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After delay, Bluebird submits sickle cell gene therapy for FDA approval

Bluebird bio said Monday it has submitted its lovo-cel gene therapy for sickle cell disease for Food and Drug Administration approval, ending a brief delay as it awaited feedback from the agency on manufacturing. The Massachusetts-based drugmaker missed its goal to submit an application by the end of March, allowing Vertex Pharmaceuticals and CRISPR Therapeutics to jump ahead with an approval application for a competing therapy. The agency now has until late June to decide whether to accept Bluebird’s application. The company is seeking a “priority,” or expedited, review, which if granted would shorten the review from 10 months to six. Bluebird is planning for an expedited review and, should an approval be granted, an early 2024 commercial launch. Lovo-cel is viewed by analysts as Bluebird’s best chance for business success because many more people in the U.S. have sickle cell disease than the rarer conditions ...
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- April 26, 2023
New machine-learning method predicts body clock timing to improve sleep and health decisions

A new machine-learning method could help us gauge the time of our internal body clock, helping us all make better health decisions, including when and how long to sleep. The research, which has been conducted by the University of Surrey and the University of Groningen, used a machine learning program to analyze metabolites in blood to predict the time of our internal circadian timing system. The study is published in the journal Proceedings of the National Academy of Sciences. To date the standard method to determine the timing of the circadian system is to measure the timing of our natural melatonin rhythm, specifically when we start producing melatonin, known as dim light melatonin onset (DLMO). Professor Debra Skene, co-author of the study from the University of Surrey, said, “After taking two blood samples from our participants, our method was able to predict the DLMO of individuals with an accuracy comparable ...
- Source: drugdu
- 125
- April 26, 2023
Common ear, nose, and throat issues in preschoolers may be linked to later autism risk

Young children with common ear, nose, and throat (ENT) issues may be at subsequent risk of autism or high levels of demonstrable autism traits, suggests research published online in BMJ Open. Early identification and treatment of ENT conditions may improve these children’s quality of life and potentially help shed light on some of the origins of autism, say the researchers. The causes of autism are likely to involve an interplay of genetic, environmental, and biological factors, and the origins of each autistic trait may also differ, note the researchers. Previous research suggests that ENT conditions, such as ear infections, “glue ear,” and sleep-disordered breathing may have a role in the development of autism. But most of this evidence is based on health records, which may have biased these findings, because parents of children with suspected autism may be more likely than other parents to seek medical help for their offspring, ...
- Source: drugdu
- 121
- April 26, 2023
Seasonal Variation in Thyroid Hormone TSH May Lead to Overprescribing

By Miriam E. Tucker Seasonal variation in one of the hormones used to monitor thyroid function could in turn lead to false diagnoses of subclinical hypothyroidism and unnecessary prescriptions of levothyroxine, says Yale clinical chemist Joe M. El-Khoury, PhD. He says a Japanese study in more than 7000 healthy individuals showed that thyrotropin-stimulating hormone (TSH) varies widely throughout the seasons, peaking in the northern hemisphere’s winter months (January to February) with its low in the summer months (June to August); that paper was published last year in the Journal of the Endocrine Society. But free thyroxine (FT4) levels in the Japanese population remained relatively stable, he writes in a letter recently published in Clinical Chemistry. “If you end up with a mildly elevated TSH result and a normal FT4, try getting retested 2-3 months later to make sure this is not a seasonal artifact or transient increase before prescribing/taking levothyroxine unnecessarily,” advises El-Khoury, who is director of Yale University’s Clinical Chemistry Laboratory, ...
- Source: drugdu
- 131
- April 26, 2023
New study of age-related macular degeneration finds causal genes, dispels previous assumptions

by Justin Jackson , Medical Xpress A study led by the research center of Genentech in South San Francisco, published in Cell Genomics, has looked for drug targets that could address age-related macular degeneration (AMD), a condition at the center of vision problems for 200 million people worldwide. AMD can result in blindness. In the paper “A systems biology approach uncovers novel disease mechanisms in age-related macular degeneration,” the researchers describe the steps they took to identify genes targetable by treatment with a molecular atlas of AMD pathology development stages. The study resulted in the identification of 23 significant genome-wide loci that are differentially methylated in AMD. Over 1,000 differentially expressed genes were found across disease stages and distinct Müller cell states in AMD-affected eyes. The research highlights causal gene upregulations and underlying genetic risks for AMD. Researchers generated bulk-tissue and single-cell transcriptomics and epigenomics data from 85 unique human ...
- Source: drugdu
- 125
- April 26, 2023
Walnuts Linked to Improved Attention, Psychological Maturity in Teens

By Batya Swift Yasgur, MA, LSW Walnuts have been associated with better cognitive development and psychological maturation in teens, new research shows. Adolescents who consumed walnuts for at least 100 days showed improved sustained attention and fluid intelligence as well as a reduction in symptoms of attention deficit hyperactivity disorder (ADHD) compared with matched controls who did not consume the nuts. However, there were no statistically significant changes between the groups in other parameters, such as working memory and executive function. Clinicians should advise adolescents “to eat a handful of walnuts three times a week for the rest of their lives. They may have a healthier brain with better cognitive function,” senior investigator Jordi Julvez, PhD, group leader at the Institute of Health Research Pere Virgili and associated researcher at the Barcelona Institute for Global Health, told Medscape Medical News. The study was published online April 6 in Lancet Discovery Science (eClinicalMedicine). Rich Source of Omega-3s Adolescence ...
- Source: drugdu
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- April 26, 2023
OTC Narcan will cost ‘less than $50’, company says

The maker of the first opioid treatment drug to be sold OTC has announced a pricing plan weeks after an FDA approval for Narcan. Emergent Biosolutions, maker of the opioid overdose reversing nasal spray Narcan, intends to price the treatment at less than $50 for a kit of two 4mg doses for over-the-counter use (OTC) the company said in a statement. The company has said its goal is to have an out-of-pocket retail price that is in line with its publick interest pricing strategy. Public interest groups including government agencies, harm reduction groups, and emergency responders pay less than $50 out of pocket for one carton of the spray, according to Emergent. Additionally, its pricing for both public interest groups and retailers going forward would be less than the current Wholesale Acquisition Cost (WAC) price of $125. While justifying the price, the Emergent statement said the company needs to “foster a sustainable ...
- Source: drugdu
- 113
- April 25, 2023
BullFrog AI , Sage Group partner to develop oncology assets

Digital technology company BullFrog AI and Sage Group have entered into a strategic partnership to develop oncology assets. This partnership will focus on exploring joint venture (JV) opportunities for advancing a Phase II ready asset and the preclinical prodrug asset of BullFrog AI. The Phase II ready asset targets glioblastoma, which is an aggressive form of brain cancer. Through the collaboration, BullFrog AI will gain access to Sage Group’s capital resources, clinical and regulatory expertise, as well as contacts network, including innovators and large pharma. BullFrog AI founder and CEO Vin Singh said: “Glioblastoma is one of the deadliest forms of cancer, with a five-year survival rate of less than seven percent. “With the Sage Group’s support, we look forward to identifying the right partner to help us advance clinical development of our oncology programs globally in an effort to bring a revolutionary new treatment option to glioblastoma patients.” Recently, ...
- Source: drugdu
- 118
- April 25, 2023
Proper nutrition could boost recovery from traumatic brain injury

In the first few days after a traumatic brain injury (TBI), food is often an afterthought as clinicians focus on minimizing the damage to the brain. However, a new study suggests that getting enough calories can help boost the brain’s healing process, making nutrition an important consideration for improving TBI care. Researchers will present their work this week at the American Physiology Summit, the flagship annual meeting of the American Physiological Society (APS), in Long Beach, California. “This evidence highlights the importance of ensuring proper nutrition for TBI patients during recovery. Specifically, formulations containing fuels that are preferred by the brain, such as lactate, should be prioritized during the acute and chronic phases of recovery from TBI.” Casey C. Curl, Doctoral Candidate, Exercise Physiology Laboratory, University of California, Berkeley When a person comes to the hospital with a traumatic brain injury, many patients go for several days without ...
- Source: drugdu
- 139
- April 25, 2023
Drugmakers take sides in Amgen, Regeneron fight over antibody patents

Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects. At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol. Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...
- Source: drugdu
- 171
- April 25, 2023

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