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.
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
After first approving the drug in 2014 for the treatment of primary immunodeficiency (PI) in adults, the US Food and Drug Administration (FDA) has now approved a new indication for HyQvia [immune globulin Infusion 10% (Human) with recombinant human hyaluronidase]. 17 January 2024
Switzerland-based Stalicla, a biopharma advancing precision medicine pipelines for neuropsychiatric and neurological disorders, has announced the successful completion of the first closing of its Series B financing round, securing $17.4 million. 16 January 2024
The Indian government has urged the United States to enhance the frequency of inspections carried out by the US Food and Drug Administration (FDA) in India, aiming to boost pharmaceutical exports. 16 January 2024
German family-owned pharma major Boehringer Ingelheim has announced a further expansion and upgrade of its manufacturing plant in Koropi, Greece, where the pharmaceutical market is forecast to grow by 8.2%, from $7.5 billion in 2022 to $7.8 billion in 2023. 16 January 2024
French healthcare non-profit Médecins Sans Frontières (MSF) has called on European lawmakers to amend a proposed law which would result in an effective export ban. 16 January 2024
Earlier this month US biotech major Amgen presented at the JP Morgan’s 42nd Annual Healthcare Conference, highlighting its pillars of business. 15 January 2024
The European Medicines Agency (EMA) has adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in preschool children (3 months to 6 years old), the Brazilian research organization Fiocruz has announced. 15 January 2024
Industry analyst GlobalData has presented research into the growing market for GLP-1 therapies, noting the significance of Roche’s recent acquisition in this area. 12 January 2024
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the UK for Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 12 January 2024
US biopharma Emergent BioSolutions has secured a procurement contract with a maximum value up to $235.8 million to supply BioThrax (Anthrax Vaccine Adsorbed) for use by all branches of the US military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. 12 January 2024
The US Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. 12 January 2024
Privately-held Spanish drugmaker Ferrer has reported that the Phase III ADORE trial of oral edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) did not meet primary or key secondary endpoints. 11 January 2024
Grifols, the Spanish producer of blood plasma-based products, is not taking the stock market damage done to the company by UK short seller Gotham City Research without a fight. 11 January 2024
China’s Shanghai Henlius Biotech today announced a strategic collaboration with USA-based Sermonix Pharmaceuticals for exclusive rights to develop, manufacture and commercialize Sermonix’ lead investigational drug, lasofoxifene, in China. 11 January 2024
Swiss-American eye specialist Alcon has announced positive topline results from two Phase III trials evaluating the efficacy and safety of AR-15512. 11 January 2024