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
Japanese drug major Astellas Pharma has submitted an application in Japan for the additional indication of the selective SGLT2 inhibitor Suglat (ipragliflozin L-proline) for the treatment of type 1 diabetes mellitus in Japan. 11 January 2018
Pharmaceutical
2017 ended with a couple of significant acquisitions stories: Roche’s $1.7 billion deal to buy Ignyta and Mallinckrodt’s $1.2 billion purchase of Sucampo Pharmaceuticals. There was also a flurry of year-end activity from the US Food and Drug Administration, which granted early approval for Aerie Pharmaceuticals’ glaucoma drug Rhopressa, as well as approvals for Exelixis’ cabozantinib and for Merck & Co and Pfizer’s Steglatro. Also attracting attention was Orchard Therapeutics’ fund raising. 31 December 2017
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca saw its shares rise 2.39% to £51.18 on the news today that it has sold a batch of drug rights to the USA’s ANI Pharmaceuticals. 29 December 2017
Pharmaceutical
The US Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets. 26 December 2017
Pharmaceutical
USA-based vTv Therapeutics has entered into a licensing agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly-owned subsidiary of Huadong Medicine, for rights to develop and commercialize vTv’s GLP-1r agonist program in China and other Pacific Rim countries. 21 December 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines for approval at its December 2017 meeting, including two orphan medicines, one of which is also an advanced therapy medicinal product (ATMP), and one biosimilar. 16 December 2017
Generics
The US Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two patents owned by French pharma major Sanofi for the diabetes treatment Lantus (insulin glargine injection) 100 Units/mL, according to Mylan. 15 December 2017
Pharmaceutical
Belgian misfolded protein specialist reMYND and diabetes giant Novo Nordisk (NOV: N) have agreed a licensing deal regarding the former’s ReS39 therapy program. 14 December 2017
Biosimilars
The US Food and Drug Administration has approved Admelog (insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 12 December 2017
Pharmaceutical
Following a positive advisory committee vote in October, the US Food and Drug Administration has now given its formal approval to allow the marketing of Ozempic (semaglutide injection) in the USA. 6 December 2017
Biotechnology
Danish diabetes giant Novo Nordisk has released positive data from clinical programs investigating its next-gen insulin products Tresiba and Xultophy. 5 December 2017
Biotechnology
French pharma major Sanofi is taking aim at Novo Nordisk’s Tresiba (insulin degludec) with two batches of data comparing its newest insulin glargine product Toujeo with Novo’s long-acting insulin option. 5 December 2017
Biotechnology
Mads Krogsgaard Thomsen, Novo Nordisk employee for over a quarter of a century, says he has "been through all the miserable failures as well as the successes of the company, from products that are now off patent to those that don't yet have one." 28 November 2017
Generics
India’s Sun Pharmaceutical Industries says that its US subsidiary is voluntarily recalling two lots of Riomet (metformin hydrochloride oral solution), 500mg/5mL, to the retail level (Class II Recall). 25 November 2017
Pharmaceutical
New data showed that Jardiance (empagliflozin) reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. 15 November 2017
Pharmaceutical
In an Expert View piece, Ulrike Gottwald-Hostalek, senior medical director at Merck KGaA, and Kerstin Brand, director of global medical affairs for diabetes at the German pharma major, consider the case of a therapy that has stood the test of time. 10 November 2017
Pharmaceutical
Indian drugmaker Zydus Healthcare today announced that the Mexico regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval to commercialize Lipaglyn (saroglitazar magnesium) in Mexico. 10 November 2017
Pharmaceutical
French pharma major Sanofi today posted third-quarter 2017 financials, which came in slightly below expectations and showing that total sales rose 4.7% to 9.05 billion euros ($10.54 billion). 2 November 2017
Pharmaceutical
Danish diabetes giant Novo Nordisk saw its shares dip this morning, after the company warned that draft legislation in some US states to make pricing more transparent could impact business in its largest market, and forecast only modest growth for the full years 2017 and 2018. 1 November 2017
Pharmaceutical
French pharma major Sanofi plans to increase the volume of insulin production at its Russian plant operated by CJSC Sanofi-Aventis Vostok more than four-fold. 31 October 2017
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