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
Danish diabetes care giant Novo Nordisk has release top-line results from the COMBINE 3 Phase IIIa trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. 11 January 2024
Pharmaceutical
Privately-held Italian drugmaker Menarini has announced two licensing deals. 11 January 2024
Pharmaceutical
US pharma major AbbVie yesterday revealed it has launched Produodopa (foslevodopa/foscarbidopa) in the European Union (EU). 10 January 2024
Pharmaceutical
Tuesday was a tough day for Grifols, the Spanish producer of blood plasma-based products, as it lost 14% of its stock market value. 10 January 2024
Pharmaceutical
China-based Innovent Biologics has announced that the first Phase III clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity (GLORY-1) met the primary endpoints and all key secondary endpoints. 10 January 2024
Pharmaceutical
The US Food and Drug Administration has published a list of the novel drug that it approved for marketing in 2023. 10 January 2024
Pharmaceutical
The novel type 2 oral polio vaccine (nOPV2), developed by a team including scientists from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has now been quality-assured (prequalified) by the World Health Organization (WHO). 10 January 2024
Pharmaceutical
The US Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Merck & Co’s sotatercept for pulmonary arterial hypertension (PAH). 9 January 2024
Pharmaceutical
Italian family-controlled drugmaker Chiesi Farmaceutici and Cambridge, USA-based Oak Hill Bio have executed a license and development agreement to develop, manufacture, and commercialize OHB-607. 9 January 2024
Pharmaceutical
French pharma major Sanofi has named Brian Foard as head of its Specialty Care Global Business Unit (GBU). 9 January 2024
Pharmaceutical
Sweden-based rare diseases company Calliditas Therapeutics has appointed Maria Törnsén to the position of president North America. 9 January 2024
Pharmaceutical
US biopharma Applied Therapeutics has announced the top-line results of the ARISE-HF Phase III trial of AT-001 (caficrestat) in patients with diabetic cardiomyopathy (DbCM) at high risk of progression to overt heart failure. 8 January 2024
Pharmaceutical
AI company Isomorphic Labs has announced strategic collaborations with two of the world’s leading pharma firms, Eli Lilly and Novartis. 8 January 2024
Pharmaceutical
Japanese pharma major Astellas has provided an update on its decision to stop production of its antibiotic Wilprafen (josamycin) in Russia, as recently reported by The Pharma Letter’s local correspondent. 8 January 2024
Pharmaceutical
German pharmaceutical company Bayer has announced positive top-line results from the Phase III OASIS 1 and 2 studies. 8 January 2024
Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
Pharmaceutical
PwC’s report “Next in pharma 2024: Reinventing for returns,” has now been published. 8 January 2024
Pharmaceutical
A large US study, reported in Nature Medicine, has found no evidence that taking drugs that include diabetes and weight-loss medication semaglutide is tied to an increase in suicidal thoughts. 6 January 2024
Pharmaceutical
Paris, France-based cardiology specialist Corteria Pharmaceuticals has announced the appointment of Dr Mark Pruzanski, as chairman of its board of directors. 6 January 2024
Pharmaceutical
Japanese drugmaker Sosei has appointed a chief operating officer, Toshihiro Maeda, a new role at the company. 5 January 2024
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