9 January 2025 Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare.
German pharma major Bayer today announced top-line results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in women at high risk of developing breast cancer. 9 January 2025
Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare. 9 January 2025
UK headquartered Verdiva Bio Limited today announced its launch as a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and other cardiometabolic disorders. 9 January 2025
Italy-based Newron Pharmaceuticals (SIX: NWRN, XETRA: NP5), a biopharma developing therapies for diseases of the central and peripheral nervous system, has announced a deal with South Korea’s Myung In Pharm. 9 January 2025
German family-owned pain focused drugmaker Grünenthal announced today that Prof Dr Uli Brödl will assume the role of chief scientific officer (CSO) and a member of the corporate executive board, effective February 1, 2025. 9 January 2025
Insilico Medicine, a biotechnology firm specializing in artificial intelligence-powered drug discovery, has raised over $100 million in a series E funding round. 8 January 2025
Calico Life Sciences, a biotech founded by Alphabet and Arthur Levinson focused on the biology of aging and age-related diseases, has announced a setback. 8 January 2025
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
Antag Therapeutics, a Denmark-based biopharma developing novel treatments for obesity, has announced the appointment of Joerg Moeller as chief executive officer, effective immediately. 8 January 2025
Metsera today announced positive data from a 12-week Phase IIa clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA). 7 January 2025
Central nervous system (CNS) specialist Neuraxpharm Group has acquired Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 7 January 2025
Japan-based FUSO Pharmaceutical Industries and Australia’s Dimerix Limited have entered into an exclusive development and license agreement for the development and commercialization of Dimerix’ Phase III drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. 7 January 2025
The heart failure market is projected to grow at a compound annual growth rate of 9.6% over the next decade, increasing from $13.5 billion in 2022 to $33.7 billion in 2032 across seven major markets, according to a report from analytics firm GlobalData. 7 January 2025
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
The European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 4 December 2023
A report from researchers at The University of New South Wales, in Australia, highlights significant progress towards the elimination of hepatitis C, while cautioning that “more work is needed” to completely eradicate the disease. 4 December 2023
Stimulants, amphetamines and methylphenidates continue to dominate the attention deficit hyperactivity disorder (ADHD) market across the seven major markets (7MM), serving as the primary pharmacological treatment. 4 December 2023
Japanese drugmaker Ono Pharmaceutical has announced that, in order to accelerate the open innovation, it has increased its investment pool from $100 million to $200 million. 4 December 2023
The US Food and Drug Administration (FDA) on Friday approved another indication for Jaypirca (pirtobrutinib, 100mg and 50mg tablets) from US pharm major Eli Lilly . 4 December 2023
The Environment and Civil Liberties committees adopted their position on creating a European Health Data Space (EHDS) to boost personal health data portability and more secure sharing. 4 December 2023
Another month has passed into the annals of history, but not without note, so far as the pharmaceutical M&A world is concerned, thanks to the announcement of a major deal by AbbVie. 1 December 2023
US pharma giant Pfizer saw its shares price fall 6.9% to $28.29 after it revealed mixed, but ultimately disappointing, clinical results for its obesity candidate danuglipron. 1 December 2023
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures for medicines containing pseudoephedrine. 1 December 2023
US biopharma Altimmune has entered the conversation about weight loss, joining the likes of Novo Nordisk and Eli Lilly by presenting positive data in the potentially lucrative field. 1 December 2023
UK pharma major AstraZeneca said today it has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate). 1 December 2023
Industry commentator GlobalData has produced research into growth in the pharma contract manufacturing sector, noting a strong increase in investments. 1 December 2023
Japanese pharma major Astellas today presented 24-week results from the Phase IIIb DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, at the 15th Congress of the European Society of Gynecology (ESG) in Amsterdam. 30 November 2023
Boston, USA-based biopharma Karuna Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults. 30 November 2023
Several Latin American countries, given their processes of political change, are immersed in deep discussions about transforming their health systems, writes The Pharma Letter's local correspondent. 29 November 2023
As political leaders from around the world get ready to meet at the COP 28 climate conference, life science companies are taking steps to encourage sustainability within industry. 29 November 2023
Industry lobbyist Pharmaceutical Research and Manufacturers of America (PhRMA) has criticized greater use of prior authorization in Medicaid. 29 November 2023
Swiss pharma giant Roche will resume the supply of its cystic fibrosis drug Pulmozyme (dornase alfa), as the company has found the way for its imports to the Russian market, The Pharma Letter’s local correspondent reports. 29 November 2023
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