Diabetes
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Pharmaceutical
Bayer today announced positive results from the much anticipated Phase III FIDELIO-DKD study, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint. 9 July 2020
Biosimilars
French pharma major Sanofi announced on Friday that its Insulin aspart Sanofi (insulin aspart 100 Units/mL) has received European Union marketing authorization, and will provide another treatment option for adults, adolescents and children aged one year and older who have diabetes. 6 July 2020
Pharmaceutical
The European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include renal outcome data from the CREDENCE trial. 3 July 2020
Generics
Chinese inventory costs for Indian drug companies have soared by 10% compared to the pre-COVID-19 days. Indian companies are dependent on China for all the key ingredients made using the fermentation process, where China has achieved global dominance and capacities 1 July 2020
Pharmaceutical
Indian drugmaker Cipla’s closed up 1.4% at 643.95 rupees today, after it announce a partnership with Germany’s Boehringer Ingelheim to co-market three new oral anti-diabetics drugs: Oboravo (empagliflozin), Oboravo Met (empagliflozin+metformin) and Tiptengio (empagliflozin+linagliptin). 29 June 2020
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Rybelsus (oral semaglutide), the first and only oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a tablet, for the treatment of adults with type 2 diabetes. 29 June 2020
Pharmaceutical
USA-based Evoke Pharma says that the US Food and Drug Administration has approved the New Drug Application (NDA) for Gimoti (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. 22 June 2020
Generics
Even as China settles down post COVID-19, the Indian pharmaceutical industry is bracing itself for a reduction in profit margins in the short term, given the expected rise in the prices of active pharmaceutical ingredients (API) and key starting materials (KSM). Aiming to reduce import dependency and to attain self-reliance and drug security, the Indian government has decided to provide incentives to the pharmaceutical industry, reports The Pharma Letter’s India correspondent. 17 June 2020
Pharmaceutical
Global drugmakers operating in Russia have called on the national government to lift the existing “third excess,” norm - the rule, limiting the participation of foreign drugmakers in state tenders in Russia. 16 June 2020
Pharmaceutical
The US Food and Drug Administration has approved Lyumjev (insulin lispro-aabc) injection, 100 units/mL and 200 units/mL, a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. 16 June 2020
Pharmaceutical
Danish diabetes leader Novo Nordisk has released positive data from a post-hoc responder analysis of the PIONEER 1–5 and 8 trials of Rybelsus (semaglutide). 16 June 2020
Pharmaceutical
Getting shed of another batch of non-core products, Japan’s largest drugmaker Takeda Pharmaceutical has entered into an agreement to divest a portfolio of select over-the-counter (OTC) and prescription pharmaceutical products sold exclusively in Asia Pacific to South Korea-based Celltrion. 12 June 2020
Pharmaceutical
Phase IIIa data from the STEP 1 study show treatment with subcutaneous (SC) semaglutide at 2.4mg achieved a weight loss of 16.9%, compared to 2.4% with placebo, after 68 weeks. 5 June 2020
Pharmaceutical
A new trial to be conducted in collaboration with the Duke Clinical Research Institute (DCRI), dubbed EMPACT-MI, will test Jardiance (empagliflozin) as an option to treat and prevent heart attack for people with and without diabetes. 27 May 2020
Biotechnology
A weight management trial testing a 2.4 mg subcutaneous (SC) formulation of Novo Nordisk’s semaglutide has met its primary endpoint, raising the prospect of new market opportunities for the Danish firm. 14 May 2020
Biotechnology
Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations for Denmark’s biggest drugmaker, Novo Nordisk. 6 May 2020
Pharmaceutical
Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). 6 May 2020
Pharmaceutical
Recommendations for marketing authorizations for four novel drugs and four biosimilars or hybrid medicines following the April 28-30 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 1 May 2020
Generics
India-based Natco Pharma has recently launched a generic version of AstraZeneca’s (LSE: AZN) patented anti-diabetes drug Forxiga (dapagliflozin). 28 April 2020
Pharmaceutical
Sanofi said it has shown resilience and maintained full business continuity worldwide including its global industrial network, as the French pharma major posted first-quarter 2020 financial results this morning. 24 April 2020
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
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