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FDA teams with Veterans Health Administration to make medtech supply chains more resilient

Dive Brief The U.S. Food and Drug Administration and the Veterans Health Administration have signed an agreement to increase medical product manufacturing capacity and flexibility in times of crisis. The agencies will create “digital stockpiles” to improve the resilience of domestic supply chains during emergencies, shortages and pandemics. The digital stockpiles will store electronic plans, instructions and methods to make and test medical products to enable trusted suppliers to quickly scale up production when needed, according to the agencies. Dive Insight The COVID-19 pandemic exposed the shortcomings of existing supply chains. When the crisis struck, the U.S. and other countries struggled to meet demand for personal protective equipment and other medical devices used in the response to the coronavirus. The experience led officials to consider how to make supply chains more resilient and able to cope with crises. Now, the FDA has signed a memorandum of understanding with the VHA. ...
- Source: drugdu
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- May 26, 2023
ElevateBio Takes Title of Largest 2023 Funding with $401M Series D

By Tristan Manalac Pictured: Hundred dollar bills/courtesy of Nomad_Soul/Adobe Stock On Wednesday, ElevateBio closed a $401 million Series D financing round, making it biotech’s largest private fundraising haul this year. The Massachusetts-based company will use the money to improve further the company’s gene editing, RNA, cell, vector engineering, protein and induced pluripotent stem cell technologies. ElevateBio will funnel these funds into BaseCamp, the company’s end-to-end genetic medicine cGMP manufacturing and process development business. Beyond advancing its platforms, ElevateBio will also use its Series D raise to broaden its geographic reach and increase its manufacturing capacity to satisfy the needs of its industry and academic partners. Wednesday’s funding round follows ElevateBio’s $525 million Series C in May 2021, one of biotech’s largest fundraises of that year. Since then, the company has further solidified its presence in the gene therapy space. In October 2021, ElevateBio bought biotech start-up Life Edit Therapeutics, whose ...
- Source: drugdu
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- May 26, 2023
FDA Delays Decision on Sarepta’s DMD Gene Therapy

By Heather McKenzie https://www.biospace.com/ Pictured: Sarepta logo on a building/courtesy of Sarepta Therapeutics Those in the Duchenne muscular dystrophy and gene therapy spaces hoping for a milestone decision by May 29 will have to wait approximately three more weeks as the FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease. The FDA told the company Wednesday “it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions,” according to Sarepta’s announcement. The company went on to say that the FDA indicated it is “working toward potentially granting an accelerated approval for SRP-9001” for DMD patients aged 4-5 years. If approved, SRP-900 would be the first FDA-authorized gene therapy for DMD. Sarepta’s shares were down 14% in pre-market trading Wednesday.
- Source: drugdu
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- May 26, 2023
New vaccine boosts hopes of eliminating meningitis across Africa

A trial of a new vaccine against meningococcal disease, a cause of meningitis and blood poisoning, has found that it is safe and induces a strong immune response across five strains of meningococcal bacteria: A, C, W, Y and X. The phase 3 trial compared the immune response generated by the new pentavalent vaccine NmCV-5 against that of the licensed quadrivalent MenACWY-D vaccine in 1,800 healthy participants aged 2–29 in Mali and The Gambia. After 28 days, across all ages, the immune responses generated by a single dose of NmCV-5 were generally higher than those generated by MenACWY-D. In addition, NmCV-5 induced a strong immune response to the emerging meningococcal X strain for which there is currently no licensed vaccine. The trial found no safety concerns with NmCV-5. The study, led by a team including researchers from the Medical Research Council (MRC) Unit, The Gambia, at the London School of ...
- Source: drugdu
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- May 26, 2023
Sudden infant death syndrome may have biologic cause

Sudden infant death syndrome (SIDS) is a case where the death of an apparently healthy infant before their first birthday remains unexplained even after thorough investigation. Death generally seems to occur when infants are sleeping. While rare, it is the leading post-neonatal infant death in the United States today, occurring in 103 out of 100,000 live births a year. Despite the initial success of national public health campaigns promoting safe sleep environments and healthier sleep positions in infants in the 1990s in the United States, rates of cases have remained the same over the last three decades. Researchers here collected tissue from the San Diego Medical Examiner’s Office related to infant deaths between 2004 and 2011. They then examined the brain stems of 70 infants who died during the period and tested them for consistent abnormalities. They found that the serotonin 2A/C receptor is altered in sudden infant death cases ...
- Source: drugdu
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- May 26, 2023
Research finds fever to be the most common non-respiratory feature of SARS-CoV-2 infection

Fever was found to be the most common non-respiratory feature of infection with SARS-CoV-2, the virus that causes COVID-19, according to research published at the ATS 2023 International Conference. The finding held true regardless of which COVID variant patients had, and whether or not they were fully vaccinated or not fully vaccinated. The researchers, who also looked at mortality risk, found that patients who were not fully vaccinated had a higher risk of dying when infected with either the Omicron or Delta variant. The study was based on the examination of the University of California Health Covid Research Data Set’s (UC CORDS) medical records of 63,454 patients who had been treated in a University of California medical center for COVID-19. The scientists applied statistical tests to determine the relationship between non-respiratory features, vaccination status and differences in mortality between infection with the Omicron and Delta variants. We determined that we ...
- Source: drugdu
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- May 25, 2023
FDA warns Sure-BioChem over quality and data issues

By Tyler Patchen News Reporter https://endpts.com/fda-warns-sure-biochem-over-quality-and-data-issues/ A warning letter has been given to a company that tests finished drug products over several quality issues. The FDA issued the warning letter to Sure-BioChem Laboratories, a Camden, NJ-based contract test laboratory that does microbial testing on products including finished drugs. Sure-BioChem was inspected late last year, but the regulator has advised the company that it still needs to make some corrections. The letter said that inspectors found that the company had failed to establish and follow procedures for some of its tests and it had not validated its use of “alternative microbial methods” used to test drug products to ensure that its methods were “Specifically, you failed to adequately establish that your microbiological testing methods can reliably detect objectionable microorganisms,” the letter said. Sure-BioChem’s methods also failed to detect Burkholderia cepacia complex (Bcc) bacteria and reported “not detected” to a client. The ...
- Source: drugdu
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- May 25, 2023
Roche Terminates Second Phase II Schizophrenia Trial

By Kate Goodwin https://www.biospace.com/ Pictured: Blue Roche logo on white building/Smith Collection/Gado/Getty Images Roche has terminated a second Phase II trial of its investigational schizophrenia drug ralmitaront, leaving an uncertain future for the company’s program targeting the psychiatric disorder. The first trial, which was canceled last year, was studying the effects of ralmitaront as a monotherapy in patients with an acute exacerbation of positive symptoms of schizophrenia or schizoaffective disorder. The second trial, which was recently terminated, was investigating the impact of the treatment on negative symptoms associated with the two conditions. “In a preliminary analysis, the primary endpoint was negative, and ongoing portions of the study have therefore been discontinued,” according to an update on the second Phase II trial posted to the ClinicalTrials.gov website. Roche’s latest first quarter 2023 pipeline presentation included the asset, pushing its New Molecular Entity submission back into the “2026 and beyond” category. No ...
- Source: drugdu
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- May 25, 2023
analysts

Dive Brief: Growth in parts of the orthopedic market will start to normalize late this year as surgeons work though a backlog of cases that had been postponed by the COVID-19 pandemic, analysts at Needham wrote. The analysts expect hip growth to normalize late this year and the knee and spine markets to slow down by the end of 2024. In the trauma and extremities market, the analysts see potential for “above-normal growth for some time.” A slowdown in capital spending by hospitals, currency fluctuations and supply chain issues are among factors the analysts said could hurt revenue for a number of the orthopedic companies. Dive Insight: Orthopedic companies have made a fast start to 2023, with Zimmer Biomet’s CEO saying “pretty much everything went better than expected” in the first quarter and an analyst admitting to being “kind of blown away by how good the growth rates were in ...
- Source: drugdu
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- May 25, 2023
Indivior’s Opvee crosses FDA finish line, adding new overdose rescue option amid raging opioid epidemic

Just two months after Emergent BioSolutions made history by winning the FDA’s blessing to sell its opioid reversal medicine over the counter, a new treatment option has arrived in Indivior’s Opvee. The nod, which covers Opvee’s use in people 12 years of age and older, marks the first approval for the medicine’s active ingredient in nasal spray form. The molecule, nalmefene hydrochloride, was first approved in the 1990s in an injectable format but was later pulled from the market in 2008. This time around, the FDA endorsed the drug based on new evidence that it can help combat rising overdose rates in the U.S. Indivior, which closed its purchase of Opiant in March and picked up the medicine in that buyout, plans to launch Opvee in the fourth quarter of 2023. The FDA’s approval comes as overdoses attributable to synthetic opioids such as fentanyl are on the rise, with more ...
- Source: drugdu
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- May 25, 2023

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