Search Results for “EC” – Page 342 – media

FDA extends pandemic-era policy allowing certain device, production changes without prior approval

Dive Brief The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges. The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers during the crisis. The guidance document, issued Thursday, outlines examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes. While the policy was initially created for the emergency pandemic environment, the FDA wrote in the guidance document that it has “continued to observe supply chain challenges and shortages of medical devices remain widespread.” The agency removed the policy’s expiration date, but it could make revisions in the future. Dive Insight The guidance, first issued in May 2020, was supposed ...
- Source: drugdu
- 131
- November 5, 2023
Shark skin mucus shows potential for biomedical applications

Sharks differ from other fish in many ways, including an apparently remarkable ability to heal from wounds, according to reports of sharks recovering from injuries sustained in the wild. While this healing ability has not yet been documented in controlled laboratory conditions, some of the chemical compounds found in shark skin may have significant biomedical potential. To investigate this possibility, two dermatology researchers from the Karolinska Institute in Sweden carried out research on a small shark, the spiny dogfish (Squalus acanthias) and other cartilaginous fish species at the Marine Biological Laboratory (MBL) in Woods Hole. Their goal is to understand the unique biochemistry of the skin of these animals. Previous research on sharks in other labs has led to the development of a new antibiotic, and the discovery of biochemical pathways relevant to cystic fibrosis research. Jakob Wikström, associate professor of dermatology and principal investigator at Karolinska, and Etty Bachar-Wikström, ...
- Source: drugdu
- 114
- November 5, 2023
Prelude and AbCellera jump on the ADC train with partnership

Prelude Therapeutics and AbCellera have partnered to jointly discover, develop, and commercialise antibody-drug conjugate candidates (ADCs) for cancer treatment. The collaboration leverages Prelude’s expertise in targeted protein degradation, medicinal chemistry, and clinical development and AbCellera’s antibody discovery and development engine to generate novel precision ADCs. ADCs have been identified as a key innovation area by GlobalData, with multiple companies investing in these therapies. The most recent company to join this trend was MSD (Merck & Co), which signed a collaboration agreement with Daiichi Sankyo to develop and market three ADCs last month. Prelude will be responsible for the clinical development and global commercialisation, whilst AbCellera will lead the manufacturing activities for the ADCs. AbCellera will also have the option to co-promote the ADCs in the US, as per the 1 November press release. AbCellera generated $10.1m in revenue from discovery activity in Q2 2023, as per the company’s financials. AbCellera ...
- Source: drugdu
- 126
- November 5, 2023
Moderna posts reported net loss of $3.6bn in Q3 earnings

Moderna has posted a reported net loss of $3.6bn in its Q3 earnings compared to a net income of $1bn during the same period last year, in line with the decreasing Covid-19-related revenues seen across the sector this year. For the quarter ended 1 October 2023, the company reported a diluted loss per share of $9.53. Revenues also saw a decline of 32% to $3.4bn from $5bn in the same quarter of the previous year. In its earnings release, Moderna attributed the drop in revenues to the expected decline in global revenue generated by the Covid-19 vaccine Spikevax. Spikevax revenues saw a 42% drop against the same quarter in 2022, from $3.1bn to $1.8bn. Still, the US market share to date of Spikevax grew to 45% from 36% in 2022, and Moderna anticipates 2024 revenues of approximately $4bn and return to growth in 2025. Part of this sales projection is ...
- Source: drugdu
- 141
- November 5, 2023
Sangamo tightens the belt, cutting staff and assets to advance product pipeline

In a bid to further restructure operations, Sangamo plans to close its facility in Brisbane, California early in 2024, which will see 162 employees facing another round of layoffs. During the transition, the company will move its headquarters to its facility in Richmond, California, effective January 1, 2024. Sangamo will direct any freed resources towards advancing adeno-associated virus (AAV) capsid delivery technologies and its neurology epigenetic regulation portfolio via its investigational Nav1.7 and Prion disease therapies, said Sangamo CEO Sandy Macrae. Additionally, the company has decided to defer new investments for its Phase III Fabry and CAR-Treg studies and is instead actively seeking collaboration and investment partners for both programs. Sangamo is the latest to be swept in the wave of layoffs, following companies like NexImmune and Kinnate Biopharma, which sacked 53% and 70% of their respective workforces in September to redirect cash towards priority projects. In a conference call ...
- Source: drugdu
- 179
- November 5, 2023
CooperCompanies buys reproductive health products from Cook Medical after failed takeover

Dive Brief CooperCompanies bought some of Cook Medical’s obstetrics, doppler monitoring and gynecology surgery products for $300 million, the companies announced on Wednesday. The acquisition follows an attempt by Cooper to acquire Cook’s reproductive health business, which was scrapped amid scrutiny from the Federal Trade Commission. The assets included in the purchase do not include any of the fertility products the companies had discussed in the original deal, Cooper said. Dive Insight Cooper paid $200 million upfront and will pay two more annual installments of $50 million each. In exchange, it will acquire Cook’s Bakri postpartum balloon, cervical ripening balloon, doppler blood flow monitor portfolio and other surgical products. Cooper CEO Al White said in the deal announcement that the acquired devices “are highly synergistic” with the company’s current portfolio and will strengthen its position in fertility and women’s health. San Ramon, California-based Cooper’s surgery segment includes fertility, gynecology and ...
- Source: drugdu
- 159
- November 4, 2023
One in seven Americans have had long Covid, study finds

One in seven people in the US reported having had long Covid by the end of 2022, suggests a large-scale investigation of long Covid and symptom prevalence by academics at UCL and Dartmouth. Having had long Covid is associated with anxiety and low mood, as well as an increased likelihood of continued physical mobility problems and challenges with memory, concentration or understanding, according to the findings published in PLOS ONE. The risk of anxiety and low mood appeared to be lower for those who have been vaccinated, including for those who have had long Covid. Alex Bryson, Co-Author, Professor, UCL Social Research Institute, said, “Little is known about long Covid and its impact on health and wellbeing, but there is a growing body of evidence that many people experience persistent and concerning symptoms. Here, we have found that long Covid continues to affect millions of people in the US, with ...
- Source: drugdu
- 156
- November 4, 2023
Why Physicians in ACOs Are Happier With Their Compensation

Only 21% of primary care physicians feel they are fairly compensated, according to a new report from Pearl Health. However, primary care physicians who participate in an ACO were 56% more likely than non-ACO participants to believe they are paid fairly. ACO participants were also 15% more likely to believe that the way they generate revenue allows them to deliver holistic care. By KATIE ADAMS Only 21% of primary care physicians feel they are fairly compensated, according to a new report released by Pearl Health, a tech company that helps independent physician practices participate in value-based care models. For the report, the company collected survey responses from 202 primary care physicians from July 11 to October 9. Recent data shows that the three physician specialties with the lowest compensation rates are preventive, general practice and family practice. There is some irony to this given the fact that quality primary care ...
- Source: drugdu
- 140
- November 4, 2023
The Impact of GLP-1 Weight Loss Drugs on Patients, Healthcare Business

Don Tracy, Associate Editor The rise in popularity of GLP-1 weight-loss drugs, such as Ozempic, Wegovy, and Mounjaro, has had a wide-reaching impact across the healthcare industry and beyond. Image Credit: Adobe Stock Images/Dimid The launch of multiple glucagon-like peptide (GLP-1) drugs for weight loss—such as Ozempic, Wegovy, and Mounjaro—is expected to cause a major shakeup in the stock market, as millions of Americans are set to shed hundreds of millions of pounds over the next decade while reshuffling trillions of dollars in the process, according to expert analysis. Not only have these treatments helped patients shed a significant amount of pounds, but they have also shown efficacy treating other conditions as well. A recent drug trial by Novo Nordisk found that semaglutide, the active ingredient in Ozempic and Wegovy, could help people with kidney failure as well. As shares of Novo Nordisk and Mounjaro developer Eli Lilly increase, dialysis ...
- Source: drugdu
- 108
- November 4, 2023
Combination Vaccines Are Coming for Respiratory Diseases

By Kate Goodwin Pictured: A researcher at work in a Novavax laboratory/Novavax, Patrick Siebert Combination vaccines are nothing new for the healthcare industry. Childhood vaccines, as well as a single shot for tetanus, diphtheria and pertussis for adults, have long been combined for ease of administration and increased compliance rates. Now, as vaccines for COVID-19 and, for older people, RSV and pneumococcal disease join the annual flu shot as routine care recommendations for adults, healthcare professionals are increasingly concerned over getting the word out, vaccine fatigue and logistical hurdles. Biopharma companies are betting there will be a market for vaccines that combine protection against two or more diseases in a single jab. Benefit to the Population “The data are pretty unequivocal that when there are combo vaccines available, people generally prefer [them],” said Andrea C. Love, an immunologist and microbiologist and founder of the Unbiased Science Podcast. Love pointed out ...
- Source: drugdu
- 107
- November 4, 2023

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