9 January 2025 Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare.
Swiss pharma giant Roche will resume the supply of its cystic fibrosis drug Pulmozyme (dornase alfa), as the company has found the way for its imports to the Russian market, The Pharma Letter’s local correspondent reports. 29 November 2023
US pharma giant Merck & Co has announced results from STRIDE-3, a Phase III trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. 28 November 2023
India's Draft Patents (Amendment) Rules, 2023, that propose several changes to India's patent regime, have raised significant concerns among public health experts, domestic drug industry chiefs, and civil society organizations. 28 November 2023
US clinical-stage drug developer Ensysce Biosciences and Sweden’s OncoZenge have signed a letter of intent (LoI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge in the USA. 28 November 2023
Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics for its dry eye candidate reproxalap. 28 November 2023
Russia will significantly reduce public procurements of anti-cancer drugs which are not included in the list of vital drugs due to the lack of funds, reports The Pharma Letter’s local correspondent. 28 November 2023
In the USA, the Biden Administration is currently conducting a government-wide review of the use of “march-in” authority under the Bayh-Dole Act. 28 November 2023
US ophthalmic drug developer Ocuphire Pharma has announced the appointment of Joseph (Joe) Schachle into the newly created role of chief operating officer (COO), effective today. 27 November 2023
Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023
Australian dermatology specialist Botanix Pharmaceuticals saw its shares dip 3.2% to A$0.15 this morning, despite announcing receipt of firm commitments for $13.5 million (US) via an institutional placement, with proceeds to support preparation for commercial launch activities for its lead product Sofdra (sofpironium bromide) gel. 27 November 2023
The latest EU Pharma Figures clearly show Belgium has a leading position within the European Union in terms of biopharmaceutical research and development, production and export, says the sector’s trade group pharma.b in a website posting. 27 November 2023
Brazil’s scientific institution for R&D, Fiocruz, through the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) have signed a term of commitment with the National Administration of Laboratories and Institutes of Health Dr Carlos Malbrán (Anlis), aimed at enabling the Argentine institution to produce and supply the yellow fever vaccine in its country. 27 November 2023
A new artificial intelligence (AI)-based model developed by scientists at ETH Zurich could help determine optimal synthesis methods for new active pharmaceutical ingredients (API). 27 November 2023
The European Medicines Agency (EMA) has validated Vertex Pharmaceuticals Type II variation application to the Marketing Authorization for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. 24 November 2023
The glaucoma market across the seven major markets is forecast to increase at a compound annual growth rate (CAGR) of 2.1% from $2.1 billion in 2023 to $2.5 billion in 2033. 10 January 2025
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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