Diabetes
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Pharmaceutical
Danish diabetes care giant Novo Nordisk has posted a 10% rise in second-quarter of 2019 operating profit to 13.5 billion Danish kroner ($2.03 billion), above an average 13.0 billion kroner forecast in a Reuters poll of analysts. 9 August 2019
Biotechnology
Provention Bio has revealed that the US Food and Drug Administration has granted coveted Breakthrough Therapy designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. 5 August 2019
Pharmaceutical
The AstraZeneca type two diabetes drug Foxiga (dapagliflozin) has had its label updated for the European Union to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial. 5 August 2019
Biotechnology
Immunotherapeutics developer Imcyse today announced the appointment of seasoned biotech expert Thomas Taapken as executive chairman and chairman of the board. 5 August 2019
Pharmaceutical
Ahmedabad-based Zydus Cadila has reported positive top-line results from a Phase III trial of Lipaglyn (saroglitazar) for treating type 2 diabetes. The therapy has been approved in India to treat diabetes-related conditions since 2013. 2 August 2019
Pharmaceutical
Privately-held Boehringer Ingelheim has recorded solid but unspectacular growth in the first half of 2019, a result that shows why the company is prudent to invest in R&D and some significant recent M&A activity. 1 August 2019
Pharmaceutical
Danish diabetes giant Novo Nordisk and UK-based e-therapeutics have extended their research collaboration. 1 August 2019
Pharmaceutical
The US Department of Health and Human Services (HHS) and the country’s Food and Drug Administration (FDA) have announced a plan to import certain prescription drugs in order to lower prices for patients. 31 July 2019
Pharmaceutical
Eli Lilly today posted second-quarter 2019 financial, showing that revenue increased less than 1% to $5.64 billion from $5.59 billion driven by 6% volume growth, and beating Wall Street estimates of $5.6 billion. 30 July 2019
Pharmaceutical
Sanofi has revealed that it was pulling out of a collaboration on the development and commercialize Zynquista (sotagliflozin) for controlling blood sugar levels in type 1 and 2 diabetics. 27 July 2019
Pharmaceutical
The US Food and Drug Administration has approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. 25 July 2019
Biosimilars
The Russian drugmaker Geropharm has officially announced the completion of registration two biosimilars of insulin lispro, particularly those of ultra-short and medium-duration action, according to the company, reports The Pharma Letter’s local correspondent. 17 July 2019
Pharmaceutical
Medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) for Forxiga (dapagliflozin) 5mg with insulin as an option for treating type 1 diabetes in England and Wales. 12 July 2019
Pharmaceutical
Shares of Indian drugmaker Glenmark Pharmaceuticals were up 1.93% at 454.50 rupees this morning after it revealed a non-exclusive sub-licensing agreement with fellow India based Torrent Pharmaceuticals to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, remogliflozin etabonate in India. 11 July 2019
Pharmaceutical
Close on the heels of an alert raised by the US Food and Drug Administration and Health Canada regarding the safety of sodium glucose cotransporter-2 (SGLT-2) inhibitors from Johnson & Johnson (NUSE: JNJ) and Germany-based Boehringer Ingelheim, the Drug Controller General of India (DCGI) has asked drug manufacturers to carry a warning label on all new diabetes drugs, reports The Pharma Letter’s India correspondent. 1 July 2019
Pharmaceutical
Gross domestic product (GDP) in Japan is about $5 trillion, and the country’s pharmaceutical market is one of the largest in the world, with figures from the Ministry of Health, Labour and Welfare (MHLW) indicating a market value of about $95 billion, including non-prescription medications. 28 June 2019
Pharmaceutical
At its June meeting, the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) issued recommendations on three medicines for approval, plus a negative opinion and some indications extensions. 28 June 2019
Pharmaceutical
French drug developer Poxe and Japan’s Sumitomo Dainippon Pharma have announced today positive top-line Phase III data results for the Imeglimin TIMES 3 16-week, double-blind, placebo-controlled, randomized part of the trial for the treatment of type 2 diabetes in Japan. 25 June 2019
Pharmaceutical
French pharma major Sanofi is to cut 466 jobs in France and Germany as part of a sharpening of its R&D focus. 20 June 2019
Biotechnology
Israeli oral drug delivery specialist Oramed Pharmaceuticals has provided an update regarding its ongoing clinical work. 19 June 2019
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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