Latest Pharma and Biotech News
Pharmaceutical
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.
Today's issue
Refine Search
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
All news
Pharmaceutical
There was good news for the makers of some diabetes and obesity drugs today, when the European regulator found no link to thyroid cancer scares. 27 October 2023
Pharmaceutical
US pharma major AbbVie’s shares were down 3.3% at $140.24 early today, after it released financial results for the third quarter of 2023. 27 October 2023
Pharmaceutical
Tokyo-headquartered pharma major Takeda has announced results for the first half of its fiscal year, which in Japan runs from April 1 to September 1. 27 October 2023
Pharmaceutical
Japanese drugmaker Otsuka today announced positive results of two, six-week, Phase III clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD). 27 October 2023
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday approved the new drug application (NDA) for Agamree (vamorolone) as a treatment of patients aged two years or more with Duchenne muscular dystrophy (DMD), that was submitted by Swiss drugmaker Santhera Pharmaceuticals. 27 October 2023
Pharmaceutical
Pharma giant Merck & Co was trading more than 2% higher Thursday lunchtime, as the firm released financial results. 26 October 2023
Pharmaceutical
US pharma giant Merck & Co has opted to pull the plug on two mid-stage trials of Alzheimer’s disease candidate MK-1942, due to safety worries. 26 October 2023
Pharmaceutical
US Pharma major Bristol Myers Squibb today reported results for the third quarter of 2023, which the company says reflect significant pipeline progress and advances in the portfolio renewal strategy. 26 October 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk recently revealed that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. 26 October 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. 26 October 2023
Pharmaceutical
USA-based BioXcel Therapeutics on Wednesday revealed that an independent third-party review of the data from a site in its TRANQUILITY II Phase III trial showed "positive findings." 26 October 2023
Pharmaceutical
Barcelona, Spain-based plasma-derived medicine specialist Grifols saw its shares close down more than 5% at 9.88 euros, despite announcing positive results for a potential Alzheimer’s vaccine candidate. 25 October 2023
Pharmaceutical
UK pharma major GSK (LSE: GSK) today announced positive preliminary results from its Phase III trial the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59. 25 October 2023
Pharmaceutical
French biotech Abivax has completed an initial public offering (IPO), listing on the Nasdaq global market with 20,325,500 new ordinary shares being issued. 25 October 2023
Pharmaceutical
The US Food and Drug Administration yesterday approved Tibsovo (ivosidenib), from French independent pharm major Servier, for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. 25 October 2023
Pharmaceutical
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Pharmaceutical
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma announced. 24 October 2023
Pharmaceutical
Seven vaccine research proposals have been chosen for funding, the latest development in a partnership between the Bill and Melinda Gates Foundation and the National Natural Science Foundation of China (NSFC). 24 October 2023
Pharmaceutical
Novartis has lifted its 2023 earnings forecast for the third time. 24 October 2023
Pharmaceutical
In October 2022, the US Food and Drug Administration (FDA) released its “Multiple Endpoints in Clinical Trials” document to provide guidance for drug sponsors and other stakeholders regarding best practices in assessment methodologies for medications. 24 October 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze