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Monday, June 24, 2019

Tenet and Aetna sign multi-year agreement

Tenet Healthcare (THC -0.5%) and Aetna, a CVS Health (CVS -0.3%) has entered into a new multi-year agreement providing Aetna with continued in-network access to all of Tenet’s hospitals, emergency centers, outpatient centers and employed physicians.
The agreement is for a term of 4 years with an option to extend for a 5th year.
“This agreement supports the hard work of our thousands of caregivers who are passionate about keeping our communities healthy and ensuring access to the very best care.” said Ron Rittenmeyer, Executive Chairman and CEO of Tenet.

Krystal Biotech (KRYS) PT Nearly Doubled to $67 at Cantor Fitzgerald

Cantor Fitzgerald analyst Elemer Piros raised the price target on Krystal Biotech (NASDAQ: KRYS) to $67.00 (from $34.00)

Minerva Neurosciences trial of insomnia treatment meets main goals

Minerva Neurosciences Inc. shares NERV, +63.12% soared 34% in premarket trade Monday, after the company said its trial of Seltorexant as a treatment for insomnia met its primary and key secondary goals. The company said the Phase 2b trial of the drug met its primary endpoint of latency to persistent sleep, or LPS, at Night 1 in 10 mg and 20 mg doses of Seltorexant. It also met its key secondary endpoint, defined as wake after sleep onset over first 6 hours at Night 1. The beneficial effects were maintained over time and were consistent in adults and elderly patients. “The findings from this study demonstrate that seltorexant significantly improves sleep induction and prolongs sleep duration,” said Professor Thomas Roth, Director of the Sleep Disorders and Research Center at Henry Ford Hospital. “The results also demonstrate that seltorexant showed a significantly greater improvement in these sleep parameters compared to zolpidem.” The study involved 365 patients with a mean age of 57.8, ranging from 22 to 84 years of age. Minerva shares have fallen 37.2% in 2019 through Friday, while the S&P 500 SPX, -0.02% has gained 17.7%.

FDA lifts partial hold on AbbVie’s study of venetoclax in multiple myeloma

The FDA has removed the partial clinical hold on AbbVie’s (NYSE:ABBV) Phase 3 clinical trial, CANOVA, evaluating the combination of Venclexta/Venclyxto (venetoclax) and dexamethasone versus Celgene’s (NASDAQ:CELG) Pomalyst (pomalidomide) + dexamethasone in patients with relapsed/refractory multiple myeloma (MM) who are positive for the translocation [t(11;14)] abnormality, a type of MM associated with a poor prognosis.
The agency removed the partial hold, which suspended patient recruitment but allowed continued treatment for currently enrolled participants, after the company revised the protocol, including new risk mitigation measures.
The FDA suspended enrollment in March in all venetoclax trials after reviewing data from the Phase 3 BELLINI study that showed a higher rate of deaths in the treatment group compared to control.
Shares are up a fraction premarket.

FDA accepts Glaxo’s application for expanded use of Zejula

GlaxoSmithKline (NYSE:GSKannounces that the FDA has accepted under Priority Review TESARO’s supplemental marketing application seeking approval to use Zejula (niraparib) to treat adult patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have received at least three prior lines of chemo, whose cancers are either BRCA-positive or homologous recombination deficiency-positive and have progressed more than six months after the most recent line of platinum-based chemo.
The agency’s action date is October 24.
The FDA approved Zejula in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemo.
Shares are up a fraction premarket.

Allergan Receives FDA Clearance For CoolTone™ Device

Allergan plc (NYSE: AGN) today announced CoolTone device received FDA clearance for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone is also indicated for strengthening, toning and firming of buttocks and thighs.

“As the global leader in medical aesthetics and body contouring, Allergan invests in the ongoing innovation and advancement of safe and effective non-surgical aesthetic solutions,” said Brad Hauser, Vice President, R&D and General Manager, Body Contouring, Allergan. “We do this by developing differentiated technology, such as the CoolTone device, that helps meet the needs of our customers.”
Using magnetic muscle stimulation (MMS), CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in improved muscle conditioning. Whether targeting abdomen, buttocks or thighs, CoolTone strengthens, tones and firms the muscles in the treated area, resulting in a more defined and toned appearance. CoolTone has 50 percent more magnetic intensity than the leading competitor (1.35 T versus 0.9 T) at the point of contact.* The clinical significance of this data has not been established.
“By partnering with Allergan, I can offer my patients additional options in body contouring solutions,” said Dr. Grant Stevens, Founder and Medical Director of Marina Plastic Surgery, Co-Founder and Chief Medical Officer of Orange Twist, and Chairman of the USC-Marina Aesthetic Surgery Fellowship. “CoolSculpting®, for non-surgical fat reduction, is one of the most requested treatments in my practice, and now I can introduce my patients to CoolTone for muscle toning, strengthening and firming of the abdomen, buttocks and thighs.”
Allergan is now taking orders for the CoolTone device, and first units will ship early in the fourth quarter of this year.

Concert Pharma started at Buy by SunTrust

Target $30