Search Results for “FDA” – Page 154 – media

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
- 106
- April 25, 2023
Apellis’ immune system drug hits a setback in ALS

Jacob Bell Senior Reporter In the latest setback for ALS research, Apellis Pharmaceuticals, a Massachusetts-based drug company, has discontinued a portion of a key clinical trial testing one of its medicines as a treatment for the nerve-destroying disease. The “MERIDIAN” trial began in the fall of 2020, ultimately enrolling around 250 participants who were given either a placebo or Apellis’ medicine, known as pegcetacoplan, over a two-year period. Following that period, participants could join a so-called “open-label extension” study, in which everyone would have access to the drug. But Apellis has chosen to stop that latter study, based on feedback from an external group of advisers who reviewed the data available and concluded further treatment with the drug was unwarranted. Analysts at the investment bank Mizuho Securities were the first to report this development. According to the analyst Graig Suvannavejh, Apellis announced the study discontinuation through a “company communication” that clarified that the ...
- Source: drugdu
- 162
- April 25, 2023
US Supreme Court delays abortion pill access decision

By Nadine Yousif & Robin Levinson-King BBC News The US Supreme Court has extended until Friday a temporary block on limits to access of a popular abortion pill. A Texas judge suspended approval of abortion drug mifepristone on 7 April, questioning its safety. Parts of that decision were upheld on appeal, prompting the Biden administration to make an emergency request to the Supreme Court. It’s the most significant such case since the Supreme Court last year ended the nationwide right to abortion. The pill – used in more than half of abortions in the US – was first approved by the Food and Drug Administration (FDA) more than two decades ago. Here’s how we got here. What has happened so far? Earlier this month, a federal judge in Texas issued a preliminary injunction revoking the FDA’s approval for the drug while he hears a lawsuit brought by a group of ...
- Source: drugdu
- 135
- April 24, 2023
GSK to buy Bellus Health and its chronic cough drug for $2B

GSK on Tuesday said it will pay $2 billion to acquire Bellus Health, a Canada-based developer of an experimental drug for chronic cough that’s in late-stage clinical trials. Deal terms value each Bellus share at $14.75, roughly double their closing price on Monday. The companies expect the acquisition will close in the third quarter, and Bellus’ board has unanimously voted in its favor. Bellus’ drug, called camlipixant, is currently being tested in two Phase 3 studies of people with persistent cough that either doesn’t have a clear cause or can’t be relieved by treatment for an underlying condition. Results are expected in late 2024 and in 2025, respectively. With the Bellus deal, GSK will gain a drug that could compete with a similar treatment being developed by Merck & Co. Both medicines are designed to work by targeting a receptor known as P2X3, and could become the first ...
- Source: drugdu
- 335
- April 20, 2023
CDC signs off on additional Covid-19 booster doses for certain people

The US Centers for Disease Control and Prevention updated its recommendations on the Covid-19 vaccines on Wednesday to allow another dose of the bivalent booster for people who are 65 and older or who have weakened immune systems and who “want the option of added protection” against the coronavirus. The move aligns with Tuesday’s US Food and Drug Administration actions to allow these groups to get additional booster doses ahead of the fall vaccination campaign. On Wednesday, members of CDC’s Advisory Committee for Immunization Practices met to discuss the changes and expressed their support for them, although the committee did not vote. Monovalent mRNA vaccines, which protect only against the original strain of the coronavirus, will no longer be recommended in the United States, the CDC says. The updated bivalent shots from Moderna and Pfizer/BioNTech protect against the original strain as well as the BA.4 and BA.5 subvariants ...
- Source: drugdu
- 103
- April 20, 2023
Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved. Katie Hobbins | Apr 19, 2023 Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall. Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device. In the study, investigators analyzed devices approved through ...
- Source: drugdu
- 136
- April 20, 2023
Researchers discover critical protein for common bone growth disorder

A team led by UT Southwestern Medical Center researchers has discovered a protein that appears to be pivotal for traumatic heterotopic ossification (HO), a condition in which bone forms in muscles, tendons, and other soft tissues after traumatic injury or surgery. The findings, published in Science Advances, could yield new ways to prevent this common complication, the researchers say. “Right now, we have no ways to prevent HO from occurring, which can cause significant impairments in quality of life. For example, it can alter patients’ range of motion, producing chronic pain, and affect the ability of amputees to fit into prostheses,” said Benjamin Levi, M.D., Associate Professor of Surgery and Plastic Surgery, and Chief of the Division of Burn, Trauma, Acute, and Critical Care Surgery at UT Southwestern. “Hopefully, these new findings will lead to treatments that can stop this process from unfolding so patients never develop it.” HO occurs when cells ...
- Source: drugdu
- 140
- April 19, 2023
EPA proposes new ethylene oxide rules for medical device sterilization

April 12, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn New ethylene oxide rules from the EPA would reduce EtO emissions from commercial sterilizers by 80%, the agency said. The EPA this week proposed new regulations for companies that sterilize medical devices with EtO, following up on last week’s proposal for new EtO rules on chemical plants that make or store the sterilant. EtO is the most common method of medical device sterilization, used for around half of the 40 billion devices sterilized each year in the U.S. For some devices, there’s no alternative to EtO because gamma ray and electron beam sterilization can only be used on certain materials. FAQ: What is electron beam sterilization? But health risks for sterilization plant workers and neighbors have the EPA, FDA, Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) working together to reduce those risks without reducing sterilization capacity. “OSHA’s mission is to ...
- Source: drugdu
- 231
- April 19, 2023
Pre- and post-surgical immunotherapy-based treatment significantly improved lung cancer outcomes

Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
- Source: drugdu
- 116
- April 18, 2023
Higher Paxlovid uptake in winter 2022 could have prevented nearly 5,000 deaths

In a recent study published in the JAMA Health Forum, researchers in the United States estimated the reduction in coronavirus disease 2019 (COVID-19) mortality rates after the Paxlovid rollout. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were the third largest cause of mortality in the United States in 2022, and after the Food and Drug Administration (FDA) approved Paxlovid (nirmatrelvir and ritonavir), the test-to-treat strategy became a pillar of the US pandemic response. Treatment with Paxlovid necessitates testing and medication initiation within five days after COVID-19 symptoms start. However, the population-level effect of the Paxlovid rollout has not been evaluated. About the study In the present study, researchers estimated the simulated influence of the Paxlovid rollout on COVID-19-related hospitalizations and deaths. The team modeled COVID-19-related hospitalization and death rate reductions after Paxlovid introduction as the product of (1) the number of symptomatic patients diagnosed within five ...
- Source: drugdu
- 100
- April 17, 2023

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