Sarepta Needs to Show FDA Elevidys Won't Cause More Deaths
The FDA has not seen a convincing explanation as to why Sarepta's gene therapy for Duchenne muscular dystrophy, Elevidys, was tied to two fatal cases of liver failure, the official said, and there may be no single, easily addressable problem the company can quickly fix. A third fatal case of liver failure that occurred during a trial of a separate but similar Sarepta gene therapy is unquestionably relevant information to the safety of Elevidys, said the official, who declined to be identified because the agency's deliberations are private.
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Biologic Therapeutics Market to Hit $794.5 Billion by 2029
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It explores key market trends, challenges, and ESG developments, and examines the emerging technologies shaping the industry. The report also includes a competitive landscape analysis with market share rankings and detailed profiles of leading companies. This report is particularly relevant now due to the growing demand for innovative therapies and the rapid advances in regenerative medicine. Increased investments and intensified research activities are accelerating the development of biologic drugs, while a surge in product approvals is expanding treatment options in many medical fields. These factors are collectively driving significant growth in the biologics market, making timely insights into trends, challenges, and competitive dynamics more critical than ever. The factors driving the market's growth include: Growing Demand for Biologics: Biologics are increasingly favored due to their high efficacy, targeted action, and ability to treat complex diseases like cancer and autoimmune disorders. Patients and healthcare providers are turning to these advanced therapies for better outcomes and fewer side effects. Rising Investments in Biopharmaceuticals: The biopharma sector is seeing a surge in funding from pharmaceutical companies, investors, and governments. These investments support research, clinical trials, and manufacturing infrastructure, accelerating the development and availability of biologic drugs. Product Development Collaborations and Agreements: Collaborations between biotech firms and large pharmaceutical companies are common, enabling shared expertise, reduced costs, and faster product development. Licensing deals and joint ventures also help expand market reach and streamline commercialization. Transition Toward Personalized Medicines: Biologics are central to the shift toward personalized medicine, where treatments are tailored to individual genetic profiles. Advances in genomics and diagnostics enable more precise therapies, reducing trial-and-error in treatment. Aging Population and the Prevalence of Chronic Diseases: An aging global population is leading to a higher incidence of chronic diseases such as diabetes, cancer, and arthritis. Biologics offer effective long-term treatment options for these conditions, making them essential in managing the health needs of older adults. Request a sample copy of the global market for biologic therapeutic drugs report. Report Synopsis Report Metric Details Base year considered 2023 Forecast period considered 2024-2029 Base year market size $456.9 billion Market size forecast $794.5 billion Growth rate CAGR of 9.7% for the forecast period of 2024-2029 Segments covered Type, Source, Application, Region Regions covered North America, Europe, Asia-Pacific, Rest of the World(South America and the Middle East and Africa). Countries covered U.S., Canada, Mexico, U.K., Germany, France, Spain, Italy,China, India, Japan, Australia. Market drivers Growing Demand for Biologics Rising Investments in Biopharmaceuticals Product Development Collaborations andAgreements Transition Toward Personalized Medicines Rising Aging Population and the Growing Prevalenceof Chronic Diseases Interesting facts: The biologic therapeutics market is witnessing higher number of approvals for several new therapies and an increase in biologics approvals yearly. 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Forecasts extend to 2029, highlighting growth in therapeutic applications and technological advances. Purchase a copy of the report direct from BCC Research. For further information on any of these reports or to make a purchase, contact info@ About BCC Research BCC Research market research reports provide objective, unbiased measurement and assessment of market opportunities. Our experienced industry analysts' goal is to help you make informed business decisions free of noise and hype. Contact Us Corporate HQ: 50 Milk St., Ste. 16, Boston, MA 02109, USA Email: info@ Phone: +1 781-489-7301 For media inquiries, email press@ or visit our media page for access to our market research library. Any data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher. 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Deion Sanders says Randy Moss called 'every other day' during cancer treatment
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5 Reasons You Get Random Bruises and When to See a Doctor
Ramming a shin into a coffee table. Bumping a knee into that rod under your desk. Taking a tumble off a bike. These things tend to hurt like [redacted], so you probably won't be surprised when you wind up with a gnarly bruise after. The force of the trauma breaks some blood vessels under the skin, which spill their contents, leading to a splotch that usually appears pink, red, purple, brown, or black, Kathleen Mueller, MD, the system director for integrative medicine and cancer survivorship at Nuvance, a Connecticut-based health system, and member of the board of directors of the American Academy of Family Physicians, tells SELF. But sometimes, the origin of a bruise is less obvious—say, your eye catches a mysterious discolored blotch on a part of your body you don't recall injuring. Getting random bruises can be unsettling, particularly if it's happening more often or they're big and ghastly. But it's pretty common: Research suggests about one in five people may have a genetic tendency for easy bruising that isn't harmful, Sarah Young, MD, a board-certified oncologist and hematologist at Orlando Health Cancer Institute, tells SELF. That said, frequent, unexplained bruising can also be a sign of an underlying health condition interfering with the integrity of your blood or blood vessels. So how can you suss out whether your bruising is NBD or cause for concern? Read on to learn what typically causes random bruises, when it's worth seeing a doctor, and how to keep your personal Halloween horror show at bay. Plenty of everyday lifestyle factors can cause you to get seemingly random bruises or to bruise more easily. You have a change in your life—and you're not as aware of bumps and bangs. The most likely scenario is that you're one of those people who has a natural genetic inclination to bruise more easily, and a life change has caused that tendency to reveal itself, Dr. Young says. For instance, maybe you've switched up your workout routine, or you have a new pet running around your home, or something else has made it easier for you to rack up little bumps and shoves throughout the day. You might not notice these occasional hits, or they may not register as painful, Dr. Mueller says. So the resulting bruises could very well seem like they came out of nowhere. Also worth noting: Some bruises from everyday injuries might not appear in the exact spot where you made contact with that errant door or side table or small child. That's just because of gravity, which can cause the blood spillage to sink, Dr. Mueller says. For instance, if you smack your knee, you could wind up with bruising on your shin; and a bump to the forehead can cause a black eye. Your skin is going through the natural changes of aging. Good ol' 'getting older' strikes again: When your skin starts to thin out in your 40s, 50s, and beyond, you might notice an uptick in bruising. That's because the tiny blood vessels under the skin are less protected and in turn, more exposed to any kind of trauma, Dr. Mueller says. Where little everyday bumps to the arms and legs might not previously have left a mark, you could find that they increasingly cause bruises as you age. You're on a medication that makes you more susceptible to bruising. Certain drugs are more obvious culprits here, like any form of blood thinner. The point of these meds is to prevent certain clots, but that can up your risk of bruising and bleeding, too. These include anticoagulants like Xarelto (rivaroxaban) and Coumadin (warfarin), which block aspects of the clotting process, as well as antiplatelets like aspirin and Plavix (clopidogrel), which keep platelets from gelling together. The former are generally prescribed for daily long-term use in folks who've had a deep vein thrombosis or pulmonary embolism, and the latter, for people who've had a heart attack or stroke. But even taking aspirin often for pain—or, for that matter, any other OTC non-steroidal anti-inflammatory drug (NSAID), like Advil (ibuprofen) or Aleve (naproxen)—could make you more likely to bruise if you're sensitive to its effects on the blood, Dr. Mueller says. A few other medications can also cause bruises to rear their head more frequently, including corticosteroids like prednisone (taken for conditions such as asthma, arthritis, and autoimmune diseases), which can make skin thinner and more fragile, Dr. Young points out. Some antidepressants (including common SSRIs like Prozac and Zoloft) can also raise your risk of bleeding and bruising, she adds, because of their effects on platelets. You've changed your diet or alcohol consumption as of late. Drinking alcohol comes with its fair share of well-known health warnings—it can mess with your cognitive function, wreak havoc on your liver, and up your risk for heart disease and cancer. But in some cases, alcohol use over time can also make you bruise more readily for a few different reasons, Dr. Young says. It can damage your bone marrow, affecting its ability to pump out enough platelets, and long-term, it can also interfere with your liver's production of certain proteins that help prevent bleeding. In the food realm, a dropoff in vitamin C intake could also increase your odds of easy bruising, Dr. Young adds. (Though deficiency is uncommon in developed countries like the US.) This vitamin is critical to the formation of collagen, which doesn't just give your skin bounce; it plumps and strengthens your blood vessels, too. Without enough, they could be more prone to breakage and spillage. Cue: random bruises. In rare cases, an underlying health condition could also prompt out-of-the-blue or frequent bruising. There are a couple categories of conditions that can manifest with random bruising—though they typically surface with other blood-related symptoms, like heavy periods, frequent or lasting nosebleeds, bloody pee or poop, and excess bleeding from minor cuts. One group consists of things you're born with, like various bleeding disorders. These include genetic conditions (such as Von Willibrand Disease, Hemophilia A, and Hemophilia B) wherein your body doesn't make enough of one of the proteins necessary for your blood to clot effectively, Dr. Mueller says. There are also inherited disorders involving too few or defective platelets, which then can't stick together and plug up broken blood vessels. All of these typically show up during childhood, but milder forms might stay hidden into adulthood, Dr. Young points out. The other category of conditions are things you can develop as an adult. In rare scenarios, you could acquire a bleeding disorder—which can happen when your immune system mistakenly attacks certain clotting factors or even platelets. It's also unlikely but possible for an uptick in bruising to signal a form of liver disease, Dr. Mueller notes, given that the liver is responsible for producing many blood-clotting proteins. Though in this case you'd almost certainly have other signs of liver issues (like yellowing of your skin, severe itching, leg swelling, and belly pain). And finally, lots of random bruising can be a sign of a blood cancer like lymphoma or leukemia, Dr. Young says, since these can tamper with the creation and function of platelets. But she'd mainly be worried about that if you were also having other blood-cancer symptoms like the excessive bleeding noted above, as well as unexplained weight loss, fevers, and swollen lymph nodes. When you should see a doctor for spontaneous bruises Rest assured that most bruising isn't cause for concern—even if you don't recall exactly when you might've acquired said bruise. If you feel like you've always bruised easily and you don't have any other symptoms, you're probably in the clear, Dr. Young says. It's also a good sign if your splotches tend to disappear within two weeks, Dr. Mueller says: 'The color usually goes from red [or brown or black, depending on your skin tone] to purple to a little bit bluish to green and finally to yellow,' as your body breaks down the spilled blood and reabsorbs it. There are a few scenarios, however, when random bruises could warrant investigation by your doctor. A big one is if your bruising is occurring on your belly, back, chest, or face, Dr. Young says. These aren't typically areas that you'd bang or bump without noticing it. Spontaneous marks in these regions are more likely to signal something nefarious. Other red flags include a relentless stream of bruises or ones that linger longer than two weeks, Dr. Mueller notes. Also look out for any form of excessive bleeding—like bleeding from your gums when you brush your teeth, prolonged nosebleeds, extra-heavy periods, and blood in your urine or stool—as well as tiny red, purple, or brown dots on your arms or legs called petechiae, which signal little bleeds below the skin, Dr. Young says. And finally, she adds, pay attention to other changes throughout your body, for instance unexplained weight loss, fevers, or swelling. Coupled with random or easy bruising, any new-to-you symptoms or discomfort is plenty of reason to pay your doctor a visit. Your provider will typically be able to suss out the cause of your bruising with a rundown of your medical history (including the medications you're currently taking) and a physical exam, Dr. Mueller says. If they're suspicious of an underlying bleeding disorder or other health condition, they may also do some routine blood work, which includes a count of your platelets. Again, the chances are low that anything turns up abnormal—but if it does, they'll likely refer you to a hematologist, hepatologist (liver doctor), or oncologist, who can work you up further and figure out a treatment plan. There are also a few things you can do in the meantime to reduce your chances of bruising and help the spots heal. The occasional accident—shin to the coffee table, hip to the doorknob—is inevitable, as are the minor hits and jabs of everyday life, so you probably can't prevent bruises entirely. But moving a bit more slowly through the world can help you become more aware of your surroundings and better navigate around obstacles, Dr. Young says. It's also worth clearing up any trip hazards in your space, Dr. Mueller points out, like random clutter on the floor, errant cords, or area rugs that tend to slip and slide. After all, falling is bound to leave you with some sort of bruise…even if you fall in an ideal way to avoid a worse injury. Strength training and balance-boosting workouts (like tai chi and yoga) can also help you better avoid the kinds of trips and tumbles that are sure to leave a mark. And if you feel especially clumsy or uncoordinated? Dr. Mueller suggests physical therapy to help address any issues with your gait and improve your core strength. If you're looking to clear up a bruise you're already rockin', apply a warm compress to it, Dr. Mueller says. The heat can help increase blood flow to the area and clear away some of the byproducts that can crop up as your body reabsorbs the leaked blood. She also recommends very gently rubbing the skin over the bruise (if it isn't incredibly painful) as the physical motion can 'break up some of the leftover blood and facilitate the healthy tissue getting rid of it.' But ultimately, there isn't anything you have to do to heal a bruise beyond practicing patience. Our bodies are designed to resolve the issue with time, Dr. Mueller says: 'They're pretty miraculous that way.' Related: 7 Period Problems You Shouldn't Ignore What to Do When Your Fingernail Gets Bruised (or Falls Off) How to Know If Bleeding During or After Sex Is Normal—and When to Call Your Doctor Get more of SELF's great service journalism delivered right to your inbox. Originally Appeared on Self
