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
Pharmaceutical
The US Food and Drug Administration has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. 26 August 2017
Pharmaceutical
Certain batches of the NovoPen Echo and NovoPen 5 are being recalled by the manufacturer, Danish diabetes care giant Novo Nordisk, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced. 25 August 2017
Generics
Netherlands-based Mylan has reached an agreement with the US Department of Justice finalizing the previously announced Medicaid drug rebate settlement of $465 million. 17 August 2017
Pharmaceutical
Shares in diabetes giant Novo Nordisk are up nearly 3% in Copenhagen this morning, on the news of positive data from the Phase III SUSTAIN 7 trial. 17 August 2017
Biotechnology
US biotech firm Lexicon Pharmaceuticals today released additional positive data from the pivotal Phase III inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. 15 August 2017
Pharmaceutical
Danish diabetes giant Novo Nordisk has announced two changes to its executive team. 15 August 2017
Biosimilars
French drugmaker Sanofi has announced that it has launched a new patent infringement suit against US pharma giant Merck & Co in the USA. 9 August 2017
Pharmaceutical
For the second quarter in a row, the results of Danish diabetes giant Novo Nordisk have sent the company’s share price soaring. 9 August 2017
article
Boehringer Ingelheim has delivered positive results for the first half of 2017. Net sales increased by 24% to 9.2 billion euros ($10.86 billion) on the same period in the previous year after adjustment for currency effects (+27% in euro terms). 2 August 2017
Biotechnology
Texan biotech firm Lexicon Pharmaceuticals says it has exercised its option under its collaboration and license agreement with French pharma major Sanofi to co-promote sotagliflozin in the USA. 2 August 2017
Pharmaceutical
The European Commission has approved an update to the Victoza (liraglutide) label in the European Union that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment. 28 July 2017
Biosimilars
The US Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin in a pre-filled dosing device. 21 July 2017
Pharmaceutical
Consumers and health professionals are advised that Danish diabetes care giant Novo Nordisk, in consultation with Australia’s Therapeutic Goods Administration (TGA), is recalling six batches of NovoPen Echo insulin cartridge holders after detecting that there is a risk that they may crack or break if exposed to chemicals in certain cleaning agents. 11 July 2017
Pharmaceutical
American diabetes startup Diasome Pharmaceuticals has received up to $30 million in funding from a group of four investors, led by British life science venture capitalists Medicxi. 6 July 2017
Pharmaceutical
Japanese drug majors Mitsubishi Tanabe Pharma and Daiichi Sankyo have been cleared to start selling Canalia, a combination therapy for type 2 diabetes, in Japan. 3 July 2017
Pharmaceutical
Novo Nordisk on Friday announced the headline results from a 52-week double-blind Phase II clinical trial with once-daily subcutaneous semaglutide investigating safety and potential for inducing and maintaining weight loss in people with obesity. 25 June 2017
Pharmaceutical
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label for Victoza (liraglutide). 21 June 2017
Pharmaceutical
While EULAR, the big rheumatology conference taking place in Madrid, Spain, from last Thursday through Saturday, generated a great deal of data, a lot focussing on the biosimilars that are coming to this huge market sector (check it out on the TPL’s website at www.thepharmaletter.com) under conference roundup, there was an array of other news hitting the headlines. This included Australian firm pSivida’ Durasert, Regeneron regarding a patent battle with Amgen, a setback for Merck & Co’s Keytruda, Lexicon Pharma and Chi-Med. 18 June 2017
Pharmaceutical
A US Food and Drug Administration (FDA) advisory committee will next week discuss whether Victoza, the Novo Nordisk type 2 diabetes drug can have cardiovascular safety added to its label. 16 June 2017
Pharmaceutical
Results from the landmark CANVAS Program showed Invokana (canagliflozin) significantly reduced the combined risk of cardiovascular (CV) death, myocardial infarction (MI), and nonfatal stroke, versus placebo in patients with type 2 diabetes mellitus (T2DM) at risk for or with a history of CV disease. 14 June 2017
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