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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.
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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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
British pharma major AstraZeneca has received positive news from the reimbursement from the UK’s health technology assessor. 9 January 2025
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
The US Food and Drug Administration has imposed a label change for two new respiratory syncytial virus (RSV) vaccine rivals. 8 January 2025
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
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Pharmaceutical
Lif, the industry organization for Danish and foreign pharmaceutical companies in Denmark, has held a debate to discuss access to new medicines. 18 December 2023
Pharmaceutical
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the European Union (EU) to treat Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 18 December 2023
Pharmaceutical
Hot on the heels of approval from the European regulator, the UK subsidiary of Japan’s Astellas Pharma today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Veoza (fezolinetant). 18 December 2023
Pharmaceutical
At a briefing session of Oireachtas, Ireland's national parliament, TDs and Senators heard of the human impact of delayed access to new, innovative medicines and the consequences for patients of no dedicated funding. 18 December 2023
Pharmaceutical
Neuroscience-focused biopharma Alkermes has entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Danish pharma major Novo Nordisk for $92.5 million. 15 December 2023
Pharmaceutical
Two years after Welireg's (belzutifan) original approval in the rare von Hippel-Lindau (VHL) disease, the Food and Drug Administration has now approved the Merck & Co drug for a new indication. 15 December 2023
Pharmaceutical
US drugmakers Melinta Therapeutics and Cidara Therapeutics recently released extensive data from two global clinical trials on their candidemia and invasive candidiasis drug Rezzayo (rezafungin acetate). 15 December 2023
Pharmaceutical
Shares in Glaukos Corporation closed more than 25% higher on Thursday. 15 December 2023
Pharmaceutical
Shares in Californian rare disease company Reneo Pharmaceuticals have plummeted after the firm announced the failure of its pivotal STRIDE study. 15 December 2023
Pharmaceutical
As a result of US President Biden’s much industry contested prescription drug law, the Inflation Reduction Act, drug companies will pay rebates to Medicare when prices of certain prescription drugs administered or dispensed to people with Medicare increase faster than the rate of inflation. 15 December 2023
Pharmaceutical
Following a broadly positive advisory committee vote in October, the US Food and Drug Administration now approved US WorldMeds, Iwilfin (eflornithine). 15 December 2023
Pharmaceutical
New York-based neurology specialist Mind Medicine has announced positive topline results from its Phase IIb clinical trial of MM-120. 14 December 2023
Pharmaceutical
Swiss neurology specialist GliaPharm has announced a new investment of $4.2 million for its lead program in Alzheimer’s disease. 14 December 2023
Pharmaceutical
The Global Health Innovative Technology (GHIT) Fund has announced an investment of approximately $8.8 million for the development of new drugs for malaria and Chagas disease. 14 December 2023
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the establishment of a new Genetic Metabolic Diseases Advisory Committee (GeMDAC) to help the agency explore the complex issues related to genetic metabolic disease drug development. 14 December 2023
Pharmaceutical
Rare disease drug development has grown exponentially in recent years, and 2023 has continued to expand on this trend.1 13 December 2023
Pharmaceutical
Russia has faced a shortage of Jaquinus/Xeljanz (tofacitinib), a drug to treat rheumatoid arthritis from US pharma giant Pfizer, reports The Pharma Letter’s correspondent. 13 December 2023
Pharmaceutical
In 2023, the number of drugs approved by the US Food and Drug Administration (FDA) rose, following a sparse year in 2022. 12 December 2023
Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first version of the Union list of critical medicines. 12 December 2023
Pharmaceutical
Cancer Research UK has appointed industry veteran Dr Lars Erwig as the new director for its Centre for Drug Development, the world's only charity-funded drug development facility. 12 December 2023
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