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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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US AI-enabled drug discoverer VantAI has entered into a strategic collaboration with pharma major Bristol Myers Squibb to discover new molecular glues for therapeutic targets of interest. 14 February 2024
Pharmaceutical
Novo Nordisk has come out on top in two cases in Florida courts relating to its weight loss drug Wegovy (semaglutide). 13 February 2024
Pharmaceutical
KalVista Pharmaceuticals shares, which closed Monday at $16.04, were recently up 37% to $22 in pre-market activity, but fell back almost 13% to $14.01 by late morning today, after it released new research data. 13 February 2024
Pharmaceutical
Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Pharmaceutical
Shares of Japanese drugmaker Otsuka Pharmaceutical fell more than 5% to 5,359 yen today, as it released top line results of the Phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease. 13 February 2024
Pharmaceutical
The Yellow Card Biobank, a pilot launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, is to start investigating a group of medicines used to prevent strokes known as direct oral anticoagulants (DOACs). 13 February 2024
Pharmaceutical
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
Pharmaceutical
Foghorn Therapeutics has announced that its partner, Eli Lilly has selected FHD-909, a first-in-class oral BRM selective inhibitor, for clinical development. 12 February 2024
Pharmaceutical
The USA-based AMR Industry Alliance conducted a review of publicly available data on the state of antimicrobial resistance (AMR) research and development talent. 12 February 2024
Pharmaceutical
CymaBay Therapeutics’ shares surged 24.5% to $31.99 pre-market, on the news of an acquisition bid from US major Gilead Sciences. 12 February 2024
Pharmaceutical
Danish drugmaker Lundbeck has its eye on steady growth over the medium term, a strategy which new chief executive Charl van Zyl believes could be key to the firm’s future success. 12 February 2024
Pharmaceutical
UK-based Poolbeg Pharma has announced that research conducted on its behalf confirms a market opportunity of at least $10 billon for POLB 001 in cancer immunotherapy-induced cytokine release syndrome (CRS) as an orally-delivered preventative therapy. 12 February 2024
Pharmaceutical
Spanish plasma-derived products specialist Grifols has announced that Raimon Grifols and Víctor Grifols Deu have chosen to step down from their executive functions – chief corporate officer and chief operating officer, respectively. 12 February 2024
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Pharmaceutical
Japan’s largest drugmaker Takeda Pharma has announced positive top-line results from a randomized, double-blind, placebo-controlled, multiple dose Phase IIb trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. 9 February 2024
Pharmaceutical
Vicor Pharma has entered into an exclusive licensing agreement with Japan’s Nippon Shinyaku, for the commercialization and development of its C21 idiopathic pulmonary fibrosis (IPF) drug candidate in Japan. 9 February 2024
Pharmaceutical
Despite posting positive clinical trial results for its resmetirom, being trialled in the treatment of non-alcoholic steatohepatitis (NASH,) US drug developer Madrigal Pharmaceuticals saw its shares close down more than 9% at $173.71 yesterday. 9 February 2024
Pharmaceutical
Californian biotech Corvus Pharmaceuticals has appointed Jeffrey Arcara as chief business officer. 8 February 2024
Pharmaceutical
In an Expert View piece, Mark Seymour, Director and Head of Media, Healthcare, at FleishmanHillard London, argues that in the ever-evolving world of healthcare, the rules of communications have not changed, they have just become more intricate, demanding a renewed focus on the essentials. 8 February 2024
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca was trading 5% lower at lunchtime in London on Thursday. 8 February 2024
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Pharmaceutical
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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