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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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Swedish immunology company InDex Pharmaceuticals late yesterday announced that the development of cobitolimod is discontinued. 27 February 2024
Pharmaceutical
California’s Tarsus Pharmaceuticals has announced positive topline results from the Phase IIa CARPO trial. 26 February 2024
Pharmaceutical
Global biopharma R&D productivity rebounded in 2023, according to a new report. 26 February 2024
Pharmaceutical
Dame June Raine, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has today announced that she will be stepping down in the fall following five years in the role. 26 February 2024
Pharmaceutical
Teva Pharmaceutical Industries has formed a partnership with Jiangsu Nhwa Pharmaceutical for the marketing and distribution in China of Teva’s Austedo (deutetrabenazine). 26 February 2024
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA), as part of a coalition of 35 large health stakeholder organizations, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). 26 February 2024
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
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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
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