Universal Health Services announced that, through its UK subsidiary Cygnet Health Care, it has acquired The Danshell Group. Danshell owns and operates 25 facilities with a total of 288 beds in the United Kingdom. Cygnet Health Care will operate and manage these new facilities. The Danshell facilities support and care for adults living with learning disabilities, who may also have a diagnosis of autism, in specialist supported living, residential services and hospitals. Through this acquisition, the company expands into new service lines and new geographical areas, complementary to the existing UK portfolio.
Tuesday, July 31, 2018
Emergent BioSolutions Initiates Phase 1 Study of Zika Virus Therapeutic
- ZIKV-IG granted Fast Track designation by the U.S. Food and Drug Administration
Emergent BioSolutions Inc. EBS, +2.57% today announced the initiation of a Phase 1 clinical study to evaluate the safety and pharmacokinetics of ZIKV-IG, the company’s anti-Zika virus immune globulin, being developed as a therapeutic intervention against Zika virus disease. ZIKV-IG was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in December 2017.
“Zika is an important disease with global impact due to its profound effect on the fetus and child-maternal health,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent BioSolutions. “The World Health Organization has stated the urgent need for accelerated research and development for countermeasures for Zika given its potential to cause a public health emergency and the absence of efficacious drugs and vaccines for the disease. Emergent is focused on providing preparedness solutions that address public health threats and emerging infectious diseases. Our program, initiated in 2017, seeks to accelerate development of a Zika-specific immune globulin that leverages our proven platform technology, four decades of patient experience with hyperimmunes, and core competencies in advanced development and manufacturing.”
The FDA’s fast track process is designed to facilitate the development and expeditious review of products to treat serious conditions and fill an unmet medical need. The main purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation could mean more frequent meetings and/or communications between the sponsor and FDA, eligibility for priority review of a Biologics License Application (BLA) if relevant criteria are met, and/or a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.
ZIKV-IG is a purified human immunoglobulin containing neutralizing antibodies to Zika virus. It is being developed on the company’s human hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Emergent’s Anthrasil [(R)] [Anthrax Immune Globulin Intravenous (Human)] and VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) products.
This Phase 1 double-blind, randomized, placebo-controlled clinical study will enroll approximately 30 healthy volunteers at a single site.
Progenics price target raised to $16 from $14 at Needham
Needham analyst Chad Messer raised his price target on Progenics to $16 after the FDA approved Azedra for intravenous use for certain types of locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. Messer keeps a Strong Buy rating on Progenics shares.
Sienna has bigger value drivers than SNA-001 in acne, says BMO Capital
BMO Capital analyst Gary Nachman called Sienna Biopharmaceuticals’ announcement that SNA-001 failed in two of its three pivotal studies in acne an “unfortunate outcome,” but he believes the bigger long-term value drivers for Sienna remain SNA-001 for light-hair removal and SNA-125 for psoriasis and atopic dermatitis. After removing any SNA-001 acne revenue from his estimates, Nachman lowered his price target on Sienna Biopharmaceuticals to $27 from $30 and keeps an Outperform rating on the shares
Pfizer CEO sees Trump eliminating drug rebates
Pfizer CEO Ian Read said he believes the Trump administration plans to stop the practice of allowing rebates on prescription drug purchases, indicating that U.S. drug pricing reforms may focus on middlemen instead of drug makers, Reuters reports. “I believe the administration does want to remove rebates, and they consider it a priority,” Read said in an interview
Greenlight shorting Athenahealth again after recent spike
Greenlight says the activist involved with Athenahealth has “little interest” in buying the company, according to Bloomberg.
Prevent the number one cause of accidental child death
Last month, Olympic skier Bode Miller and his wife, Morgan, lost their 19-month-old daughter, Emeline, after she drowned in a neighbor’s pool.
Now the couple is determined to raise awareness about child drowning, which is the leading cause of unintentional deaths for children 1 to 4 years old, according to a report by the Consumer Product Safety Commission.
Three hundred fifty-one children younger than 15 died in pool or spa-related drownings per year, between 2013 and 2015, according to a report by the organization.
The best way to prevent these accidents is to ensure that pools have four-sided fencing, including fencing between the pool and the door that leads to it, Philip Patrick Mularoni, the medical director of the Pediatric Sports Medicine Division at Johns Hopkins, tells The Post.
“When a child is in or near the pool, an adult should always be within reach of the child,” says Mularoni, who’s based in St. Petersburg, Fla. “And someone should be designated to watch the child or children, in case other adults get distracted.”
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