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
Eisai’s US subsidiary has signed an exclusive licensing agreement with Uruguay-headquartered Grupo Biotoscana for Eisai's oncology and neurology products in Latin America. 5 October 2017
The UK High Court has rejected a bid from the the British pharma industry to prevent the National Institute for Health and Care Excellence from imposing new rules around price negotiations. 5 October 2017
In what is something of a criticism of the European Medicines Agency, a research team has found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better. 5 October 2017
Plenty of adjectives have been used to describe the transfer of six patents related to Allergan’s Restasis (cyclosporine ophthalmic emulsion) treatment for chronic dry eye disease to the Saint Regis Mohawk Tribe (SRMT). 4 October 2017
After a number of media leaks regarding the European Medicines Agency’s view of the rival member states’ bids, the agency has published its assessment in full. 4 October 2017
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
Russian and global pharmaceutical companies operating active substances’ production in Russia want to receive a premium of 40% of the value of the public procurements contracts signed with the Russian government, according to recent statements by Veronika Skvortsova, Russia’s Minister of Health, reports The Pharma Letter’s local correspondent. 4 October 2017
While the pharmaceutical industry is often regarded as being sluggardly in its embrace of change, opportunities in digital technology appear to be on the rise, and pharma is taking notice. 3 October 2017
In an Expert View piece, Balkrishan ‘BK’ Kalra, life sciences business leader and Eric Sandor, PVAI business leader, from technology and analytics specialist Genpact, look at how artificial intelligence is making drug development safer. 3 October 2017
Dr Nicola Davies explores pharmaceutical development in mental health, with a focus on factors that influence the road to pharma-psych innovation. 3 October 2017
Privately-held Swiss drugmaker Ferring Pharmaceuticals has appointed Professor Klaus Dugi as executive vice president and chief medical officer (CMO), effective immediately. 3 October 2017
An analysis from the investment research firm Zacks has considered the impact that US President Donald Trump’s proposed tax reforms could have on large-cap pharma companies based in the USA. 2 October 2017
Anger has been stirred up by a Journal of the American Medical Association (JAMA) article on the estimated research and development (R&D) spending for developing a cancer drug that potentially makes a mockery of previous claims from pharma on how much the process costs. 2 October 2017
Biohaven Pharmaceutical today reported disappointing top-line results from its Phase II/III clinical trial evaluating trigriluzole compared to placebo for the treatment of patients with spinocerebellar ataxia (SCA). 2 October 2017
French pharma major Sanofi today announced the appointment of Stefan Oelrich as executive vice president Diabetes & Cardiovascular (DCV), effectively immediately. 2 October 2017
Merck & Co has decided to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection, an ever more crowded therapeutic space. 2 October 2017
The commitment to transparency, contribution to the sustainability of the healthcare system and investment in research and development are the three pillars on which the social commitment of the innovative pharmaceutical industry in Spain is based, according to the local trade group. 2 October 2017
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
US Health and Human Services Secretary Tom Price sent this letter to President Donald Trump as he resigned Friday in the midst of a scandal over his use of private planes, racking up bills estimated at nearly a million dollar in taxpayer-funded travel since taking office in February, according CNN. 30 September 2017
Science writer David Levine provides the latest quarterly Special Report piece, looking at the drug prices in one therapy area that are getting on people's nerves so much that they might prompt drastic action from the White House to bring down the cost of medicines across the board. 29 September 2017