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
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
Pharmaceutical
USA-based rare disease Applied Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of classic galactosemia 28 February 2024
Pharmaceutical
Riding high after a high-profile victory over erstwhile US President Donald Trump, New York Attorney General Letitia James has set her sights on another emotive issue - the safety of certain medicines given to children. 28 February 2024
Pharmaceutical
Indian drugmaker Cipla Limited says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India. 28 February 2024
Pharmaceutical
CNS specialist Minerva Neurosciences lost 59% of its stock market value on Tuesday. 28 February 2024
Pharmaceutical
Belgium’s largest drugmaker UCB today reported earnings results for the full year ended December 31, 2023 with a downturn on sales and earnings, but demonstrating significant achievements and sending its shares up 3.5% to 100.50 euros. 28 February 2024
Pharmaceutical
Shares of biotech FibroGen leapt 14.6% to $2.12 by close of trading Tuesday, after it announced a deal with UK pharma major AstraZeneca for roxadustat would be terminated. 28 February 2024
Pharmaceutical
French ophthalmology company Nicox has announced it will replace its chief executive, Andreas Segerros, with current chief business officer Gavin Spencer. 28 February 2024
Pharmaceutical
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Pharmaceutical
Antiviral specialist Gilead Sciences has announced a new approval from the US Food and Drug Administration, for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 27 February 2024
Pharmaceutical
USA-based Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing treatments for hair loss, has closed a $16.75 million Series A financing. 27 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the marketing application for Exblifep (cefepime/enmetazobactam), submitted by Franco-German firm Allecra Therapeutics. 27 February 2024
Pharmaceutical
When James Burt, the chief executive of lifecycle management healthcare company Pharmanovia, looks back at the mood in the pharma industry in 2023, he is happy to say that he is already experiencing a greater sense of optimism in 2024. 27 February 2024
Pharmaceutical
Japanese drugmaker Shionogi says it has submitted a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan. 27 February 2024
Pharmaceutical
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
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