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Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges
Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges

Business Upturn

time5 hours ago

  • Business
  • Business Upturn

Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges

Sydney, Australia: As Live Biotherapeutic Products (LBPs) begin to transition from frontier science to clinical reality, Novotech, a leading global CRO and scientific advisory partner has published a new white paper examining the opportunities and challenges shaping this fast-evolving landscape of therapeutic class. This press release features multimedia. View the full release here: LBPs, which harness live microorganisms to restore or modulate human health, are being explored across a growing range of indications, from gastrointestinal and metabolic disorders to CNS and oncology. FDA approvals of Rebyota™ and Vowst™ have validated the category but for most biotech sponsors, the journey remains uncertain. According to Novotech's analysis, over 90% of LBP assets are still in early development stages, and nearly one-third of all trials from 2020 to 2025 have been withdrawn or suspended due to regulatory, manufacturing, or design complexities. Highlights from the report include: A growing pipeline of preclinical and Phase I–II LBP candidates, with notable concentration in Alzheimer's, IBD, diabetes, and NASH. Over 90 industry-sponsored trials launched since 2020, yet 32% have experienced discontinuation. North America and Europe leading in regulatory approvals and manufacturing activity, with rising interest from biotechs in Asia-Pacific. A projected CAGR of 38% for the LBP and microbiome CDMO market through 2030. The global market for LBPs and microbiome contract development and manufacturing organizations (CDMOs) was valued at USD 31.84 million in 2023. With growing investment in players like Vedanta Biosciences and MaaT Pharma, the LBP field is maturing but also becoming more competitive. Success will depend on smart trial design, global regulatory navigation, and efficient feasibility execution. Drawing on deep therapeutic expertise in microbiome-related studies and gastrointestinal, metabolic, and immunologic indications, Novotech supports sponsors from early development through global trial delivery. With operations spanning Asia-Pacific, North America, and Europe, Novotech is uniquely positioned to help biotech and small to mid-size pharma companies translate LBP potential into clinical success. Download the full white paper 'Why Live Biotherapeutics Matter to Emerging Biotech' here. For further information, please visit About Novotech Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase. With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results. For more information or to speak to an expert team member visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash

Stages of Crohn's Disease
Stages of Crohn's Disease

Health Line

time3 days ago

  • Health
  • Health Line

Stages of Crohn's Disease

Key takeaways Crohn's disease symptoms can be mild, moderate, or severe. It's a progressive disease, but its stages are hard to determine because each person's condition progresses differently. The earlier you treat and manage Crohn's, the more likely you are to reduce your chance of developing more severe symptoms. There's no cure for Crohn's disease, but medications and lifestyle changes can help manage the condition. This is why it's crucial to identify the disease when symptoms are still mild. Crohn's disease is a type of inflammatory bowel disease (IBD). It's considered a chronic condition, which means that you'll have it for your entire life. The exact cause of Crohn's is unknown. It most often develops in your late teens or 20s. Crohn's disease is marked by inflammation of the gastrointestinal (GI) tract. The inflammation can appear anywhere in the GI tract, from the mouth to the anus. What are the stages of Crohn's disease? Crohn's is a progressive disease that starts with mild symptoms and gradually gets worse. With mild to moderate Crohn's, you may experience diarrhea or abdominal pain, but you won't experience other symptoms or complications. You're able to move, eat, and drink as normal, and the disease has a minimal impact on your quality of life. In some cases, you won't even require treatment. If you have moderate to severe Crohn's disease, you may experience diarrhea or abdominal pain, as well as additional symptoms and complications, such as fever or anemia. If your Crohn's is severe, you might be in constant pain and discomfort, and you may need to use the bathroom frequently. That said, it's difficult to classify Crohn's disease into stages because people tend to experience ups and downs in symptoms. What progression looks like can be different for each person, and treatment can affect your outlook. How quickly does Crohn's disease progress? Over time, Crohn's can cause damage to the intestines and lead to potential complications such as strictures, fistulas, and abscesses. Stricture means that a portion of the intestine becomes narrower due to scar tissue on its wall. While there's no time frame for how long it would take for such complications to develop, there are risk factors that may speed up progression. These include: being under 30 years old having a history of smoking having ulcers found in a colonoscopy having the long bowel segments affected by the disease having anal inflammation having symptoms that go beyond the intestinal system, such as in the eyes, skin, liver, or joints having a history of bowel resections At diagnosis, 10% of people already have strictures, and an additional 15% to 20% will develop them within the next 10 to 20 years. Five types of Crohn's disease Progression may also depend on the type of Crohn's disease you have. These are: ileocolitis ileitis gastroduodenal Crohn's disease diffuse jejunoileitis Crohn's colitis Crohn's disease progression patterns The patterns by which Crohn's might progress are: Chronic relapsing: With this progression type, you typically experience at least 12 months of remission before experiencing a flare. Common symptoms of a Crohn's disease flare-up may include diarrhea, abdominal pain, weight loss, blood in stool, and fatigue. Remission: Remission means that your symptoms improve or disappear completely. Various studies show most people will relapse within 8 years of diagnosis, with a 43% to 45% remission rate after 10 years. But if you stay in remission for a year, there's an 80% chance remission will continue for the next year. Improved and stable: This is when your condition has progressed to having no symptoms and has remained this way, though signs of the disease might still show up on tests. Chronic refractory: This means you continue to show symptoms without any breaks or remission. About 10% to 15% of people with Crohn's experience a chronic refractory disease course. That said, even different people living with the same Crohn's pattern might progress differently. Genetics, type of treatment, and surgery are also factors that may affect which disease course you follow. The earlier you treat and manage Crohn's, the more likely you are to reduce your chance of developing more severe symptoms. What is the life expectancy of someone with Crohn's disease? There's no cure for Crohn's disease, though many people can live fulfilling lives with long periods of remission. That said, although there's been an increase in life expectancy for people living with inflammatory bowel diseases (IBDs), the life expectancy of Crohn's is still lower compared to those without IBDs for both males and females. When Crohn's causes complications, it can, in rare cases, lead to death. Common causes of death include cancer, heart disease, and infection. What are the early symptoms of Crohn's disease? In Crohn's disease, healthy cells in the GI tract attack themselves, causing inflammation. As a result, you'll likely experience a range of symptoms. Early signs of Crohn's disease include: frequent cramps ongoing abdominal pain frequent diarrhea bloody stools unintentional weight loss As the disease progresses, you may start feeling fatigued and even develop anemia. You may also experience nausea from constant irritation of the GI tract. In addition, you may start experiencing symptoms outside of the GI tract. These symptoms include: eye pain fever joint inflammation and pain red skin rashes and bumps mouth sores Early diagnosis is important to help prevent damage to the intestines. If you experience these symptoms and have a family history of Crohn's, you should ask your doctor for testing. How is Crohn's disease treated and managed? Medications can treat inflammation and stop your body from attacking its own cells. As your symptoms progress, your gastroenterologist may also recommend occasional bowel rest. However, not all doctors agree with this measure. A bowel rest involves a strict diet of only liquids for a few days. The purpose is to let the GI tract heal from inflammation and essentially take a break. To prevent malnutrition, you may need an IV. Talk with your doctor before switching to a liquid diet. Following this, your doctor may follow a special Crohn's diet and take supplements. You also may need to take pain medication. Avoid nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), as these can make Crohn's worse. Instead, ask your doctor if you can safely take acetaminophen (Tylenol). You may need surgery if your symptoms become life threatening. Around 67% to 75% of all people with Crohn's will eventually need surgery, according to the Crohn's & Colitis Foundation. Surgery can't cure the disease, but it may help repair severely damaged tissues and remove blockages.

Can Ulcerative Colitis Be Deadly?
Can Ulcerative Colitis Be Deadly?

Health Line

time4 days ago

  • Health
  • Health Line

Can Ulcerative Colitis Be Deadly?

Key takeaways While ulcerative colitis itself is not fatal, it's a chronic disease that needs to be properly managed to prevent serious health complications. Potentially serious health complications that can result from UC include toxic megacolon, a perforation in your bowel, primary sclerosing cholangitis, colorectal cancer, and heart disease. UC is a chronic condition that, for most people, requires lifelong treatment, and the only way to cure the condition is by having surgery to remove your colon and rectum. Ulcerative colitis (UC) is a lifelong condition that you need to manage. It's not deadly on its own, but it is a serious disease that can cause some dangerous and potentially life threatening complications, especially if you don't get the right treatment. UC is one form of inflammatory bowel disease (IBD). It causes inflammation in the inner lining of your rectum and your large intestine (also known as your colon). The other type of IBD, Crohn's disease, can affect any part of your digestive tract. When you have UC, your immune system mistakenly attacks your intestines, and these attacks lead to inflammation and sores, or ulcers, in your intestines. Treatments are available for UC. Most people with UC have a full life expectancy. However, according to one 2003 Danish study, complications can increase the risk of an early death. Ulcerative colitis complications While UC itself usually isn't fatal, some of its complications can be. Potentially serious health complications that can result from UC include: toxic megacolon a perforation (hole) in your bowel primary sclerosing cholangitis colorectal cancer heart disease Toxic megacolon The most serious possible complication related to UC is toxic megacolon, which is swelling of your colon that can cause it to rupture. This condition affects up to 10% of people with UC. Some studies show that the death rate among people hospitalized with toxic megacolon is around 6.5%. However, the death rate drops to less than 2% in people with IBD who receive an early diagnosis and prompt medical care. Bowel perforation A hole in your bowel is also dangerous. Bacteria from your intestine can get into your abdomen and cause a potentially life threatening infection called peritonitis. Primary sclerosing cholangitis Primary sclerosing cholangitis is another rare but serious complication of UC. It causes swelling and damage around your liver and in your bile ducts, which carry digestive fluid from your liver to your intestines. Scars can form and narrow your bile ducts, and this can eventually cause severe liver damage. In time, you can develop serious infections and liver failure. These conditions can be life threatening. Colorectal cancer According to a 2001 research review, people with UC have up to an 8% chance of developing colorectal cancer within 20 years of their UC diagnosis. In comparison, the review noted that the risk among the larger population was 3% to 6%. More recently, a 2023 review article noted that rates of colorectal cancer among people with UC are decreasing but are still higher than the rates in the larger population. Colorectal cancer can be fatal if it spreads to other parts of your body. Heart conditions According to a 2022 study, UC is associated with a greater risk of heart conditions, including coronary artery disease, heart failure, and atrial fibrillation. And a 2023 study suggests that people with IBD are at a higher risk of death from these types of heart conditions.

‘I thought my life would change': Overcoming an invisible disease to get back into sport
‘I thought my life would change': Overcoming an invisible disease to get back into sport

The Age

time4 days ago

  • Health
  • The Age

‘I thought my life would change': Overcoming an invisible disease to get back into sport

Two years ago, 15-year-old Sienna Warren was diagnosed with severe Crohn's disease. She has also had colitis, or inflammation of the large intestine. The diagnosis has meant months away from school and a slowing down of the active life she led before. 'I still get pretty bad brain fog that interferes with school, and fatigue which interferes with activities I want to do,' Sienna says. 'I love crafts, I love singing, I love dancing, I would love to do drama, but I just can't. And it's hard to do sport in school.' There are two main types of inflammatory bowel disease (IBD): Crohn's disease and colitis. The main symptoms and complications include fatigue, abdominal pain, diarrhoea and vomiting. An estimated 180,000 Australians live with IBD, about 5240 of whom are children and 21,590 are young adults aged 19 to 29. The disease can hinder or prevent people from doing things many of us take for granted, like dating or attending school or work. It can also make it difficult for people, like Sienna, to play sport. According to the latest State of the Nation Report, published by Crohn's & Colitis Australia earlier this year, 21 per cent of adults and 18 per cent of children with IBD had severe problems with, or were unable to participate in, sport. Invisible disease Sienna says IBD is an 'invisible disease', and that more education is needed to help the public better understand its impact. 'We're looking at disabilities in school, but all the disabilities they're looking at are visible disabilities and visible impairments. It's not enough,' she says.

Bet you didn't know there's a link between the mouth and digestive problems
Bet you didn't know there's a link between the mouth and digestive problems

The Star

time4 days ago

  • Health
  • The Star

Bet you didn't know there's a link between the mouth and digestive problems

For many of us, oral health is only a concern when tooth or gum pain occurs. Otherwise, regular dental checks are easily dismissed. However, this neglect can lead to a cascade of issues that include worsening cavities and gum disease as well as heightened risk for digestive problems. This might come as a surprise as the mouth and the gut appear to be completely separate. Professor Seow Liang Lin, dean of IMU University's School of Dentistry explained, 'Bacteria from gum disease can cross the blood barrier and survive gastric juices, allowing it to populate the gut and affect the balance of good gut bacteria that help with digestion. 'It is medically well-established that patients with gum disease are more likely to have inflammatory conditions of the gut such as inflammatory bowel disease (IBD) and Crohn's disease.' She added: 'The oral cavity and the gut harbour some of the most dense and diverse microbial communities; they share a common factor, which is the presence of good and bad bacteria that usually exist in balance. 'However, this balance can be disrupted by many factors, such as the presence of oral bacteria in the gut which releases toxins that trigger inflammation, while suppressing the good bacteria that helps to fight inflammation.' Similarly, digestive health issues can also have an impact on oral health. For example, the backflow of acidic stomach juices in patients with gastroesophageal reflux disorder (GERD) can erode teeth enamel, leading to thinning of tooth structure, irreversible tooth damage and sensitivity. Moreover, tooth loss has been found to be associated with a lower relative abundance of Faecalibacterium, which secretes short-chain fatty acids believed to have systemic anti-inflammatory effect. 'The relationship between oral health and gut health is more direct than most people realise, and oral health is more important than you think, because it can have an impact on your overall health and well-being. 'The oral cavity acts as a gate­way for microbial colonisation, shaping the composition of subsequent microbial communi­ties along the respiratory and digestive systems. 'Dental problems such as decay and gum diseases that have gone unnoticed may eventually lead to tooth loss and result in difficulty in chewing. 'This, in turn, may affect a person's food choices, such as avoiding meats or vegetables in favour of processed foods that are easier to bite into, and lead to malnutrition or constipation,' said Prof Seow. Another factor affecting oral health is smoking, which disrupts gum health in the oral cavity, triggers inflammatory responses in the mouth and reduces blood supply to the gums, leading to gum inflammation. Oral health redefined With ongoing research, more connections between oral health and other diseases may be established, but the existing data on gut health is already compelling and a good reminder to make oral health an important aspect of health. This means getting regular check-ups to detect problems early, when they can still be remedied e.g. tooth decay can cause sensitivity or pain, and thus prompt a visit to the dentist. However, gum disease can often progress without any pain and symptoms like bleeding are often ignored. Over time, the underlying bone structure will be compromised and the tooth become loose. By then, there is nothing that can be done to reverse it, pointed out Prof Seow. 'The usual advice is to see your dentist at least once a year but it is more relevant to look at your risk factors. 'If you have been practicing good oral hygiene and have no known issues, annual check-ups might be sufficient. 'However, the presence of tooth decay or gum disease, or the use of braces or other prosthesis that easily retain plaque, may require more regular attention, perhaps twice a year or even quarterly, depending on your dentist's recommendation,' she said. Prof Seow advocates making your dentist your trusted ally. 'Having a regular dentist who is familiar with your history can encourage more open discussion and education on oral care solutions that are relevant and effective for you,' she concludes.

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