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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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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
Takeda logged a sales rise of 4.6% in April-December 2023 to 3,212.9 billion yen ($21.7 billion). 2 February 2024
Pharmaceutical
Supported by an impressive performance from its oncology and vaccine businesses, New Jersey, USA-based drugmaker Merck & Co topped forecasts in its latest results statement. 1 February 2024
Pharmaceutical
Clinical-stage US pharma company Protagonist Therapeutics' shares rose 6% to $26.5O in early trading, on news of a licensing deal for its blood disorder candidate rusfertide. 1 February 2024
Pharmaceutical
French pharma major Sanofi was trading 4% lower late Thursday after presenting its fourth quarter and full year 2023 financial results. 1 February 2024
Pharmaceutical
Privately-held Scotland-based EnteroBiotix has announced the appointments of Dr James Barnes as chief operating officer (COO) and Chris Lea as chief financial officer (CFO). 1 February 2024
Pharmaceutical
China-based Innovent Biologics recently made a significant breakthrough in obesity treatment with mazdutide, showcasing promising Phase III (GLORY-1) results. 1 February 2024
Pharmaceutical
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025. 31 January 2024
Pharmaceutical
British drugmaker GSK has exceeded expectations in the fourth quarter, with chief executive Dame Emma Walmsley presenting an upbeat view of the company’s trajectory. 31 January 2024
Pharmaceutical
Private company Defender Pharmaceuticals has had its submission for a new motion sickness treatment rejected by the US Food and Drug Administration. 31 January 2024
Pharmaceutical
US pharma giant Pfizer has presented its financial results for the fourth quarter and full year of 2023. 30 January 2024
Pharmaceutical
Vertex Pharmaceuticals today announced positive results from its Phase III program for the selective non-opioid selective NaV1.8 inhibitor V VX-548, in the treatment of moderate-to-severe acute pain. 30 January 2024
Pharmaceutical
Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock. 30 January 2024
Pharmaceutical
Having first authorized US pharma giant Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir and ritonavir) for emergency use, the US Food and Drug Administration (FDA) is now making another amendment. 30 January 2024
Pharmaceutical
Takeda has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP). 29 January 2024
Pharmaceutical
American biotech Exelixis and French partner Ipsen have announced detailed results from the Phase III CONTACT-02 trial. 29 January 2024
Pharmaceutical
Swedish pharma trade body Lif has welcomed a decision from authorities regarding the reimbursement model for innovative antibiotics. 29 January 2024
Pharmaceutical
E Merck KG, the company through which the Merck family holds around 70% of German pharma and life sciences company Merck KGaA, today announced the results of its regular board elections held this past weekend. 29 January 2024
Pharmaceutical
A response from the Ministry of the Interior and Health confirms that Denmark – compared to other European countries – has lower medical expenses per inhabitant, according to Danish trade group Lif. 29 January 2024
Pharmaceutical
Russia has faced a shortage of another important anticancer drug - Ixempra (ixabepilone), which is designed for the treatment of breast cahttps://mail.google.com/mail/cancer, reports The Pharma Letter’s local correspondent. 27 January 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others. 26 January 2024
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