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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.
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USA-based Viatris said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA). 12 March 2024
Pharmaceutical
Danish firm Novo Nordisk has announced positive results from the kidney outcomes trial FLOW, in which Ozempic (semaglutide) 1mg reduced the risk of kidney disease progression and the risk of kidney and cardiovascular deaths by 24%. 12 March 2024
Pharmaceutical
A final report for KarXT (xanomeline tartrate/trospium chloride) has been published by influential US pricing watchdog The Institute for Clinical and Economic Review (ICER). 12 March 2024
Pharmaceutical
India's Department of Pharmaceuticals introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme aimed at enhancing the technological prowess of the country's pharmaceutical sector to meet global standards. 12 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Pharmaceutical
On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. 12 March 2024
Pharmaceutical
Israel-based RedHill Biopharma has announced the issuance of a new US patent related to Talicia (omeprazole/amoxicillin/rifabutin). 11 March 2024
Pharmaceutical
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024
Pharmaceutical
In a new report, The World Health Organization (WHO) has warned of growing resistance to certain HIV medications, while the overall picture on combating the disease remains positive. 11 March 2024
Pharmaceutical
Privately-held German firm Boehringer Ingelheim and Japan’s Sosei Group Corporation have entered into a global collaboration and exclusive option-to-license agreement. 11 March 2024
Pharmaceutical
Data protection is in the spotlight in Europe, as lawmakers gather to decide on an important set of rules on intellectual property, the Regulatory Data Protection (RDP) law. 11 March 2024
Pharmaceutical
Germany’s Bayer has entered into deal with USA-based BridgeBio Pharma to commercialize its cardiovascular candidate acoramidis worth $310 million in upfront and milestone payments. Research news last week included Denmark’s Novo Nordisk releasing positive new data on its semaglutide, showing it cut kidney-disease related events in diabetes patients by 24%. Also, Singapore-based TauRx Pharma released new data on its Alzheimer’s candidate hydromethylthionine mesylate (HMTM). US President Joe Biden is moving further with his intent to bring down drug prices in the USA, with plans not to limit Medicare negotiations to just 20 drugs a year. 10 March 2024
Pharmaceutical
In another win for Denmark’s Novo Nordisk, the US Food and Drug Administration approved a new indication for use for its Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. 9 March 2024
Pharmaceutical
With demand for GLP-1 agonists outstripping supply, Zepbound (tirzepatide) developer Eli Lilly has issued a warning against resorting to counterfeits. 8 March 2024
Pharmaceutical
Massachusetts, USA-based Amylyx Pharmaceuticals has announced topline results from the Phase III PHOENIX study. 8 March 2024
Pharmaceutical
Research undertaken by Californian antiviral specialist Gilead Sciences and fellow American company Merck & Co is moving in the right direction, new data show. 8 March 2024
Pharmaceutical
An analysis of recent pharma activity in the metabolic diseases field and why obesity is a hot topic amongst investors. 8 March 2024
Pharmaceutical
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals has appointed Ramiro Ribeiro as its new chief medical officer. 8 March 2024
Pharmaceutical
Singapore-based TauRx Pharmaceuticals, which is seeking treatments for Alzheimer’s and related neurodegenerative diseases, presented the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM). 8 March 2024
Pharmaceutical
Novo Nordisk’s investments in GLP-1 agonism and related approaches to weight loss are continuing to bear fruit, as shown by striking headline data from the STEP-1 trial. 8 March 2024
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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
Pharmaceutical
A team of Chinese researchers has identified a promising candidate for glaucoma treatment using artificial intelligence tools. 6 January 2025
Pharmaceutical
Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market. 6 January 2025
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