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Pharmaceutical
The US Food and Drug Administration issued two lots of warning letters to pharmaceutical majors yesterday, one relating to manufacturing problems at Eli Lilly's Puerto Rico facility where its Humalog insulin is made, and the other to Switzerland's Novartis and Abbott Laboratories of the USA regarding cardiac side effects when their HIV/AIDS drugs are used in combination. 24 February 2010
Pharmaceutical
A US Senate committee has alleged that UK drugs giant GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) poses increased risk of heart attacks, a conclusion which has been rejected by the company, and also criticizes the nation's drug regulatory body. 22 February 2010
Pharmaceutical
In the not-too-distant future we could see diabetes, the seventh leading cause of death in the USA, treated with a vaccine. Several vaccine candidates are in the pipeline, creating a possible $2.4 billion market for diabetes vaccine products by 2020, according to health care market research publisher Kalorama Information, which recently published a survey of emerging vaccine products titled: What's Next in Vaccines? HIV, Malaria, Rabies, MRSA, and 30 Other Vaccine Targets in the 2010-2020 Pipeline. 22 February 2010
Pharmaceutical
Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events, say researchers in a report published in the prestigious medical journal The Lancet. However, they add, clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change. 19 February 2010
Pharmaceutical
USA-based Regeneron Pharmaceuticals and partner Bayer HealthCare of Germany announced that VEGF Trap-Eye showed positive results in a Phase II study in patients with diabetic macular edema (DME). The primary endpoint of the study, a statistically-significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser therapy, was met. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study. 19 February 2010
Pharmaceutical
Denmark's Novo Nordisk, the world's largest insulin maker, yesterday announced that its diabetes drug Victoza (liraglutide [rDNA origin] injection) is now available in the USA, just three weeks after gaining approval from the Food and Drug Administration (The Pharma Letter January 26). 17 February 2010
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) this morning issued a preliminary recommendation for the use of Danish drugmaker Novo Nordisk's Victoza (liraglutide), a once-daily injection, for the treatment of type-2 diabetes as part of triple therapy regimens in the National Health Service in England and Wales. 15 February 2010
Pharmaceutical
An Anglo-Czech team of scientists has discovered how insulin interacts with cells in the human body. Published in the journal Proceedings of the National Academy of Science (PNAS), the findings could give a major boost to researchers hoping to develop viable treatments to fight type I diabetes. 9 February 2010
Pharmaceutical
Cancer is the top priority for Germany's research-based pharmaceutical companies. In the last few years they have launched several treatments that have prolonged the lives of patients with intestinal, breast and various other forms of cancer. Around a third of research projects are dedicated to the development of new cancer therapies. 8 February 2010
Pharmaceutical
The US Food and Drug Administration yesterday granted marketing authorization for Danish insulin giant Novo Nordisk's Victoza (liraglutide) for the treatment of type 2 diabetes in adults, and also for US firm BioSpecific Technologies' Xiaflex (collagenase clostridium histolyticum) for a debilitating hand condition. 3 February 2010
Generics
The UK subsidiary of global drugs behemoth Pfizer has today launched six generic medicines for its pharmacy and dispensing customers. These drugs have been introduced into Pfizer's Established Products Business Unit portfolio of over 80 off-patent medicines, following agreements between Pfizer and generic medicine manufacturers Aurobindo Pharma and Claris Lifesciences last year, the firm noted. 3 February 2010
Pharmaceutical
Danish drugmaker Novo Nordisk reported full-year 2009 sales of 51.08 billion Danish kroner ($9.53 billion, up 12% and 11% higher in local currencies. Reported operating profit increased 21% to 14.93 billion kroner. Adjusted for the impact from currencies, underlying operating profit rose by more than 15%. Net profit advanced 12% to 10.77 billion kroner and earnings per share (diluted) increased 15% to 17.82 kroner. 2 February 2010
Pharmaceutical
Intense treatment to lower blood sugar in patients with diabetes could prove nearly as harmful as allowing glucose levels to remain high, a study says. British scientists have gauged the risk posed by hypoglycemia - a lack of sugar in the blood - in a major study of diabetics that also points to possible changes in treatment guidelines. 28 January 2010
Pharmaceutical
The US Food and Drug Administration yesterday approved Danish insulin giant Novo Nordisk's Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults, after safety concerns delayed the agency's decision by about 10 months. Last April, a panel of FDA experts were split, voting six to six on whether the agency should clear Victoza in the face of evidence it caused cancerous thyroid tumors in rats and mice. 26 January 2010
Pharmaceutical
Today, Taiho Pharmaceutical, the Japanese licensee of Switzerland-based Helsinn's second generation 5-HT(3) receptor antagonist palonosetron, gained marketing approval in Japan for the prevention of chemotherapy-induced nausea and vomiting (CINV) (including delayed phase) in patients with cancer. 20 January 2010
Pharmaceutical
A new analysis found that the cost of diabetes and pre-diabetes in the USA reached $218 billion in 2007, with the exploding number of cases of type 2 diabetes responsible for the majority of the costs. The National Changing Diabetes Program (NCDP), a program of Denmark-based insulin giant Novo Nordisk, commissioned the analysis, which was funded by the company and is published on-line as a Web First article in Health Affairs. The work was carried out by researchers at The Lewin Group. 14 January 2010
Pharmaceutical
The US Food and Drug Administration yesterday sent warning letters to domestic drugmakers Eli Lilly, Amylin and Cephalon, as well as the US subsidiary of German major Bayer accusing them of making inaccurate or incomplete statements while promoting their drugs. 13 January 2010
Pharmaceutical
US drug developer Reata Pharmaceuticals has entered into a licensing agreement that provides Japan's Kyowa Hakko Kirin with the exclusive rights to develop and commercialize Reata's lead compound, bardoxolone methyl, in Japan and other selected Asian markets. Under the terms of the deal, Reata is eligible to receive up to $272 million in up-front fees and milestone payments, in addition to double-digit royalties. 8 January 2010
Pharmaceutical
US firm Incyte saw its shares rise 5% to $8.92 after announcing it had entered into an exclusive worldwide license and collaboration deal with drug major Eli Lilly for the development and commercialization of its oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis. 22 December 2009
Pharmaceutical
Swiss drug major Roche has announced headline results from the fourth and fifth of eight T-emerge Phase III studies involved taspoglutide, a diabetes drug candidate licensed from France's Ipsen, with both studies meeting their primary endpoints. 18 December 2009
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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