Guaifenesin

Dive Brief:Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsomes top drug at bay in the U.S. until at least 2038.Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesnt, Teva can enter the U.S. market with its copy on Sept. 30, 2038.Dive Insight:Auvelity is one of three drugs Axsome sells and by far the companys top product.Auvelity combines a form of dextromethorphan, which is used as a cough suppressant in drugs like Robitussin, and bupropion, an antidepressant compound that on its own was previously marketed as Wellbutrin.The New York-based biotechnology company also markets Sunosi, a treatment to improve wakefulness in people with narcolepsy or obstructive sleep apnea, and Symbravo, a migraine medicine that U.S. regulators approved last month.The patent settlement with Teva will ensure Auvelity remains a contributor to Axsomes business for years to come, and removes the threat of Teva entering the market earlier. The biotech has a large tranche of Auvelity patents that expire in 2034, which would have been the next line of defense if Teva had succeeded in challenging Axsomes later-dated patentsThe settlement also provides for the termination of all litigation between Axsome and Teva over Auvelity patents that was pending in the New Jersey district court. The companies will submit their agreement to the Federal Trade Commission and the Department of Justice for review.We see this as a material win for Axsome, wrote Myles Minter, an analyst at William Blair, in a client note. Graig Suvannavejh, an analyst at Mizuho Securites, took a similar view, calling the settlement a significant positive for the company.Investors seemed to agree, pushing Axsome shares up by 23% through mid-morning Monday. Part of those gains may be expectations the settlement will put Axsome higher on pharmaceutical companies lists of deal targets.Staying generic entry with this settlement favorably positions the company if there is a potential M&A buyer for Axsome, in our view, wrote Minter.Theres some recent precedent for this line of thinking. Intra-Cellular Therapies patent settlement with Sandoz for its drug Caplyta was one item Johnson & Johnson reviewed before finalizing a $14.6 billion buyout of Intra-Cellular, recently filed regulatory documents show. '

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including a masterclass on menopause, new treatments to cure blindness and the continuing biotech boom in North Carolina. NEW YORK, Dec. 6, 2024 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Dec. 2-6, 2024. Lilly's Zepbound® (tirzepatide) Superior to Wegovy® (semaglutide) in Head-to-Head Trial Showing an Average Weight Loss of 20.2% vs. 13.7% Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound® (tirzepatide) provided a 47% greater relative weight loss compared to Wegovy® (semaglutide). Average Health Insurance Premiums Rise 7% in 2025, Marking Four Consecutive Years of Increases In 2025, private health insurance plans will cost an average of $621 per month, or $7,452 per year - rising 7% from 2024 according to a new report from insurance research site ValuePenguin.com. Residents of 42 states will see higher premiums in 2025 - driven by the rising cost of medical care around the country. MasterClass, Women's Health Advocate Halle Berry and Leading Health Experts Come Together for Stigma-Breaking Class on Menopause Members will learn how to manage symptoms, get practical strategies to thrive and hear inspiring stories of personal experiences—including from Respin founder and longtime menopause advocate Halle Berry. Marking World AIDS Day & Giving Tuesday 2024, (RED) Offers a Galaxy of Gifts That Save Lives This Holiday Season The organization, co-founded by Bono and Bobby Shriver to fight the injustices that enable pandemics to thrive, lights up 'The (RED) Holiday Edit Vol. II.' offering myriad ways to ensure preventable and treatable diseases are preventable and treatable for everyone. From cool tech to fashion and grooming, fragrance to rides on two wheels or four, every action you take with (RED) this holiday season helps save lives. Amgen Announces $1 Billion Manufacturing Expansion in North Carolina The $1 billion facility will incorporate cutting-edge technologies and sustainable practices, aligning with Amgen's commitment to environmental stewardship and manufacturing excellence. In tandem with the existing facility, these investments will create 370 new jobs in the region, supporting a robust biomanufacturing hub. University of Colorado Anschutz Medical Campus-Led Team Receives Up to $46 Million to Develop Innovative Treatment to Cure Blindness "Currently, there has never been a successful whole human eye transplant for the restoration of vision," said principal investigator and surgeon-scientist Kia Washington, MD. "We believe the great advancements over the last two decades in technology, transplantation surgery and regenerative medicine now make restoration of vision possible." Movano Health Receives FDA Clearance for EvieMED Ring "This FDA 510(k) clearance marks a major milestone for the Company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles," said John Mastrototaro, President and CEO of Movano Health. ModifyHealth Raises $13.5M in Funding to Expand Food-as-Medicine Solutions The company announced the funding round led by the Dohmen Company Foundation (DCF) through its Dohmen Impact Investment Fund. With a shared vision to eliminate diet-related disease, Dohmen and ModifyHealth are united in their commitment to scaling innovative food-as-medicine solutions that drive meaningful and sustainable health improvement. Reckitt Opens Its Largest OTC Manufacturing Facility in the U.S. The new state-of-the-art factory in Wilson, North Carolina will produce Mucinex® tablets and liquids to meet increased consumer demand for cold and flu symptom relief in the United States. The Skin of Color Society Foundation Approaches Its 10th Anniversary with Record-Setting Outcomes in Key Supported Programs The Skin of Color Society Foundation (SOCSF) reported record-level growth in key programs that it supports, including an array of innovative research, education, mentorship, and advocacy efforts. The SOCSF was established by the Skin of Color Society (SOCS), an international professional dermatologic organization dedicated to achieving health equity and excellence in patient care through research, education, mentorship and advocacy. Samuel L. Jackson, Kimberly Williams-Paisley and Diedrich Bader Join Alzheimer's Association's First-Ever Fundraising Advertising Campaign "Generation Hope" "Alzheimer's disease has taken my grandfather, grandmother, aunts and uncles. Even my mother. Enough is enough," said Samuel L. Jackson, actor and Alzheimer's Association Celebrity Champion. "I'm proud to join the Alzheimer's Association's 'Generation Hope' campaign because the Association is leading the way in finding a cure and promising new treatments, and providing care and support services for families navigating the disease today." ASTHO Unveils Top Five State Public Health Policy Issues to Watch in 2025 "The prevention of infectious diseases as well as maternal and child health will remain a focus for ASTHO in 2025. Additionally, building up the public health workforce and modernizing our data system will be critical for effective future public health responses," says ASTHO CEO Joseph Kanter, MD, MPH. PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program Under the agreement, PTC will receive an upfront payment of $1.0 billion, up to $1.9 billion in development, regulatory and sales milestones, a profit share in the U.S., and double-digit tiered royalties on ex-U.S. sales. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED