Search Results for “Novo Nordisk ” – Page 14 – media

Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy

The US Food and Drug Administration (FDA) has announced that Lantidra, a cellular therapy for type 1 diabetes (T1D), has become the first treatment of its kind to be approved. Lantidra is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. The approval applies to adults with ‘brittle’ T1D – those unable to reach target glycated haemoglobin (average blood glucose levels) due to repeated severe hypoglycaemic episodes, despite intensive diabetes management and education. T1D accounts for roughly 5%-10% of all diabetes cases. Within this population, an even smaller group, approximately three out of every 1,000 people with T1D, suffer from ‘brittle’ disease. The therapy works by essentially replacing the body’s insulin-producing beta cells in the pancreas. This is achieved through allogeneic islet beta cells that secrete insulin, administered as a single infusion into the hepatic (liver) portal vein. While this is generally sufficient, an additional infusion ...
- Source: drugdu
- 207
- July 3, 2023
Pfizer shelves one oral pill, pivots to another in weight loss drug race

Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
- Source: drugdu
- 108
- June 28, 2023
FDA warns about compounded semaglutide-based drugs

Tyler Patchen The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness. The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective. Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list. Though compounding medications is legal when drug shortages occur, the compounded versions ...
- Source: drugdu
- 121
- June 2, 2023
After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit

Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. As part of the settlement, which was recorded (PDF) in a federal district court in New Jersey, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. The deal comes three months after the company said it would slash price of the type 1 diabetes treatment to the same level to “make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system.” Lilly’s initial move had come a month after President Joe Biden, in his State of the Union address, called on Congress to limit insulin costs for all patients to $35 per month. The Inflation Reduction Act already had limited insulin costs for patients on Medicare at $35 per month. The lawsuit was ...
- Source: drugdu
- 121
- June 1, 2023
ElevateBio Takes Title of Largest 2023 Funding with $401M Series D

By Tristan Manalac Pictured: Hundred dollar bills/courtesy of Nomad_Soul/Adobe Stock On Wednesday, ElevateBio closed a $401 million Series D financing round, making it biotech’s largest private fundraising haul this year. The Massachusetts-based company will use the money to improve further the company’s gene editing, RNA, cell, vector engineering, protein and induced pluripotent stem cell technologies. ElevateBio will funnel these funds into BaseCamp, the company’s end-to-end genetic medicine cGMP manufacturing and process development business. Beyond advancing its platforms, ElevateBio will also use its Series D raise to broaden its geographic reach and increase its manufacturing capacity to satisfy the needs of its industry and academic partners. Wednesday’s funding round follows ElevateBio’s $525 million Series C in May 2021, one of biotech’s largest fundraises of that year. Since then, the company has further solidified its presence in the gene therapy space. In October 2021, ElevateBio bought biotech start-up Life Edit Therapeutics, whose ...
- Source: drugdu
- 114
- May 26, 2023
Eli Lilly to sell low blood sugar drug Baqsimi to Amphastar in deal worth over $1bn

The drug is available in 27 markets, with worldwide sales totalling over $139m in 2022. Eli Lilly will sell its low blood sugar drug Baqsimi to Amphastar Pharmaceuticals in a deal worth over $1bn, the two companies announced. Under the terms of the definitive agreement, Amphastar will pay Lilly $500m at closing and an additional $125m after one year, with Lilly also eligible to receive sales-based milestone payments of up to $450m. Baqsimi is the first and only nasally administered glucagon to treat severe hypoglycaemia – very low blood sugar – in diabetes patients aged four years and above. Classed as a diabetic emergency, severe hypoglycaemia is a complication that can occur in diabetes patients who take insulin and certain anti-diabetic tablets. The condition is characterised by altered mental or physical functioning, including confusion and disorientation, convulsions, loss of consciousness and coma. Lilly launched Baqsimi ...
- Source: drugdu
- 168
- April 28, 2023
WHO considers adding obesity drugs on its ‘essential medicines’ list

Drugs that combat obesity are under consideration for the first time for the World Health Organization’s “essential medicines list,” used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. It covers the active ingredient liraglutide in Novo Nordisk’s obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions. The panel could reject the request or wait for more evidence. A decision by the WHO to include Saxenda and eventual generics on the list for adults would mark a new approach to global obesity by the health agency. It could also pave the way for a newer, more ...
- Source: drugdu
- 129
- April 6, 2023
maker of Wegovy ‘skinny jab’ is funding NHS weight-loss services

The pharmaceutical company that makes Wegovy slimming jabs is funding the expansion of weight-loss services across England as it seeks to boost sales of its obesity drugs, the Observer can reveal. Novo Nordisk is paying the salaries of staff on NHS obesity teams and financing the launch and redesign of services, including giving £206,000 to a health partnership to transform its treatment of obesity. The Danish firm also has financial links to the co-chair of an NHS England weight management advisory group, and paid her almost £50,000 in lecture, consulting and other fees in just two years. Novo Nordisk’s funding arrangements are under the spotlight after an Observer investigation in March found it had paid £21.7m to UK health organisations and professionals in three years before the approval of its Wegovy injections for NHS use. In some cases, recipients of the funding went on to praise Wegovy or support its approval for use on the NHS without ...
- Source: drugdu
- 163
- April 4, 2023
Sanofi to cut US insulin prices by up to 78% in January 2024

Sanofi has said it will cut the US list price of its most widely prescribed insulin by 78%, following similar moves by Novo Nordisk and Eli Lilly earlier this month. The changes will come into effect in January 2024 and will also include a $35 price cap on the same insulin, Lantus (insulin glargine injection), for those with commercial insurance. Around 8.4 million of the 37 million people in the US with diabetes use insulin, but the rising cost of the lifesaving medicine has been a pressing concern for many patients. Sanofi, Novo Nordisk and Eli Lilly produce over 90% of the US insulin supply and have come under recent fire over the rising costs of their products. In January, California attorney general Rob Bonta filed a lawsuit against the three drugmakers and leading pharmacy benefit managers for allegedly using their market power to overcharge patients for insulin. Other states ...
- Source: drugdu
- 141
- March 21, 2023
Sanofi snaps up Ablynx for 3.9bn euros

Sanofi will launch public offers to acquire all shares, including ADSs, warrants and convertible bonds of Ablynx. News of the deal will no doubt come as a great disappointment to Novo Nordisk, which recently stepped up its efforts to buy Ablynx with a second offer valued at around 2.6 billion euros.
- Source: Currenthollywood
- 643
- January 30, 2018
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