Search Results for “EC” – Page 381 – media

FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression

By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
- Source: drugdu
- 101
- August 8, 2023
Artificial sweeteners linked to increased body fat, study finds

Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
- Source: drugdu
- 258
- August 7, 2023
Bavarian Nordic locks up $120M BARDA deal to replenish US stock of smallpox, mpox vaccine

After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. The U.S. Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product, the company said in a press release Thursday. The bulk product order represents $96 million of the contract value. That portion will be manufactured and invoiced in 2023 and will “only partly restore the inventory,” Bavarian Nordic said. Bavarian Nordic will also manufacture and supply an additional $3 million worth of liquid-frozen doses in 2023. The rest of the contract will cover “additional services” totaling $21 million, with Bavarian Nordic getting its hands on most of that sum over the next two years. Throughout 2022 and 2023, Bavarian Nordic says it’s manufactured around 5.5 million smallpox/mpox ...
- Source: drugdu
- 207
- August 7, 2023
Novo Nordisk, Eli Lilly face injury lawsuit from user of popular GLP-1 medicines

As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
- Source: drugdu
- 111
- August 7, 2023
GSK files lawsuit against Pfizer over RSV vaccine patent infringement

GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
- Source: drugdu
- 112
- August 7, 2023
Augmedics picks up Surgalign’s digital health assets for $900K

Dive Brief Augmedics, a developer of surgical navigation technologies, will acquire the digital health assets of Surgalign Holdings for $900,000 in cash and assume unspecified liabilities after making a successful bid in a bankruptcy court auction. Surgalign, which is selling its assets under court supervision after filing for Chapter 11 bankruptcy protection, said in a statement on Friday that Xtant Medical Holdings also was selected in a bidding process to acquire its hardware and biologics assets for a cash purchase price of $5 million, along with the assumption of certain liabilities. Augmedics, in a separate statement, said the purchase of Surgalign’s digital health assets and intellectual property will strengthen its augmented reality and AI portfolio. Dive Insight Deerfield, Illinois-based Surgalign filed for bankruptcy in June, a year after the Securities and Exchange Commission charged the company with accounting fraud. The SEC accused Surgalign, formerly RTI Surgical Holdings, of shipping future ...
- Source: drugdu
- 111
- August 4, 2023
Liquid biopsy may be used to identify gene mutations in pediatric arteriovenous malformations

A study presented today at the Society of NeuroInterventional Surgery’s (SNIS) 20th Annual Meeting indicated that it may be possible to use a less invasive technique to identify the gene mutations responsible for some arteriovenous malformations (AVMs) in pediatric patients. AVMs, including vein of Galen malformations, which are usually diagnosed soon after birth, are tangled blood vessels that disrupt blood flow and oxygen circulation, and are most often found in the brain and spinal cord. These vessels can rupture and cause brain hemorrhage, stroke, and brain damage for children and adults. Many complex AVMs in children are caused by a few specific gene mutations, but it’s difficult to find out which mutation is responsible (and, therefore, which treatment to use) without taking a surgical biopsy of the AVM. A surgical biopsy comes with a risk of brain bleeding. As a result, researchers in Australia opted to try using “liquid biopsy”-;taking ...
- Source: drugdu
- 232
- August 4, 2023
Scleroderma Research Foundation launches clinical trial platform to advance treatments

The Scleroderma Research Foundation (SRF) has announced the launch of a new clinical trial platform aimed at advancing treatments for the rare autoimmune disease of the skin and organs. Using a model created over a decade ago to accelerate oncology drug development but not previously used for autoimmune disorders, the CONQUEST platform is designed to identify agents that are ready to progress from phase 2b to phase 3 clinical trials. The initiative, conceived and led by the SRF, will initially focus on interstitial lung disease secondary to scleroderma but will be expanded in the future to address other manifestations of the disease. The first iteration, which is expected to begin in the fourth quarter of this year, will include approximately 400 patients and will test two drugs, including one from Sanofi. The trial will measure forced vital capacity, the total volume of air that can be exhaled during a maximal ...
- Source: drugdu
- 111
- August 4, 2023
Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in the US has awarded a $2m grant to Amygdala Neurosciences to support investigational new drug (IND) application and early development of the aldehyde dehydrogenase (ALDH2) inhibitor for the treatment of alcohol use disorder. According to the 2021 survey by the NIAAA, 29.5 million people aged 12 years and older have experienced alcohol use disorder. Current treatments include behavioural therapy, medication, support groups, and counselling. ANS-858 is an investigational selective and reversible ALDH2 inhibitor, which has been reported to reduce craving and drug-seeking behaviour in preclinical studies. Amygdala CEO Brent Blackburn said in the press release: “This award will enable the development of ANS-858 through pre-clinical evaluation required of an investigational new drug (IND) application to the FDA.” There are multiple drugs currently in development for treating alcohol use disorder. These mainly investigate the use of psychedelic compounds, including Beckly Psytech’s ...
- Source: drugdu
- 97
- August 4, 2023
CS Pharmaceuticals snaps up AxeroVision to shore up ophthalmology portfolio

CS Pharmaceuticals (CSP) has acquired AxeroVision for an undisclosed fee, in a move that will involve a dry eye disease (DED) candidate being transferred over to the UK-based ocular therapeutics company. CSP, which is headquartered in London but develops and commercialises treatments for eye diseases in China, will continue developing AXR-270, a selective glucocorticoid receptor agonist. The drug has been in a phase of developmental dormancy. In August 2021, AxeroVision released positive Phase II results for the candidate in 129 patients with DED with meibomian gland dysfunction (MGD). In a statement announcing the 2021 results, AxeroVision – which spun out from GSK in 2016 – said it was planning to enrol around 800 patients in a Phase III trial comparing the eye cream with a vehicle, and a new drug application/marketed authorisation application filing expected in 2024. However, the company did not issue any further updates on the drug since ...
- Source: drugdu
- 163
- August 4, 2023

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