Search Results for “EC” – Page 359 – media

Alto Reports Positive Phase II PTSD Data After Mid-Stage MDD Win

By Tristan Manalac Pictured: Cracked figure of a head symbolizing distress/iStock, designer491 Alto Neuroscience on Tuesday announced that its investigational drug ALTO-100 showed a favorable efficacy and safety profile in a Phase IIa trial in patients with post-traumatic stress disorder. The study also demonstrated that Alto’s precision psychiatry approach could lead to better outcomes for post-traumatic stress disorder (PTSD) patients. In a subgroup of patients defined by a certain cognitive profile, treatment with ALTO-100 reduced scores in the clinician-administered PTSD scale for DSM-5 (CAPS-5) by 17.5 points. In contrast, the candidate improved CAPS-5 scores by only 12.9 points in patients without this cognitive profile. The difference was statistically significant, indicating that the company’s approach could identify potential drug responders by looking at patients’ neurobiological profiles, according to Alto’s announcement. In addition, in the biomarker-defined patients, ALT-100 elicited a clinical response rate of 46% compared to only 26% in those without ...
- Source: drugdu
- 159
- September 29, 2023
mRNA Vaccine Manufacturing Comes to Africa

By Clemence Manyukwe Pictured: The first BioNTainer arrives in Rwanda/BioNTech German biotech company BioNTech has said it will start manufacturing vaccines in Africa within 18 months after completing a manufacturing facility in Rwanda, a milestone the company stated it expects to reach by the end of this year. The company is also planning to set up plants in two other African countries, South Africa and Senegal, as part of what it describes as an effort to democratize access to novel medicines around the globe. “Core to BioNTech’s business practices is to improve the health of people worldwide,” a company spokesperson told BioSpace in an email. To launch its manufacturing presence in Africa, BioNTech introduced its BioNTainer, a flexible container solution delivering turnkey mRNA manufacturing facilities for scalable mRNA vaccine production. “The BioNTainer was developed to help ensure sustainable, equitable access to mRNA-based medicines in countries and regions where they are ...
- Source: drugdu
- 92
- September 29, 2023
Short-term exposure to air pollution may increase stroke risk

Short-term exposure to air pollution may be linked to an increased risk of stroke, according to a meta-analysis published in the September 27, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. Short-term exposure was defined as occurring within five days of the stroke. Ahmad Toubasi, MD, study author, University of Jordan in Amman, said, “Previous research has established a connection between long-term exposure to air pollution and an increased risk of stroke. However, the correlation between short-term exposure to air pollution and stroke had been less clear. For our study, instead of looking at weeks or months of exposure, we looked at just five days and found a link between short-term exposure to air pollution and an increased risk of stroke.” The meta-analysis involved a review of 110 studies that included more than 18 million cases of stroke. Researchers looked at pollutants such as ...
- Source: drugdu
- 209
- September 29, 2023
Siemens Healthineers buys Aspekt to bolster radiation oncology services

Dive Brief Siemens Healthineers has acquired Aspekt Solutions to strengthen the service offering at its Varian cancer therapy unit. Neither party disclosed the value of the deal. Aspekt supports radiation oncology sites — the type of health centers that use Varian devices — with services such as dosimetry consulting, clinic management, technology evaluation and staffing. Varian sees the acquisition as complementary to its Advanced Oncology Solutions unit, which provides professional and clinical services to improve the implementation of its technologies. Dive Insight Varian, a provider of radiation oncology equipment and software, pitches its AOS unit as enabling sites to adopt technologies, improve quality and expand capacity. The unit collaborates with radiation oncology sites to simplify data entry, optimize databases, reduce variation between dosimetrists and train staff on safety. In doing so, Varian aims to address challenges such as the rising cost of care and staff shortages. “Through our AOS offerings, ...
- Source: drugdu
- 99
- September 29, 2023
Virgin Pulse, HealthComp To Merge Through $3B Deal

As a combined entity, Virgin Pulse and HealthComp will serve more than 1,000 self-insured employers and more than 20 million members. New Mountain Capital will be the majority owner. By MARISSA PLESCIA Navigation company Virgin Pulse and benefits and analytics platform HealthComp announced Wednesday that they plan to merge to create an integrated platform for employer-sponsored benefits. The $3 billion deal was first reported by The Wall Street Journal. Providence, Rhode Island-based Virgin Pulse works with employers, health plans and health systems. It offers a navigation platform called Homebase for Health, which provides access to motivating challenges, lifestyle coaches and specialty partner programs. Fresno, California-based HealthComp works with employers, brokers and providers. It offers claim protection and integrity, clinical care management programs, customizable technology, a customer service model and data-driven reports. Virgin Pulse is backed by Marlin Equity Partners, while HealthComp is backed by New Mountain Capital, according to a ...
- Source: drugdu
- 133
- September 29, 2023
Azurity Pharmaceuticals Absorbs Slayback Pharma

The company expects to yield a significant number of new medicine launches from the acquisition. Azurity Pharmaceuticals, Inc. broke the news that it has officially acquired Slayback Pharma LLC from existing investors including KKR and Everstone Capital, making it a wholly owned subsidiary. According to Azurity, the acquisition is expected to realize its purpose of serving overlooked patients, hoping to yield a significant number of new medicine launches over the coming years. “I am delighted to announce this combination and the increased potential it brings to do more for overlooked patients,” said Richard Blackburn, CEO, Azurity. “The complementary expertise of the two companies in developing innovative dose forms will result in a strong pipeline of new medicines to meet the needs of patients. We will bring the commercial expertise of Azurity to Slayback’s pipeline and look forward to introducing an even wider range of dose-forms and formulations to meet a ...
- Source: drugdu
- 163
- September 29, 2023
Study finds mixed results for mobile health app in cardiac rehabilitation

Nearly one in three Americans wear a wearable device, like a smartwatch, to track their health and fitness. Studies have shown positive effects of increasing movement in ways that can be measured by these devices, especially for people who recently had a heart attack or other cardiovascular event. But a Michigan Medicine-led report shows that adding a mobile health application to such devices yields mixed results. Tailored text messages to encourage high-risk people to move more may improve some short-term outcomes but doesn’t always improve physical activity levels for everyone. The randomized clinical trial, called the Virtual AppLication-supported Environment To Increase Exercise Study, or VALENTINE, compared the physical activity levels of patients enrolled in cardiac rehabilitation who received the mobile health intervention to those who did not. Cardiac rehabilitation is a medically supervised program is recommended after cardiovascular events, such as heart attack or surgery. Of the more than 200 ...
- Source: drugdu
- 105
- September 28, 2023
Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner. By FRANK VINLUAN Ionis Pharmaceuticals has revenue from commercialized medicines, but those products reached the market in the hands of biopharma industry partners. The genetic medicines company does have wholly owned assets, and one of them now has preliminary Phase 3 data that put it on the path for an FDA submission. The drug, olezarsen, is a potential treatment for familial chylomicronemia syndrome, or FCS. The rare, inherited disease leads to the inability to break down triglycerides, which are fats consumed from food. High triglyceride levels can lead to acute pancreatitis, severe inflammation of the pancreas that can become fatal. Patients ...
- Source: drugdu
- 100
- September 28, 2023
FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use. Pharmaceutical companies are embracing new technologies that could potentially assist patients with taking medication in a safe and effective manner. In 2018, FDA began soliciting comments for a possible regulatory framework based around these technologies. In September 2023, the agency issued its draft guidance on the subject, explaining how drug sponsors should describe their software both in FDA required labeling and promotional labeling. For the required labeling, which includes prescribing information, the sponsor can submit evidence to FDA that the software results in a meaningful improvement in a clinical outcome as compared to when the patient takes the drug without using the software. If the evidence supports this, the label should include relevant information about the software and its use. If the software does not have a meaningful outcome on the use ...
- Source: drugdu
- 100
- September 28, 2023
Liquid, Oral Reformulation of Antibiotic Metronidazole

By Matt Olszewski Pictured: FDA signage at its office in Washington, D.C./iStock, JHVEPhoto Appili Therapeutics announced on Monday that the FDA has approved its liquid oral reformulation of the antibiotic metronidazole, ATI-1501, for the treatment of antimicrobial infections in patients with difficulty swallowing pills or who are unable to get injections. The drug is a prominent oral treatment with more than 10 million U.S. prescriptions annually. The injectable form of the drug, commonly used for treating parasitic and anaerobic bacterial infections, has been in shortage in the U.S. since last year due to extreme demand and regulatory delays, according to the American Society of Health-System Pharmacists “The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges,” according to Appili. Before the FDA’s approval ...
- Source: drugdu
- 103
- September 28, 2023

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