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The Impact of GLP-1 Weight Loss Drugs on Patients, Healthcare Business

Don Tracy, Associate Editor The rise in popularity of GLP-1 weight-loss drugs, such as Ozempic, Wegovy, and Mounjaro, has had a wide-reaching impact across the healthcare industry and beyond. Image Credit: Adobe Stock Images/Dimid The launch of multiple glucagon-like peptide (GLP-1) drugs for weight loss—such as Ozempic, Wegovy, and Mounjaro—is expected to cause a major shakeup in the stock market, as millions of Americans are set to shed hundreds of millions of pounds over the next decade while reshuffling trillions of dollars in the process, according to expert analysis. Not only have these treatments helped patients shed a significant amount of pounds, but they have also shown efficacy treating other conditions as well. A recent drug trial by Novo Nordisk found that semaglutide, the active ingredient in Ozempic and Wegovy, could help people with kidney failure as well. As shares of Novo Nordisk and Mounjaro developer Eli Lilly increase, dialysis ...
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- November 4, 2023
Combination Vaccines Are Coming for Respiratory Diseases

By Kate Goodwin Pictured: A researcher at work in a Novavax laboratory/Novavax, Patrick Siebert Combination vaccines are nothing new for the healthcare industry. Childhood vaccines, as well as a single shot for tetanus, diphtheria and pertussis for adults, have long been combined for ease of administration and increased compliance rates. Now, as vaccines for COVID-19 and, for older people, RSV and pneumococcal disease join the annual flu shot as routine care recommendations for adults, healthcare professionals are increasingly concerned over getting the word out, vaccine fatigue and logistical hurdles. Biopharma companies are betting there will be a market for vaccines that combine protection against two or more diseases in a single jab. Benefit to the Population “The data are pretty unequivocal that when there are combo vaccines available, people generally prefer [them],” said Andrea C. Love, an immunologist and microbiologist and founder of the Unbiased Science Podcast. Love pointed out ...
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- November 4, 2023
Moderna Posts Q3 Loss, Takes $1.3B in Write-Downs on COVID-19 Shots

By Tyler Patchen While Moderna’s total revenue for the third quarter beat Wall Street expectations, the vaccine maker on Thursday posted a loss as demand for its COVID-19 shots declined. Moderna announced that overall sales for the third quarter were $1.8 billion, down from $3.4 billion in the same period of 2022. Net product sales for Moderna were also down 44% from last year due to a “lower sales volume” but partially offset by a higher average selling price the company unveiled. In the third quarter, Moderna said it saw charges of $1.3 billion for “inventory writedowns,” which were related to “excess and obsolete COVID-19 products.” Investors were not pleased as Moderna’s stock price fell over 15% pre-market on Thursday. “Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year’s vaccination rate to be similar to last fall,” Moderna CEO ...
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- November 4, 2023
Alliance for mRNA Medicines launched to accelerate global innovation

A group of 31 biotechnology, biopharma and life sciences companies and educational institutions have launched the first global organisation dedicated to advancing mRNA medicines. The Alliance for mRNA Medicines (AMM), which issued its first announcement at the International mRNA Health Conference in Germany, is now the only scientific and policy organisation singularly focused on global mRNA innovation. It also serves as an advocate for policies before legislative and regulatory bodies in North America, Europe and Asia to support innovation, define regulatory standards and enhance patient access to mRNA medicines. The AMM states that its mission is to “propel the future of mRNA medicine, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists and other key stakeholders”. Founding members of the organisation include BioNTech, CSL, CureVac, Ginkgo Bioworks, Ethris, Johns Hopkins University, Mayo Clinic, Replicate Bioscience and Verve Therapeutics. “This is a pivotal moment ...
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- November 4, 2023
Merck’s Keytruda combination granted FDA approval for biliary tract cancer

Merck & Co – known as MSD outside the US and Canada – has announced that the US Food and Drug Administration (FDA) has approved its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The approval, which represents the sixth gastrointestinal cancer indication for Keytruda-based regimens in the US, means Keytruda can now be used alongside gemcitabine and cisplatin to treat patients with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 20,000 people are diagnosed with the disease each year in the US and about 70% of BTC patients are diagnosed at an advanced stage. The FDA’s approval was supported by results from the late-stage KEYNOTE-966 trial, which demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. The results showed that the Keytruda regimen reduced ...
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- November 4, 2023
Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). The first came Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection. The second came Wednesday when the FDA blessed Voquezna for gastroesophageal reflux disease erosive esophagitis (erosive GERD) and associated heartburn. Two approvals for the same compound in a week is unusual. The FDA originally endorsed Voquezna for H. pylori in May of last year, but then it put Phathom’s launch plans on hold when trace levels of a cancer-causing agent were discovered in commercial batches of the treatment. That initial approval was later revoked. During the impurity-related holdup, the FDA also iced Phathom’s application for approval for erosive GERD. In April, after receiving complete response letters for both applications, Phathom said that it had shown the FDA stability ...
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- November 4, 2023
Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. After traveling a tumultuous road to the June approval, Sarepta reaped $69.1 million from Elevidys’ first quarter on the market. The number was more than enough to beat analysts’ expectations of between $20 million and $24 million. Sarepta stayed mum on exactly how many patients have received an infusion and instead provided revenue as a marker for uptake, CEO Doug Ingram said on Sarepta’s third-quarter earnings call. The drug is priced at $3.2 million per infusion. Also on the call, Sarepta reiterated its confidence that its phase 3 EMBARK study can potentially support a label expansion for Elevidys despite missing its primary endpoint. The company’s discussions with FDA leadership have shown that the agency is open to the idea of a label expansion “if supported by review ...
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- November 4, 2023
FDA warning letter accuses Wavi of selling unapproved neurological device

Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
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- November 3, 2023
$13M NIH grant funds research to rejuvenate immune system in older adults

University of Arizona Health Sciences researchers received a $13.1 million grant from the National Institute on Aging to continue studies aimed at rejuvenating the immune system of older people in order to improve health throughout the lifespan. Older adults are disproportionally affected by infection, cancer and certain types of autoimmune disease. This is influenced by the fact that as a person ages, their body produces fewer T cells and gets less proficient at maintaining them. T cells are a type of white blood cell essential to the immune system and defense against infection. Janko Nikolich, MD, PhD, principal investigator, professor and head of the Department of Immunobiology at the University of Arizona College of Medicine – Tucson, said, “It is clear how much our immune system declines with age when you look at all the previous epidemics and pandemics that have hit us, including COVID-19. Older adults die at a ...
- Source: drugdu
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- November 3, 2023
More Than 60 Groups Ask Senate Leadership To Pass Legislation To Lower Drug Prices

In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space. By MARISSA PLESCIA More than 60 organizations sent a letter Wednesday to Senate Majority Leader Chuck Schumer (D-New York) and Senate Minority Leader Mitch McConnell (R-Kentucky). The letter calls for the passing of legislation that the organizations say would lower drug prices through patent reform and increased competition. The organizations include Patients for Affordable Drugs Now, a nonprofit fighting to lower prescription drug prices, and AARP, a nonprofit focused on Americans aged 50 and older. They call for the Senate leadership to advance the following bills: • S. 142, which would tamp down on pay-for-delay deals. This refers to when brand name drug makers pay potential generic and biosimilar competitors to prevent them from bringing their product to market. • S. 150, ...
- Source: drugdu
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- November 3, 2023

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