Search Results for “Novo Nordisk ” – Page 17 – media

FDA yet to find link between suicidal risk and GLP-1RA use

The US Food and Drug Administration (FDA) released an update on its evaluation of suicidal risk related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The agency did not find a clear link to suicidal risk through a review of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System agency (FAERS) and a meta-analysis of GLP-1 RA clinical trials. Looking at FAERS data, regulators found that reported incidents were often limited in the information provided and did not offer enough evidence to determine a clear relationship with GLP-1 RA use. Furthermore, the large outcome studies and observational studies showed no association between suicidal thoughts or actions and the use of the drug class. Despite this, the agency said that due to the small number of suicidal ideation cases, it would not yet definitively rule out a potential link with GLP-1RA use. The FDA will share its ...
- Source: drugdu
- 160
- January 16, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
- Source: drugdu
- 166
- January 15, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
- Source: drugdu
- 101
- January 12, 2024
AbbVie ends 2023 on a high taking the leading spots as the biggest drug ad spender in December

AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
- Source: drugdu
- 157
- January 10, 2024
Lilly makes website to simplify access to obesity drug Zepbound, plus diabetes and migraine meds

Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
- Source: drugdu
- 160
- January 6, 2024
Playing in the Hot Obesity Market, Carmot Braves Chilly IPO Waters

By Tristan Manalac Pictured: NASDAQ Stock Exchange headquarters Carmot Therapeutics on Friday filed for an initial public offering (IPO), banking on its pipeline of GLP-1 agonists and the multibillion-dollar potential of the obesity market. Carmot did not disclose how many shares of its common stock will be put up for sale or its projected earnings from the planned offering. The company expects to wrap up its IPO before the year closes, after which it will trade on Nasdaq under the proposed ticker CRMO, according to a Nov. 17 SEC filing. The California-based biotech is advancing a pipeline of “life-changing therapeutics for people living with metabolic diseases,” particularly obesity and diabetes, per the SEC filing. One of its most mature candidates is CT-868, a dual agonist of both the GLP-1 and GIP receptors, both of which play crucial roles in the regulation of insulin secretion, appetite and weight. CT-868 is being ...
- Source: drugdu
- 116
- November 22, 2023
AstraZeneca Targets Obesity Market with Potential $2B Deal for Early GLP-1 Candidate

Pictured: AstraZeneca office in Gothenburg, Sweden/iStock, Wirestock AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases. Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales. In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene. “We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon ...
- Source: drugdu
- 144
- November 13, 2023
Meitheal partners with Chinese company for US licencing of insulin biosimilars

Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties ...
- Source: drugdu
- 98
- September 30, 2023
In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency’s release. The companies in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance. Consumers using the illicit products should talk to a doctor, according to the FDA. The companies, for their part, must respond within 15 days of receiving the FDA’s warning letters. CVS appears to be responding quickly. Reuters reports the company said it has stopped the sale of its Pink Eye Relief Eye Drops and that customers who ...
- Source: drugdu
- 104
- September 14, 2023
Weight-loss drug firm becomes Europe’s most valuable

By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
- Source: drugdu
- 229
- September 6, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.