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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
- 139
- 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
- 169
- 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
- 109
- September 28, 2023
Enovis inks $847M acquisition to boost orthopedic reconstruction business

Dive Brief Enovis has struck an agreement to buy orthopedics company LimaCorporate for 800 million Euros ($847 million). The acquisition of the Italy-based company will scale Enovis’ global reconstruction unit, creating a $1 billion business that is forecast to grow in the high single digits and generate $40 million in cost synergies over the next three years. Vik Chopra, an analyst at Wells Fargo, said the acquisition was “much larger than what we were expecting,” in a conference call with Enovis management. Shares in Enovis rose 5% to $54.16 after the Delaware-based company disclosed the deal. Dive Insight Enovis, formerly called Colfax, has grown its operations through a series of acquisitions since the start of the decade, globalizing its reconstruction business with the $285 million takeover of Mathys in 2021 and adding other assets to establish and build its foot and ankle business. “At the time [of the Mathys deal], ...
- Source: drugdu
- 104
- 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
- 104
- 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
- 104
- 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
- 113
- September 28, 2023
Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer

By Tristan Manalac Pictured: Novartis logo on its office in California/iStock, JHVEPhoto Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate) met its primary endpoint in the Phase III NETTER-2 trial in gastroenteropancreatic neuroendocrine tumors, the company announced Monday. NETTER-2 is a randomized and open-label trial that evaluated Lutathera as a first-line option in 222 patients with grade 2 or 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Only those whose cancers were positive for the somatostatin receptor (SSTR) were eligible for enrolment into NETTER-2. When used in combination with high-dose long-acting octreotide, Lutathera led to a significant improvement in progression-free survival (PFS)—the study’s primary endpoint—compared with octreotide alone. In terms of safety, NETTER-2 did not find any new signals of concern and Lutathera’s adverse event profile in the study was consistent with what had been previously established. Novartis did not provide specific efficacy and safety figures, though it promised to do so ...
- Source: drugdu
- 137
- September 28, 2023
COVID-19 possible key in identifying viruses with pandemic potential

A study conducted by researchers at University College London and published in Cell revealed that if the protein mechanisms of COVID-19 variants are similar to those of other coronaviruses, it could potentially make identifying coronaviruses viruses with pandemic potential easier. The researchers looked at both the innate and adaptive immune systems – the two parts that form the human immune system. Innate immunity acts as the first line of defence. It is present from birth and tries to prevent infection spreading through a rapid response. Adaptive immunity, developing throughout our lives, enables us to recognise future pathogens by learning from past infections. The study, which focused on the ability of the most infectious COVID-19 variants to overcome our innate immune systems, found that variants could increase the production of proteins called Orf6, Nucleocapsid (N) and Orf96, to defeat our first line of defence. As a result, the virus has evolved ...
- Source: drugdu
- 101
- September 28, 2023
Acesion wins €45m in Series B funding to develop atrial fibrillation therapy

Danish biotech Acesion Pharma has raised €45m in an oversubscribed Series B financing round. The money will go towards funding the clinical development of the company’s atrial fibrillation therapy, AP31969. The investors that took part in the Series B financing round include Canaan, Alpha Wave, Global BioAccess Fund and Novo Holdings. AP31969 is an oral SK ion channel inhibitor that is being developed as a maintenance treatment to prevent the recurrence of atrial fibrillation. In March, Acesion announced that more than 50% of the participants in the Phase II AP31969 trial (NCT04571385) reported atrial fibrillation conversion to normal sinus rhythm within 90 minutes of infusion start, compared to zero participants in the placebo group. Atrial fibrillation is the most common form of arrhythmia or abnormal heart rhythm in which the top chambers of the heart (the atria) quiver or twitch, which is known as fibrillation. The US Centers for Disease ...
- Source: drugdu
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- September 28, 2023

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