Can Adults Get RSV? Symptoms, Diagnosis, Vaccines
The FDA Isn't Afraid To Yank A Disappointing Drug
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Good morning, everyone. Damian here with a look at some renewed interest in a yesteryear biotech craze, news of an FDA flex, and a dive into the science of vaccinology.
The need-to-know this morningFor years, the prevalent fatty liver disease known as NASH was that rarest of pharmaceutical opportunities: a massive potential market without a single approved treatment. The industry's interest seemed to subside after a metronomic series of clinical disappointments, but in 2024, the disease now called MASH is back in the spotlight thanks to a boom in obesity research.
As STAT's Elaine Chen reports, about one-fifth of the 105 treatments in development for obesity are also being studied in MASH, short for metabolic dysfunction-associated steatohepatitis. It makes sense scientifically, as patients who develop MASH typically progress from obesity. And the commercial potential remains clear, as 1.5% to 6.5% of U.S. Adults are estimated to have MASH, meaning any drug that reaches even a fraction of those patients would be a multibillion-dollar product.
What remains unclear is just how the market might shake out. Medicines like Wegovy and Zepbound, which lead to significant weight loss, have demonstrated promising effects on liver fat, helping some patients achieve MASH resolution. But they might not improve the liver scarring that accompanies more advanced cases of the disease, leaving room for novel therapies with different biological targets.
Read more.
Alnylam's plea patience is working outShares of Alnylam Pharmaceuticals fell about 10% earlier this month after the company made some 11th-hour changes to an all-important Phase 3 study. The company has spent the last week or so making its case for why those late-inning amendments are not cause for alarm, and, at least according to the stock price, it's working.
As STAT's Adam Feuerstein writes, Alnylam has almost fully recovered since it first disclosed a delay to Helios-B, a study testing whether the RNA-interference therapy called vutrisiran can improve the lives of patients with the progressive heart disease ATTR-CM.
According to CEO Yvonne Greenstreet, the company made its decision after seeing longer follow-up data on the outcomes of people with ATTR-CM treated with another Alnylam medicine called patisiran, along with late-stage study results presented by BridgeBio on its competing treatment for ATTR-CM called acoramidis. "Everything we've seen actually makes us very confident about the study delivering its outcome," Greenstreet said.
Read more.
The FDA isn't afraid to yank a disappointing drugThe FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, the agency's first exercise of a new authority that allows regulators to more quickly withdraw drugs that have not lived up to their promise.
The decision concludes a seven-month process that began after Oncopeptides' drug, which won accelerated approval in 2021, failed in a Phase 3 study meant to confirm its observed benefits. The FDA moved to rescind approval of the drug, called Pepaxto, and Oncopeptides appealed. In a letter issued Friday, Peter Marks, head of the agency's biologics division, overruled the company's arguments and ordered the withdrawal of Pepaxto. In a statement, Oncopeptides said it will "thoroughly assess the decision."
The move comes amid increased scrutiny of the FDA's accelerated approval program, which allows novel drugs to reach the market based on preliminary signs of efficacy while larger trials continue. Public health advocates have argued that drug companies abuse the system, pointing out that it takes nearly four years for ineffective drugs to have their accelerated approvals withdrawn.
The next flu vaccines will look familiarThe World Health Organization issued recommendations Friday on which flu viruses the next vaccine should target. There was good news for manufacturers: People in the Northern Hemisphere will get the same flu shot next winter that people in the Southern Hemisphere are getting to prepare for their upcoming flu season. In fact, the component of the vaccine that targets the flu B Victoria lineage has been unchanged since the 2022 vaccine for the Southern Hemisphere.
Why is this good for manufacturers? Learning to optimize growth of a new virus can take time. Since they have worked extensively with these viruses, manufacturers will know how to grow them.
In its report, the WHO reiterated it would like manufacturers to make trivalent vaccines, containing only viruses targeting influenza A viruses H1N1 and H3N2 plus B/Victoria. But it acknowledged some national regulatory agencies may not be ready to move away from quadrivalent formulations, which also target seemingly extinct B/Yamagata viruses.
The Food and Drug Administration's vaccine advisory committee will meet March 5 to formalize the formulation for next winter for the U.S.
More readsMarch United Against The Flu Toolkit Highlights The Hopefulness Of Spring
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Global Paediatric Influenza Treatment Industry Poised For 3.5% CAGR Advancement, Aiming At US$ 847.7 Million By 2032FMI
The Global Paediatric Influenza Treatment Industry is on the brink of a significant evolution, projecting a remarkable surge from US$ 578.2 million in 2022 to an impressive US$ 847.7 million by 2032. Fueled by a robust Compound Annual Growth Rate (CAGR) of 3.5% over the forecast period from 2022 to 2032, this growth paints a promising picture for the industry's future.
The forecast indicates that developed markets are poised to experience the swiftest growth in revenue generation, outpacing their developing counterparts. The disparities in awareness levels, particularly in less developed countries, underscore the critical need for advancements in pediatric influenza treatment. The correlation between awareness and mortality rates highlights the urgency of establishing a robust market with innovative treatments.
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Influenza is also known as the flu. It is a sickness caused by a respiratory infection. The disease can spread quickly through groups as the infection is passed from individual to individual, especially children. Mainly caused by influenza A or influenza B virus, which happens in outbreaks worldwide consistently, primarily during the winter seasons in calm atmospheres. The disease goes ahead quick and is more exceptional than a cold. Children tend to feel more uncomfortable during the initial 2 or 3 days they're affected.
Symptoms include high-grade fever up to 104 degrees F, chills and shakes during fever, extreme tiredness, headache and body aches, dry, hacking cough, vomiting and belly pain, and other symptoms. Flu causes an obvious infection trouble (e.G. School and expanded recurrence of outpatient therapeutic visits), and youngsters are critical vectors for the spread of ailment. Immunization is an essential general well-being measure for the anticipation of flu disease. However, professionally prescribed medications or antiviral medications additionally might be utilized for counteractive action in high-hazard patients who have not been inoculated or who may have an imperfect reaction to the immunization and can be utilized to treat flu or to prevent the flu in the pediatric influenza treatment market.
Treatment with antiviral therapeutic drugs may lessen additional serious influenza-related complications like pneumonia and hospitalizations. People can opt for approved antiviral medicines such as oseltamivir (Tamiflu) or zanamivir (Relenza). Other treatments proposed by healthcare professionals include plenty of rest, plenty of fluids, and usage of acetaminophen or ibuprofen to lower fever and ease aches.
Global Paediatric Influenza Treatment Industry: Drivers and Restraints
Antiviral prescriptions are viable for the counteractive action of flu, and, when utilized for treatment, can diminish the span and seriousness of the disease. Early antiviral treatment can decrease the danger of serious illness or death identified with flu. In any case, the development of imperviousness to at least one of the four authorized antiviral specialists (oseltamivir, zanamivir, amantadine, and rimantadine) among some flowing flu infection strains during the previous 5 years has confounded antiviral treatment and chemoprophylaxis suggestions.
Expanding indications of flu between the age group of 1 to 9 years coupled with a rise in the usage of antiviral drugs have added a major contribution to the overall growth of the market. Also rising approvals for medications such as Mainly three influenza antiviral medicines approved by the U.S. (FDA) are prescribed for use in the U.S. During the 2016-2017 flu season: oral oseltamivir (accessible as a generic drug or under the exchange name Tamiflu), zanamivir ( Relenza – trade name) and intravenous peramivir (trade name Rapivab).
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These medications are artificially related antiviral drugs known as neuraminidase inhibitors that have action against both influenza A and B infections. Late innovative headways in restorative antiviral drugs for treating different types of this sickness have additionally caused an expanded request worldwide, which will keep on contributing towards the development of pediatric influenza treatment during the forecast period.
However, there are factors such as a limited number of treatment options in developing economies coupled with the high very high cost of branded drugs, expensiveness, and inefficient usage of low-cost non-prescribed drugs, less availability of antiviral drugs with improper guidelines in various regions, and monopoly of few players, which have impeded the growth of the market.
Pediatric Influenza Treatment Industry: Region-Wise Outlook
North America region is expected to witness faster revenue growth in comparison with markets in other regions. The reasons for the same are higher infection rates amongst children, higher cost of antiviral drugs, and a large population of patients of young age (1-9 years) suffering from pediatric influenza.
Higher awareness levels among physicians and frequent publication of results of upcoming treatments tend to create a positive sentiment in the region, which is absent in other regions such as the Middle East Africa, and Asia. Considerable research efforts toward the development of novel vaccines/drugs and innovative medication regimens are factors expected to aid the revenue growth of the market over the forecast years.
Global Paediatric Influenza Treatment Industry Key Players
A few key players in the global cervical dysplasia treatment market are GlaxoSmithKline Plc., NATCO Pharma Limited., NESHER PHARMS, F. Hoffmann-La Roche Ltd, Atabay Kimya Sanayi ve Ticaret A.S., Cipla, Hetero Pharma, Teva Pharmaceutical Pvt. Ltd., and Olainfarm JSC.
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Regional analysis includes
The report is a compilation of first-hand information, qualitative and quantitative assessments by industry analysts, and inputs from industry experts and industry participants across the value chain. The report provides an in-depth analysis of parent market trends, macroeconomic indicators, and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.
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Global Paediatric Influenza Treatment Industry: Segmentation
Based on the treatment type
Based on the end-user
Report Highlights:
Author
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
About Future Market Insights (FMI)
Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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