Latest Pharma and Biotech News
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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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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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Pharmaceutical
US clinical-stage pharma company Apnimed has announced that Graham Goodrich has joined the company as chief commercial officer. 23 January 2024
Pharmaceutical
Ionis Pharmaceuticals yesterday announced positive top-line results for the Phase III OASIS-HAE study of donidalorsen in people with hereditary angioedema (HAE), with the news sending the US RNA-targeted drug developer’s shares up more than 5% to $53.58. 23 January 2024
Pharmaceutical
An Expert View from Bob Tilling, vice president, global sales at Kallik. 23 January 2024
Pharmaceutical
Legislation restoring R&D tax deductions has advanced in the US House of Representatives’ Ways & Means Committee. 22 January 2024
Pharmaceutical
French clinical-stage biotech Abivax , which recently completed an around $236 million financing, saw its shares edge up 2.2% to 10.48 euros today, after the company provided an outlook on its 2024 strategic priorities and milestones. 22 January 2024
Pharmaceutical
Last Friday, the US Food and Drug Administration (FDA) approved Balversa (erdafitinib), from healthcare giant Johnson & Johnson's (NYSE: JNJ) subsidiary Janssen. 22 January 2024
Pharmaceutical
The convergence of cutting-edge technologies and breakthroughs in the scientific understanding of cancer have enabled unprecedented opportunities for precision oncology (PO), according to a posting on the European Federation of Pharmaceutical Industries and Associations (EFPIA). 22 January 2024
Pharmaceutical
Medullary thyroid carcinoma (MTC) is a rare neuroendocrine condition that develops in the parafollicular C cells of the thyroid gland.1 It makes up 3%-5% of all thyroid cancers, with a 10-year mortality rate of about 50%.2 20 January 2024
Pharmaceutical
Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 19 January 2024
Pharmaceutical
The urinary tract infection (UTI) treatment market is estimated to be worth $11.24 billion in 2024. 19 January 2024
Pharmaceutical
US healthcare lobbyist Vital Transformation has released a document outlining objections to the expansion of drug pricing policies under the Inflation Reduction Act (IRA). 19 January 2024
Pharmaceutical
Despite the current Bruton tyrosine kinase (BTK) inhibitor market being valued at around $6 billion, sales specifically for chronic lymphocytic leukemia (CLL) are predicted to be nearly $5 billion by 2032 in the seven major markets (USA, France, Germany, Italy, Spain, UK, and Japan). 19 January 2024
Pharmaceutical
USA–based heart disease specialist Windtree Therapeutics has entered into a license agreement with Lee's Pharmaceutical, related to its candidate istaroxime. 18 January 2024
Pharmaceutical
The Medicines Control Authority of Zimbabwe (MCAZ) has signed a Memorandum of Understanding (MoU) with the South African Health Products Regulatory Authority (SAHPRA). 18 January 2024
Pharmaceutical
Following recent approvals in Europe and the USA, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now also granted marketing authorization for Zilbrysq (zilucoplan). 18 January 2024
Pharmaceutical
Stimulants, amphetamines and methylphenidates are the first-line treatment for moderate to severe attention-deficit/hyperactivity disorder (ADHD) across the seven major markets (7MM), notes GlobalData in a forecast on the future of the field. 18 January 2024
Pharmaceutical
Boston, USA-based Ratio Therapeutics has completed a $50 million series B financing, bringing the total raised by the company so far to over $90 million. 18 January 2024
Pharmaceutical
German pharma and crop sciences major Bayer is introducing a new operating model called “Dynamic Shared Ownership” (DSO) worldwide, which will reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. 18 January 2024
Pharmaceutical
Washington University in Missouri, USA, has joined forces with the life sciences investment company Deerfield Management to launch a new R&D venture. 17 January 2024
Pharmaceutical
Global spending and demand for medicines will increase over the next five years to approximately $2.3 trillion by 2028 as more patients get access to new and better medicines, according to a new report from the IQVIA Institute for Human Data Science titled, “The Global Use of Medicines 2024 – Outlook through 2028.” 17 January 2024
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