Latest Pharma and Biotech News
Pharmaceutical
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.
Today's issue
Refine Search
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
Pharmaceutical
Immedica Pharma, a Swedish company specializing in rare diseases, has announced its acquisition of Marinus Pharmaceuticals in a deal valued at $151 million. The agreement, finalized through a cash tender offer, marks a significant expansion of Immedica’s presence in the US market. 6 January 2025
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca has announced that new, positive, long-term results from the pivotal ALPHA Phase III trial have appeared in the journal Blood, which is published by the American Society of Hematology. 6 January 2025
Pharmaceutical
Alon Natanson, a business leader and alumnus of the Hebrew University of Jerusalem, has been appointed chief executive officer (CEO) of Yissum, the Israeli Hebrew University Tech Transfer company. 6 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
All news
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam. 26 February 2024
Pharmaceutical
UK pharma major GSK today announced positive headline results from the pivotal EAGLE-1 Phase III trial for gepotidacin. 26 February 2024
Pharmaceutical
The US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
Pharmaceutical
Biotech company United Therapeutics Corporation has launched a lawsuit against the US Food and Drug Administration (FDA). 23 February 2024
Pharmaceutical
Danish CNS specialist Lundbeck today announced a number of changes in its executive management team, first noting that Jacob Tolstrup, executive vice president, commercial operations, will leave the company no later than March 1, 2024. 23 February 2024
Pharmaceutical
Italian pharma major Recordati saw its shares dip 1.5% to 51.30 euros today, despite releasing a strong set of financial results for full year 2023. 22 February 2024
Pharmaceutical
Japanese drugmaker Shionogi today revealed that it has received approval from the Taiwan Food and Drug Administration (TFDA) for Fetroja (cefiderocol) in the treatment of complicated urinary tract infections. 22 February 2024
Pharmaceutical
German family-owned drugmaker InfectoPharm Arzneimittel und Consilium GmbH has set up a further European subsidiary – this time in France. 22 February 2024
Pharmaceutical
ViiV Healthcare today announced results from an interim analysis of the LATITUDE Phase III trial, indicating its long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy. 21 February 2024
Pharmaceutical
India's pharma landscape has undergone a significant shift towards collaboration and partnership between global big pharma and domestic firms in recent years to drive innovation and expand market reach, according to GlobalData. 21 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) submitted by pharma major Bristol Myers Squibb for Krazati (adagrasib) in combination with cetuximab. 21 February 2024
Pharmaceutical
GlobalData has taken a look at shifts in market capitalization among the world’s top 20 biopharma companies during 2023. 20 February 2024
Pharmaceutical
US pharma major AbbVie today announced a succession plan, to replace its current chief executive (CEO). 20 February 2024
Pharmaceutical
Indian drugmaker Cipla Limited has entered into a collaborative research agreement with CSIR-Central Drug Research to jointly develop a novel ophthalmic formulation for fungal keratitis. 20 February 2024
Pharmaceutical
Australia’s Starpharma has announced that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel BV (SPL7013/astodrimer sodium). 20 February 2024
Pharmaceutical
German pharma and crop sciences major Bayer plans to amend its dividend policy to pay out the legally required minimum for three years. 20 February 2024
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Velsipity (etrasimod) to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC). 19 February 2024
Pharmaceutical
Spanish dermatology company Almirall has announced its annual 2023 financial results. 19 February 2024
Pharmaceutical
Japan’s Ono Pharmaceutical today announced that it has entered into a research collaboration agreement with USA-based artificial intelligence (AI) company to identify novel therapeutic targets by leveraging cutting-edge InveniAI’s AI and machine learning (ML). 19 February 2024
Pharmaceutical
Japanese drugmaker Kyowa Kirin announced that Phozevel Tablets (tenapanor hydrochloride, development code: KHK7791) will be launched in Japan on February 20 for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. 19 February 2024
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