Diabetes
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Pharmaceutical
ICER committee sees benefit in oral semaglutide, but superiority over empagliflozin not demonstrated
There were mixed conclusions from the US Institute for Clinical and Economic Review (ICER) newly-released Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of Danish diabetes giant Novo Nordisk’s oral semaglutide, branded Rybelsus, a GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). 10 December 2019
Pharmaceutical
India's domestic drug market bounced back to growth in November. After clocking just 5.1% expansion in October, India's domestic pharma market registered 14.5% year-on-year growth in November. 9 December 2019
Pharmaceutical
The US Food and Drug Administration has issued an update on its investigation into the presence of genotoxic impurities, called nitrosamines, in certain types of drugs. 6 December 2019
Biotechnology
French drugmaker Sanofi is presenting clinical data from its insulin portfolio at the 2019 congress of the International Diabetes Federation, in Busan, South Korea. 4 December 2019
Biotechnology
Texan biopharma Lexicon Pharmaceuticals lost more than 10% of its marke
t value on Monday as the company suffered a new setback in the development of Zynquista (sotagliflozin). 3 December 2019
Pharmaceutical
Multinationals pharmaceutical companies have cut prices significantly for some of the bestselling drugs in China to get covered by China’s newly-updated reimbursement drug list, effective on January 1 ,2020, reports The Pharma Letter’s local correspondent, Wang Fangqing. 29 November 2019
Biosimilars
The US Food and Drug Administration yesterday announced new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products. 26 November 2019
Pharmaceutical
Japanese drugmaker Astellas Pharma has inked a deal with digital health specialist Welldoc to develop and commercialize digital health solutions. 21 November 2019
Pharmaceutical
Home-grown domestic majors control 80% of the Indian pharmaceutical market but, when it comes to top selling drug brands in India, multinational companies tend to take the cake. 20 November 2019
Pharmaceutical
Five additional analyses of the landmark Phase III DAPA-HF trial showed that Farxiga (dapagliflozin) reduced the risk of the primary composite outcome of worsening heart failure (HF), defined as hospitalization or an urgent visit, or death from cardiovascular (CV) causes versus placebo, when added to standard of care. Five additional analyses of the landmark Phase III DAPA-HF trial showed that Farxiga (dapagliflozin) reduced the risk of the primary composite outcome of worsening heart failure (HF), defined as hospitalization or an urgent visit, or death from cardiovascular (CV) causes versus placebo, when added to standard of care. 18 November 2019
Pharmaceutical
For Diabetes Awareness Month, Dr Nicola Davies, in her exclusive column for The Pharma Letter, examines progress being made with a rare form of the condition – monogenic diabetes. 18 November 2019
Pharmaceutical
The European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycemic control in adults with type-2 diabetes (T2D), says Cambridge, UK-based AstraZeneca 15 November 2019
Pharmaceutical
As discussed in last month’s column, The FDA’s take on Medical Innovation, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) strives to support the innovation and development of novel drugs and biological products. 1 15 November 2019
Pharmaceutical
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) advises against marketing authorization of a low dose SGLT2 inhibitor, voting 14 to 2 that the benefits of empagliflozin 2.5mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes, citing a lack of adequate data to support evidence for safety and efficacy. 14 November 2019
Pharmaceutical
Shares of Israeli diabetes specialist Oramed Pharmaceuticals shot up 23.8% to $3.02 in pre-market US trading today, after it announced positive results from the initial cohort of the Phase IIb trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. 12 November 2019
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical today revealed a new agreement to divest a portfolio of select products to Germany’s Stada Arzneimittel for a total value of $660 million. 5 November 2019
Pharmaceutical
Swiss drugmaker Vifor Pharma has agreed to jointly commercialize the new diabetic kidney disease (DKD) indication for Invokana (canagliflozin) in the USA. 4 November 2019
Pharmaceutical
Sanofi has presented new Phase III data on its once-daily long-acting basal analogue Toujeo (gla-300) compared to insulin glargine 100 Units/mL (Gla-100). 4 November 2019
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) on Friday released an Evidence Report assessing the comparative clinical effectiveness and value of Danish diabetes care giant Novo Nordisk’s (NOV: N) newly-approved oral semaglutide, now trade-named Rybelsus, a GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus. 4 November 2019
Pharmaceutical
Danish diabetes care giant Novo Nordisk this morning posted financials for the first nine months of 2019, showing that sales increased by 9% as reported and by 5% at constant exchange rates (CER) to 89.6 billion Danish kroner ($13.29 billion). 1 November 2019
Biotechnology
Ascendis Pharma has granted fellow Denmark-based Novo Nordisk an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Pharmaceutical
Denmark’s Novo Nordisk bucked a down trending market today, rising 1% on promising research results. 1 November 2024
Pharmaceutical
Shares in Merck & Co were more than 2% lower as New York trading entered its latter half on Thursday. The US pharma giant earlier announced its financial results for the third quarter of 2024, along with its latest guidance for the year as a whole. 31 October 2024
Pharmaceutical
US drugmaker Eli Lilly looked set to lose a whopping $730 million in the stock market value on Wednesday, if its lunchtime position was to be maintained. 30 October 2024
Pharmaceutical
Denmark-based Novo Nordisk’s oral semaglutide, marketed as Rybelsus for type 2 diabetes, has not gained much presence in the GLP-1 receptor agonists (GLP-1RAs) market despite its approval in 2019, as its injectable alternatives prove to have higher efficacy and results both in diabetes and obesity patients. 28 October 2024
Pharmaceutical
Sino-America clinical-stage biotech Eccogene announced that it will receive a $60 million payment from AstraZeneca, which is being triggered by successfully achieving milestones related to the development of ECC5004/AZD5004 including the first patient dosed in the Phase IIb program. 24 October 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 23 October 2024
Pharmaceutical
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Pharmaceutical
Gan & Lee Pharmaceuticals as reported that its three investigational drugs - GZR18, GZR4, and GZR101 - achieved positive results in Phase II diabetes trials. 17 October 2024
Pharmaceutical
US pharma major Eli Lilly has announced plans to invest around 1.5 billion renminbi ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
Pharmaceutical
Canada-based biotech Sernova (TSX: SVA) has announced key new appointments to its executive leadership team. 15 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Pharmaceutical
Eli Lilly today announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. 2 October 2024
Biotechnology
USA-based engineered regulatory T cells (Tregs) company GentiBio today announced the appointment of Dr Mark Bach as chief medical officer. 30 September 2024
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