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
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
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
US pharm major Eli Lilly and German partner Boehringer Ingelheim recently presented results of the Phase III EMPACT-MI trial, which examined patients treated with sodium-glucose co-transporter-2 inhibitor (SGLT-2I) Jardiance (empagliflozin) following a heart attack, at the American College of Cardiology’s (ACC). 19 April 2024
Indian drugmaker Biocon has entered an exclusive licensing and supply agreement with Brazil’s Biomm for the commercialization of its vertically integrated drug product, semaglutide. 18 April 2024
Like its rivals in the GLP-1 space, Eli Lilly continues to explore the potential of Zepbound (tirzepatide) in addressing the broad range of comorbidities linked to obesity. 18 April 2024
At the American College of Cardiology’s 73rd Annual Scientific Session, a study from the Gardy Health system in Atlanta, Georgia, USA, was presented investigating the rates of heart failure hospitalizations (HFH) in heart failure with preserved ejection fraction (HFpEF) patients and diabetes patients on semaglutide. 18 April 2024
German family-owned drugmaker Boehringer Ingelheim today announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned, along with its full-year 2023 financial results. 16 April 2024
A US judge has dismissed a legal claim from pharma major Eli Lilly alleging that an online pharmacy illegally sold an unauthorized compounded version of the company's dual GIP and GLP-1 receptor agonist tirzepatide. 15 April 2024
Affecting one in 19 women, polycystic ovary syndrome (PCOS) remains understudied, with no dedicated treatments. Surprisingly, new diabetes and weight loss drugs may help. 10 April 2024
Cell programming specialist Ginkgo Bioworks today announced the expansion of its strategic partnership with Denmark’s Novo Nordisk under a framework agreement that initially is contemplated to run over five years. 10 April 2024
The Russian drugmaker Geropharm says it plans to launch a generic copy of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide) for the treatment of obesity, reports The Pharma Letter’s local correspondent. 9 April 2024
Increasing interest in targeted therapies is driving demand in the antibody discovery market, finds industry analyst Future Market Insights. 8 April 2024
Two frequent words that people often hear in recent China’s pharma industry comments are “Chu Hai” and “Nei Juan”. The former means “selling overseas,” while the latter means “cut throat competition.” 8 April 2024
Polish biotech company PolTREG has published new data on PD-1+ T-cells, outlining their usefulness as a biomarker for the efficacy of its candidate PTG-007. 4 April 2024
Russian patients with diabetes have been faced with serious difficulties in obtaining ultra-fast insulin aspart Fiasp from Denmark’s Novo Nordisk, reports The Pharma Letter’s local correspondent 3 April 2024
India’s Biocon says that it has received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its complex formulation liraglutide (6mg/ml solution for injection in pre-filled pen). 2 April 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. 22 March 2024
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Just a couple of months after launching its direct-to-consumer pharmacy service, Eli Lilly has announced plans to ramp things up significantly. 14 March 2024