National Association of Realtors Amicus Brief Defends DOL on Health Plan Rule

Five local Realtor® associations currently offering Association Health Plans sign onto NAR Effort

The National Association of Realtors® filed an amicus brief in defense of the Department of Labor’s (DOL) Association Health Plan rule late last week. Amicus briefs are legal documents filed in appellate court cases by non-litigants that have a strong interest in the subject matter in question. Earlier this year, a federal court ruled that provisions of the DOL’s rule were unlawful, a ruling adversely impacting Realtors® seeking more cost effective and comprehensive health insurance solutions through AHP options. The Department of Justice is appealing the ruling and NAR’s amicus brief submission supports the DOJ’s appeal.

“Passage of the Patient Protection and Affordable Care Act resulted in significant regulatory changes to the individual insurance market, some of which have benefited Realtors®,” the brief reads. “However, ACA changes have also resulted in significant increases in health care costs, leaving many individuals to forgo coverage, which jeopardizes the health, safety and financial stability of their families and others.”

https://www.streetinsider.com/Press+Releases/National+Association+of+Realtors%C2%AE+Files+Amicus+Brief+Defending+Labor+Departments+AHP+Rule/15596863.html

Ligand Pharma (LGND) PT Lowered to $140 at Argus

Weakness Offers Buying Opportunity: analyst Jasper Hellweg

https://www.streetinsider.com/Analyst+Comments/Ligand+Pharma+%28LGND%29+PT+Lowered+to+%24140+at+Argus%2C+Weakness+Offers+Buying+Opportunity/15596431.html

FDA OKs expanded use for Masimo’s O3 oximeter

The FDA grants 510(k) clearance for Masimo’s (MASI +4%) O3 Regional Oximetry for use on neonatal and infant patients (less than 10 kg). It was previously cleared for adult and pediatric patients.

https://seekingalpha.com/news/3470196-fda-oks-expanded-use-masimos-o3-oximeter-shares-4-percent

Tetraphase up on retrospective Xerava data

Nano cap Tetraphase Pharmaceuticals (TTPH +11%) is up on below-average volume in response to results from three studies that support the value proposition of antibiotic XERAVA (eravacycline), approved in the U.S. in April 2018 for the treatment of complicated intra-abdominal infections (cIAIs). The data were presented at the Surgical Infection Society Annual Meeting in Coronado, CA.

A post hoc analysis of the Phase 3 INGITE1 and IGNITE4 trials showed a clinical cure rate of 89.0% versus 88.6% for comparators in patients with complicated appendicitis. The respective cure rates were 88.8% and 89.7% in patients with cIAIs not associated with appendicitis.

To better understand the outcomes of hospitalization for cIAIs, a retrospective cohort study from ~180 hospitals involving 4,453 patients with cIAIs and positive cultures was conducted, showing a 7.6% resistance rate to third-generation cephalosporins. The mortality rate from cIAIs was 7.6%, but jumped to 11.2% in patients who were readmitted within 30 days of discharge.

https://seekingalpha.com/news/3470207-tetraphase-11-percent-retrospective-xerava-data

Valeritas up on positive V-Go data

Valeritas Holdings (VLRX +4.6%) is up on average volume on the heels of new data on its V-Go Wearable Insulin Delivery device. The results were presented at the American Diabetes Association Scientific Sessions in San Francisco.

Patients with type 2 diabetes (T2D) who switched to V-Go from a basal regimen for their insulin therapy experienced lower HbA1C levels without increasing their daily dose of insulin.

The retrospective analysis of 73 patients showed an average HbA1C reduction of -1.3 with 16% fewer accompanying prescribed medications. The incidence of hypoglycemia (low blood sugar) dropped to 19% from 23%.

https://seekingalpha.com/news/3470216-valeritas-5-percent-positive-v-go-data

FDA grants accelerated review status for Roche’s Polivy

Roche’s (OTCQX:RHHBY +0.2%) Genentech unit announces accelerated review status in the U.S. for antibody-drug conjugate Polivy (polatuzumab vedotin-piiq), combined with chemo agent bendamustine [Teva’s (TEVA+2.2%) Bendeka] and Rituxan (rituximab), for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies.

Polivy targets a protein expressed in most B cells called CD79b. Polatuzumab binds to CD79b thereby delivering the cytotoxic agent directly to the B cell.

The company’s marketing application is currently under FDA review with an action date of August 19.

https://seekingalpha.com/news/3470185-fda-grants-accelerated-review-status-roches-polivy-dlbcl

Seattle Genetics’ Antibody-Drug Conjugate Tech Used in FDA OK

Approval Triggers Milestone Payment and Royalties on Worldwide Net Sales-

Seattle Genetics, Inc. (SGEN) today announced U.S. Food and Drug Administration (FDA) approval of Polivy™ (polatuzumab vedotin-piiq), which is an antibody-drug conjugate (ADC) targeting CD79b that utilizes Seattle Genetics’ technology. Polivy was developed and will be commercialized by Genentech, a member of the Roche Group. It was approved in combination with bendamustine plus Rituxan^® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Polivy previously received FDA Breakthrough Therapy Designation, and was approved more than two months ahead of the Prescription Drug User Fee Act (PDUFA) action date of August 19, 2019.

https://finance.yahoo.com/news/seattle-genetics-antibody-drug-conjugate-165100975.html