioner Scott Gottlieb says there’s perhaps no more important mandate that the FDA has than safeguarding the health and safety of children. 22 August 2017
Swiss pharma giant Novartis and Medicines for Malaria Venture, a not-for-profit public-private partnership, have launched a trial in Africa for KAF156, a novel compound against multidrug-resistant malaria. 21 August 2017
The global melanoma therapeutics market is expected to reach $12.4 billion by 2025, according to a new report by Grand View Research. The increasing incidence of chronic diseases such as melanoma, skin cancer and skin allergies is an important driver of the market. 21 August 2017
Eliciting considerable comment last week was news of UK pharma major GlaxoSmithKline pulling out of its deal with Ionis Pharmaceuticals on inotersen; Mylan reaching a settlement with the US Justice Department over classification of its EpiPen; another setback for Ophthotech’s eye drug Fovista; expanded indications for AstraZeneca and Merck & Co’s cancer drug Lynparza; and US approval for Pfizer’s leukemia treatment Besponsa. 20 August 2017
On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices. 19 August 2017
Nigeria’s Minister of Health, Isaac Adewole, has said the federal government is determined to stop the sale of drugs in open markets in the country at the end of 2018. 19 August 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing the way statements about drug safety are presented in pharmaceuticals advertising. 18 August 2017
Swedish drugmaker Medivir said today that it has licensed the exclusive rights for China to develop, manufacture and commercialize its nucleotide polymerase inhibitor for hepatitis C, MIV-802 to domestic biotech firm Ascletis. 18 August 2017
On the morning of August 16,2017, Wu Zhen, vice minister of the China Food and Drug Administration (CFDA), met with visiting Dr Ian Hudson, the chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and his delegation. 18 August 2017