Diabetes
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Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly has recently announced a £279 million ($365.5 million) investment in the UK at the International Investment Summit in London. 19 December 2024
Pharmaceutical
The Egyptian Drug Authority has approved EVA Pharma's insulin glargine injection, marking a significant milestone in its collaboration with US pharma major Eli Lilly. 18 December 2024
Pharmaceutical
The European Commission has approved unconditionally, under the EU Merger Regulation, the proposed acquisition of contract development and manufacture organization (CDMO) Catalent (NYSE: MCTLT) by Denmark’s Novo Holdings. 7 December 2024
Biotechnology
Novavax has agreed to sell its manufacturing plant in the Czech Republic to Novo Nordisk for $200 million. 6 December 2024
Pharmaceutical
Novo Nordisk will reduce the US list prices of two insulin products, Tresiba (insulin degludec) and Fiasp (insulin aspart), by over 70% from 2026. 6 December 2024
Pharmaceutical
Eli Lilly has announced a $3 billion investment to expand its recently acquired manufacturing facility in Wisconsin, USA. 6 December 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk has announced plans to invest 2.9 billion Danish kroner ($410 million) to establish a cutting-edge quality control laboratory in Hillerød, Denmark. 6 December 2024
Biotechnology
Dutch privately held Amarna Therapeutics, which specializes in transformative gene therapies, has entered into a strategic collaboration with Sweden-based NorthX Biologics, a leading biologics manufacturing partner. 4 December 2024
Pharmaceutical
The China-based subsidiary of French pharma major Sanofi revealed it has signed a memorandum of cooperation with Beijing Municipal Bureau of Economy and Information Technology and Beijing Economic and Technological Development Zone today to invest approximately 1 billion euros ($1.05 billion) to establish a new manufacturing base. 3 December 2024
Pharmaceutical
Hua Medicine has announced promising new clinical findings for its glucokinase activator dorzagliatin, presented at the China BioMed Innovation and Investment Conference. 2 December 2024
Pharmaceutical
Australia’s Department of Health and Aged Care has developed a new API (application programming interface) for the efficient distribution of the monthly Pharmaceutical Benefits Scheme (PBS) schedule data. 2 December 2024
Biotechnology
Privately-held UK firm Quell Therapeutics, which positions itself as a pioneer in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, has announced that AstraZeneca has selected a candidate to progress in the type 1 diabetes (T1D) Treg cell therapy program. 18 November 2024
Pharmaceutical
French pharma major Sanofi today announced an investment of 40 million euros ($42.4 million) in its Lyon Gerland bioproduction site, consolidating its role as a strategic platform dedicated to immunology. 15 November 2024
Pharmaceutical
Privately-held Montanan firm Microbion has announced promising findings from its Phase II study of pravibismane, a topical treatment aimed at addressing diabetic foot ulcer infections (DFI). 14 November 2024
Pharmaceutical
While sky high expectations for Eli Lilly’s tirzepatide have not yet been realized, more positive data add to a growing sense that the future could be as bright as imagined. 14 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Biotechnology
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024
Biotechnology
Aurealis Therapeutics, a Swiss-Finnish synthetic biology and China-based Xbiome, an AI-based microbiome drug development company, on Friday announced that they have entered into an exclusive license and collaboration agreement for the clinical development and commercialization of Aurealis investigational diabetic foot ulcer (DFU), other chronic wounds, and inflammatory disease therapy AUP-16 in Greater China. 29 January 2022
Pharmaceutical
Following the January meeting of the European Medicines Agency’s Medicinal Products for Human Use (CHMP) several drug recommendations were announced. 28 January 2022
Biosimilars
The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers. 24 January 2022
Biotechnology
German biotech Evotec has entered into a drug discovery collaboration with Eli Lilly in the field of metabolic diseases with a focus on kidney diseases and diabetes. 18 January 2022
Biotechnology
Novo Seeds, the early stage investment and company creation team of Novo Nordisk’s primary shareholder, has provided a review of its activities in 2021. 12 January 2022
Biotechnology
Boston, USA-based cost-effectiveness watchdog The Institute for Clinical and Economic Review (ICER) has posted a revised “Evidence Report” for Eli Lilly’s tirzepatide. 6 January 2022
Pharmaceutical
A new draft government decree, which was developed by Russia’s Ministry of Industry and Trade, will restrict state purchases of drugs against some serious diseases, among which are HIV, oncology, diabetes and tuberculosis and will lead to their shortage in the Russian market, according to recent statements by representatives of the All-Russian Union of Patients (ARUP), one of Russia’s leading public associations representing interests of patients, reports The Pharma Letter’s local correspondent. 5 January 2022
Biosimilars
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Biosimilars
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
Pharmaceutical
Danish diabetes care giant Novo Nordisk today announced plans to invest more than 17 billion Danish kroner ($2.58 billion) in construction of three new manufacturing facilities as well as expansion of one existing facility at its production site in Kalundborg, Denmark. 13 December 2021
Biotechnology
Mesoblast has provided new analyses from the DREAM-HF Phase III trial showing that the greatest treatment benefit from rexlemestrocel-L is in heart failure and low ejection fraction (HFrEF) patients with diabetes and/or ischemia, who are at high-risk of cardiovascular mortality, heart attacks or strokes. 7 December 2021
Pharmaceutical
Shares of Eris Lifesciences jumped 10% in early trading today after the Indian drugmaker announced its entry into India’s 35–40 billion rupee ($467-$533 million) insulin and GLP1 agonists market through Eris MJ Biopharm Ltd, a special purpose joint venture between Eris and Mumbai-based MJ Biopharm Pvt Ltd 6 December 2021
Generics
The Russian government plans to conduct a pilot project in the domestic pharmaceutical sector that will involve conducting state procurements of drugs manufactured by companies that have a full-cycle production in one of the countries of the Eurasian Economic Union (EAEU). 23 November 2021
Generics
The drastic increase in prices of key active pharmaceutical ingredients (APIs) from 11% to 51% and excipients from 11% to 61% over the past one month has got Indian pharmaceutical industry associations seeking an urgent redressal from the Department of Pharmaceuticals. 22 November 2021
Biosimilars
Typically, in the USA, the list prices of biosimilars at launch have been 15% to 35% lower than that of the corresponding reference products, and the biosimilar market is estimated to lead to savings of $133 billion over the next five years.1,2 22 November 2021
article
Anglo-Swedish pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for Forxiga (dapagliflozin) within its marketing authorization for the treatment of adults with chronic kidney disease (CKD). 5 November 2021
Pharmaceutical
Denmark-based diabetes care giant Novo Nordisk today reported financial results, showing that n the first nine months of 2021 operating profit was 45.01 billion Danish kroner ($5.34 billion), an increase of 5% in kroner terms and up 12% at constant exchange rates (CER). 3 November 2021
Pharmaceutical
French drugmaker Sanofi has beaten forecasts with its third-quarter 2021 earnings figures. 28 October 2021
Generics
German drugmaker Boehringer Ingelheim has obtained two separate interim injunctions against two Indian drugmakers – MSN Laboratories and Dr Reddy’s Laboratories – which launched cheaper, generic versions of their anti-diabetic drug Jardiance (empagliflozin). 28 October 2021
Pharmaceutical
US pharma major Eli Lilly today reported third-quarter 2021 financial results that did not live up to all analysts’ earnings hopes, despite better-than-expected top-line growth, sending the firm’s shares down 1.9% to $240.31 in early trading. 26 October 2021
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