Regeneron Gets Accelerated FDA OK of Lynozyfic for Blood Cancer Treatment
Regeneron on Wednesday said the FDA green light covers Lynozyfic in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Regeneron Pharmaceuticals (REGN) and Sanofi Announce Approval of Dupixent® By US FDA
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the 10 Best Value Stocks to Buy According to Billionaires. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi announced that the US FDA approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). The approval for bullous pemphigoid brings a novel treatment approach to patients and their caregivers. Also, this approval extends the ability of Dupixent to transform treatment paradigms for people who live with a variety of diseases with underlying type 2 inflammation, from common conditions such as asthma and atopic dermatitis, to rarer ones, including eosinophilic esophagitis and prurigo nodularis, and now including bullous pemphigoid. A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality. Dupixent demonstrated the potential to improve the most challenging effects of bullous pemphigoid, while, at the same time, supporting some patients in achieving sustained disease remission as well as decreased oral corticosteroid use. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) highlighted that the approval also reinforced the demonstrated safety profile of Dupixent in a broad age range of patients, from infants to elderly people, and throughout dermatological, respiratory, and gastrointestinal diseases. The FDA approval was on the basis of data from the pivotal ADEPT Phase 2/3 trial, which evaluated the efficacy and safety of Dupixent as compared to placebo in adults with moderate-to-severe BP. While we acknowledge the potential of REGN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than REGN and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now Disclosure: None. Insider Monkey focuses on uncovering the best investment ideas of hedge funds and insiders. Please subscribe to our free daily e-newsletter to get the latest investment ideas from hedge funds' investor letters by entering your email address below. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CNET
6 hours ago
- CNET
23andMe's Data Breach Settlement Could Net You Free Money: Here's How
Hackers used a credential stuffing attack to gain access to 23andMe accounts in October 2023. Getty Images/Viva Tung/CNET Ever used 23andMe? If you have, you might be able to get paid as part of the company's ongoing class-action settlement, but you'll have to move quickly, since it closes in less than two weeks. It's been a tough few years for the once-popular ancestry-tracking service, which was struck by a prolonged data breach that allowed hackers to gain personal data for about half of the company's 14 million customers in 2023. The company has struggled ever since then, and filed for bankruptcy in March 2025. It is now being acquired by TTAM Research Institute, a nonprofit led by 23andMe co-founder Anne Wojcicki, which outbid Regeneron Pharmaceuticals. The San Francisco-based company, which allows people to submit genetic materials and get a snapshot of their ancestry, announced in October 2023 that hackers had accessed customer information in a data breach. A January 2024 lawsuit accused the company of not doing enough to protect its customers and not notifying certain customers with Chinese or Ashkenazi Jewish ancestry that their data had been targeted specifically. It later settled the lawsuit for $30 million. "We have executed a settlement agreement for an aggregate cash payment of $30 million to settle all US claims regarding the 2023 credential stuffing security incident," a 23andMe spokesman told CNET. "We continue to believe this settlement is in the best interest of 23andMe customers, and we look forward to finalizing the agreement." A few months after that decision, there's now an official method available to make a claim and potentially get paid by 23andMe, in some cases as much as $10,000. Keep reading to get all the details you need, and for more, find out why T-Mobile settlement checks have been delayed and discover whether you can claim a piece of Apple's Siri privacy settlement. How many people did the 23andMe data breach hit? The settlement could cover roughly 6.9 million 23andMe customers whose data was targeted. To qualify, 23andMe customers must also have been US residents as of Aug. 11, 2023. That 6.9 million number includes around 5.5 million customers of 23andMe's DNA Relatives profiles, which lets people find and connect with genetic relatives. The other 1.4 million people affected by the breach used another service known as Family Tree, which predicts a family tree based on the DNA users share with relatives, 23andMe said. How much money could I get from the settlement? At the top end, 23andMe has said it would pay out up to $10,000 with an "Extraordinary Claim" to each customer who can verify that they suffered hardships as a direct result of their information being stolen in the data breach that resulted in unreimbursed costs. This includes costs from "identity fraud or falsified tax returns," acquiring physical security systems, or receiving mental health treatment. Residents of Alaska, California, Illinois and Oregon who were affected by the data breach can also apply for a payment as part of the proposed settlement, since those states have genetic privacy laws with damages provisions. The payments for these individuals are expected to be around $100, depending on how many people file for them, a settlement document said. Also, a smaller subset of affected users whose personal health information was impacted by the breach will be able to apply for a payment of $100. Infographic: Gianmarco Chumbe/CNET. Photo:Will the 23andMe settlement include anything else? Beyond those payments, 23andMe will also offer impacted users three years of a security monitoring service called Privacy Shield, which filings described as providing "substantial web and dark web monitoring." How can I file a claim for the 23andMe settlement? To file a claim electronically, you can use this official online portal from the Kroll Restructuring Administration. An additional online form is available if you would like proof of your claim sent to you. Potential claimants can also download and print out hard copies of the claim form and proof of claim form if they wish to submit them by mail. If you plan to use this method, send your forms to one of the addresses listed on the claims website. The deadline to make a claim is July 14. For more, you can read about how class action lawsuits work.
Los Angeles Times
19 hours ago
- Los Angeles Times
Here's how to get GLP-1 drugs covered by employer health insurance
While the new anti-obesity medications known as GLP-1s are only one tool to combat obesity and cardiometabolic disease, they have changed the medical landscape and are clinically important in treating these diseases. Yet most Americans who have health insurance cannot get coverage for them. For some, the only option has been to resort to compounded drugs for which the Food and Drug Administration has not assured the safety, and for which the main pharmaceutical ingredient is made in Chinese chemical factories without the quality standards of FDA-approved branded drugs. Even that inferior option is going away, as the FDA has declared that the name-brand drugs are no longer in short supply and so the off-brand drugs are no longer allowed. President Trump recently called out 'the fat shot' when he told pharmaceutical companies to offer the United States the same pricing they offer other peer nations. He related a story of a friend in London who told him the price of GLP-1s there is about one-tenth of what it would cost in the U.S. The average listed price in the U.S. is more than $1,000 a month. In England, it is about $150. There is not yet legislative authority to require pharmaceutical companies to sell prescription drugs in the United States at lower prices, but there is a straightforward way that these medications can become affordable to many in the United States. Most employee health insurance coverage is through employer-sponsored plans, in which the budget is based on premiums contributed by both the employer and employee. Few plans provide coverage for any weight loss treatment, but if they did, it would have to fit in that budget — which would probably necessitate raising premiums. Toxic fat is the cause of many cardiometabolic conditions, and GLP-1 drugs can help people reclaim their health. Improving access and affordability could be transformative for public health, given that about 88% of Americans are metabolically unhealthy. Increasingly, employees are telling their employers that they want access to these medications, and many employers would like to offer plans that cover them. The brand-name manufacturers themselves provide a clue to how this could be possible. They offer their drugs directly to patients for around $500 a month. The sticking points? People whose employee-sponsored health insurance would cover even part of the cost of weight loss drugs are not eligible for that reduced price. Also, at $500 a month, even the discounted direct-to-consumer price still makes the drugs unaffordable to many. Drug pricing in the United States is not transparent, and many entities get a share of the dollars that the health plans have budgeted. Simplifying the system with the GLP-1 drugs could make these drugs more accessible. Today, a drug bought from the drug company at $1,000 can include around a $300 rebate negotiated by a pharmacy benefit manager (working on behalf of the employer-sponsored health plan) and is often accompanied by a $150 manufacturer's discount coupon. The resulting price is similar to the around $500 price that drug companies offer directly to patients who don't have coverage for these drugs. If we eliminate the rebates and coupons, so that manufacturers only charge employer-sponsored health plans the same $500 price they charge consumers directly, and then allow employers to contribute part of the cost (say $300 a month), we can get the out-of-pocket costs for employees close to the price at which these drugs are sold in other countries. It would be a rebate-free, coupon-free system with reasonable cost sharing by the employer. The only reason that system of rebates even came to exist was to create enticements so certain manufacturers could persuade pharmacy benefit managers and employee-sponsored health plans to favor their drug over others'. But in this case, where only two main drugs exist and both have publicly available clinical trial data that physicians can use to make informed prescribing decisions, rebates aren't needed. In reality, recent agreements between pharmacy benefit managers and drug manufacturers have prioritized financial interests over clinical appropriateness, determining drug preference based on what benefits the companies, not what's best for the patient. Getting the price of the drugs to an affordable level would significantly remove one of the most despised aspects of the healthcare system — prior approval authorization. Doctors' offices are expending resources to get around barriers erected to limit the use of healthcare plan dollars on expensive medications for those the insurance plan and its managers determine do not need the drug, even when the doctors believe they do. GLP-1s are highly effective for most people, but they also have some serious risks. We should leave it to doctors to make shared decisions with their patients about whether the risks outweigh the benefits. To further create incentives for the pharmaceutical companies to reduce their prices and for employers to share in the cost of these drugs, the Trump administration should agree, as the Biden administration did, to cover them under Medicare. (Trump reversed that effort this year, barring Medicare and Medicaid from using them to treat the disease of obesity.) This plan to simplify payments and expand access would not make all drugs affordable in the United States, but increasing accessibility to GLP-1s can get us on the road to eliminating the significant problem of cardiometabolic disease and improving our health. David A. Kessler, a former commissioner of the Food and Drug Administration, is the author of 'Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight.'
