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.
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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
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Pharmaceutical
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
Pharmaceutical
Denmark-based Novo Holdings has entered into a merger agreement to acquire US contract development and manufacturing organization (CDMO) Catalent. 5 February 2024
Pharmaceutical
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
Pharmaceutical
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Pharmaceutical
In the USA, the House of Representatives have voted overwhelmingly in favor of legislation which would restore the ability of drugmakers to fully expense R&D costs incurred within the same tax year. 5 February 2024
Pharmaceutical
The risk of developing and surviving cancer are shaped by where you live, according to a new report on the situation in Europe. 5 February 2024
Pharmaceutical
Japan’s largest drugmaker Takeda Pharma has appointed Dr Phuong Khanh (PK) Morrow as head of the Oncology Therapeutic Area Unit, effective as of January 29. 3 February 2024
Pharmaceutical
The year has started with a bang in pharma M&A. 2 February 2024
Pharmaceutical
Bristol Myers Squibb has reported strong fourth quarter revenues of $11.5 billion and earnings per share (EPS) of $1.70, both higher than many analysts had forecast. 2 February 2024
Pharmaceutical
US drugmaker AbbVie has finally faced its D-Day, having had to deal with declining revenues from its inflammatory diseases drug Humira (adalimumab) due to the first US competition to the mega blockbuster. 2 February 2024
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan, from Novartis and danicopan from AstraZeneca’s rare diseases unit Alexion, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 2 February 2024
Pharmaceutical
Spanish plasma-derived products specialist Grifols says it has reinforced its senior management team with two appointments. 2 February 2024
Pharmaceutical
Positive high-level results from the Japan Phase III trial of acoramidis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed consistency to those in the global BridgeBio Pharma ATTRibute-CM Phase III trial, including survival, cardiac-related hospitalizations and other measures of improved functions and quality of life, at 30 months. 2 February 2024
Pharmaceutical
Yesterday, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), said it is sending initial offers to the participating drug companies of the first 10 prescription drugs selected for negotiation in the first cycle of the Medicare Drug Price Negotiation Program. 2 February 2024
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
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