Ireland-headquartered drugmaker Shire (LSE: SHP) has agreed to sell its Dermagraft (human fibroblast-derived dermal substitute) assets to US-based regenerative medicine company Organogenesis citing poor prospects for the product. 17 January 2014
Denmark’s Zealand Pharma says it has achieved a milestone under its collaboration with French drug major Sanofi covering Lyxumia (lixisenatide) and any combination product including lixisenatide. 16 January 2014
Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish drug major’s AstraZeneca’s dapagliflozin, (proposed US trade name Farxiga), to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. 9 January 2014
US clinical-stage biotech firm DiaVacs has granted orphan drug designation for its type 1 diabetes mellitus (T1DM) therapy DV-0100 from the Office of Orphan Products Development of the Food and Drug Administration. 6 January 2014
Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes, due to concerns about liver safety. 27 December 2013
Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug Administration and the European Medicines Agency for a 3mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with co-morbidities. 22 December 2013
Confirming recent runors, Anglo-Swedish drug major AstraZeneca revealed this morning that it will acquire the entirety of Bristol-Myers Squibb’s interests in the companies’ diabetes alliance for an initial consideration of $2.7 billion on completion and up to $1.4 billion in regulatory, launch and sales-related payments. 19 December 2013
As the third largest human health disease following neoplastic disease, cardiovascular and cerebrovascular diseases, the number of diabetic patients around the world has continued growing from 246 million in 2007 to 382 million in 2013 at a compound annual growth rate of 7.6%. 17 December 2013
US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug Administration regarding its New Drug Application for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes requesting additional information. 16 December 2013
Secrets of how Bristol-Myers Squibb and AstraZeneca arranged a behind-the-scenes deal to buy Amylin were revealed at the Genesis 2013 conference in London on Thursday. 16 December 2013
Drug majors Bristol-Myers Squibb and AstraZeneca have reportedly decided to stop marketing their diabetes drug Forxiga (dapagliflozin) in Germany, having failed to reach agreement on pricing of the drug with the country’s regulatory authorities. 14 December 2013
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 13 to one that the benefits of dapagliflozin use outweigh identified risks and support marketing of the drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 13 December 2013
Demographics favor the continued strong growth in the diabetes care market, and independent investment research firm Morningstar analysts also expect diagnosis and treatment rates to climb, particularly in emerging markets, where access to care is improving. 10 December 2013
Danish insulin giant Novo Nordisk revealed this morning that the Danish Financial Supervisory Authority today reported the company to the police for violating its obligation under Section 27 (1) of the Danish Securities Trading Act to disclose inside information as soon as possible. 10 December 2013
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) concluded that no added benefit could be derived on the basis of the dossier submitted by Anglo-Swedish drug major AstraZeneca and US partner Bristol-Myers Squibb for their type 2 diabetes drug Onglyza (saxagliptin). 5 December 2013
Results of a 24-week Phase IIIb clinical study showed that French drug major Sanofi’s diabetes drug Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered either before breakfast or the main meal of the day. These results indicate that lixisenatide can effectively lower blood sugar at either time of administration. 5 December 2013
Danish insulin giant Novo Nordisk has presented positive new Phase III data from the investigational therapy IDegLira (insulin degludec [Tresiba]/liraglutide injection [Victoza]) at the World Diabetes Congress of the International Diabetes Federation. 3 December 2013
French drug major Sanofi revealed encouraging full results from the EDITION II study, showing that its investigational new insulin U300 demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with the company’s own drug Lantus. 3 December 2013
Denmark-based global insulin giant Novo Nordisk this morning set out its ambition to further expand its position in the diabetes care market through the continuous discovery, development and marketing of new, improved insulins and GLP-1 analogues as well as combinations of these. 3 December 2013
A multinational survey of more than 10,000 people with type 2 diabetes has been launched by German family-owned drug major Boehringer Ingelheim and US drug major Eli Lilly (NYSE: LLY). 2 December 2013
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
The past year has been a very busy one for privately-held Dewpoint Therapeutics, a Boston firm founded in 2018 that focuses on the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. 7 January 2025
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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