The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Eli Lilly today announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. 2 October 2024
USA-based engineered regulatory T cells (Tregs) company GentiBio today announced the appointment of Dr Mark Bach as chief medical officer. 30 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
Innovent Biologics has announced positive results from a Phase III trial for mazdutide, a dual agonist targeting GLP-1 and glucagon receptor. 12 September 2024
Lexicon Pharmaceuticals has released new data from a Phase III trial showing that its drug sotagliflozin improves certain glucose control parameters in people with type 2 diabetes. 12 September 2024
Eli Lilly has announced positive results from two Phase III trials evaluating its once-weekly insulin efsitora alfa (efsitora) against the daily insulin degludec for adults with type 1 and type 2 diabetes. 11 September 2024
ProKidney announced strategic updates to its Phase III program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease (CKD). 9 September 2024
The short-acting insulin market is poised for significant growth, driven by a rising prevalence of diabetes, technological advancements, and evolving healthcare policies. 6 September 2024
Gene therapy company Genprex (Nasdaq: GNPX) has announced plans to transfer its diabetes program and related assets into a new, wholly-owned subsidiary. 5 September 2024
MHRA has concluded that the available evidence does not establish a causal relationship between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal behavior, suicidal ideation, self-injury and depression. 4 September 2024
Novo Nordisk’s semaglutide—marketed under the names Wegovy and Ozempic—have already shown their potential to treat diabetes, obesity, cardiovascular (CV) conditions and maybe even reduce aging, too. 2 September 2024
Last week’s research news featured a new study from Eli Lilly, showing tirzepatide – the active ingredient of its diabetes drug Mounjaro and obesity treatment Zepbound – can delay the onset of diabetes. On the financial reporting front, Denmark’s Lundbeck released strong first-half results and raised its full year guidance. A new company – Borealis Biosciences – emerged from stealth last week, with funding from Novartis and Versant Ventures. Also of note, US biotech major Regeneron had a setback, when the Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the biologics license application (BLA) for its multiple myeloma candidate linvoseltamab. 25 August 2024
Texas-based Lexicon Pharmaceuticals has announced that, following a strategic review of the company’s commercial and pipeline programs, it will refocus resources across the portfolio and cut jobs. 14 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
The shortage of drugs in Russia is deepening, and is currently being observed in almost 70 regions throughout the country and forcing the local state to consider ways to resume stable supplies to local market, reports The Pharma Letter’s local correspondent. 13 August 2024
US biotechnology company Kallyope, which is focused on identifying and developing therapeutics involving the gut-brain axis, today announced the closing of a $236 million Series D financing co-led by Mubadala Investment Company and The Column Group, along with participation from other new and existing investors. 15 February 2022
Danish diabetes giant Novo Nordisk has reported net sales of 140 billion kroner ($21.3 billion) in 2021, an 11% increase from the year before. 2 February 2022
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
Following the January meeting of the European Medicines Agency’s Medicinal Products for Human Use (CHMP) several drug recommendations were announced. 28 January 2022
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
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
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
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
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
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
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
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
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
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
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
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
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
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
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