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Principia Biopharma’s PRN1008 gains FDA orphan drug status

American Pharmacy News Reports | Jul 25, 2017
Pemphigus vulgaris impacts approximately 40,000 individuals nationwide.

PRN1008 — acting as a reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor — has attained orphan drug designation by the U.S. Food and Drug Administration (FDA) for treating pemphigus vulgaris, its producer Principia Biopharma Inc. announced recently. Read More »

PrescribeCare cloud pharmacy service enters North Carolina

American Pharmacy News Reports | Jul 25, 2017
Hundreds of Community Care of North Carolina customers will have access to PrescribeWellness services.

Shifting from a “pill-centric to patient-centric” focus, cloud-based prescription service is now available for North Carolina consumers — enabling streamlined information sharing and care coordination — provider PrescribeWellness announced recently from its hub in Irvine, California. Read More »

GE Healthcare attains Novia Strategies to build capacity for improved outcomes

American Pharmacy News Reports | Jul 22, 2017
GE Healthcare Camden Group has served over 2,400 health care facilities and systems.

Joining forces with experienced clinicians from Novia Strategies, GE Healthcare recently acquired the 22-year-old California-founded consulting group to enhance its capability for driving optimal outcomes through organizational improvement. Read More »

GSK gears up for flu season with U.S. vaccine shipment

Carol Ostrow | Jul 22, 2017
As many as 40 million doses are predicted for shipping in anticipation of the next flu season.

GSK (GlaxoSmithKline PLC) recently commenced follow-up to approval gained from the U.S. Food and Drug Administration for shipping vaccines combating influenza to nationwide health care providers in advance of the 2017-18 flu season. Read More »

AmeriHealth Caritas Louisiana earns NCQA distinction

American Pharmacy News Reports | Jul 22, 2017
AmeriHealth Caritas Louisiana strives to serve all populations.

Demonstrating excellence in overcoming cultural barriers to quality care, Medicaid managed health care plan AmeriHealth Caritas Louisiana of Baton Rouge recently merited an honor from the National Committee for Quality Assurance (NCQA). Read More »

FDA approves Lannett's Cyproheptadine Hydrochloride Syrup

American Pharmacy News Reports | Jul 22, 2017
Cyproheptadine Hydrochloride Syrup acts as an antihistamine.

Lannett Company Inc. of Philadelphia recently obtained and subsequently announced FDA approval of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) in 2 mg/5 mL dosage form. Read More »

Magellan strikes deal to acquire Senior Whole Health

American Pharmacy News Reports | Jul 22, 2017
Magellan operates specialized managed care plans.

Magellan Health Inc. struck a deal this month to acquire Senior Whole Health, a provider of Medicare and Medicaid to dual-eligible clients in Massachusetts and New York. Read More »

Novoteris receives FDA approval to begin cystic fibrosis treatment

American Pharmacy News Reports | Jul 22, 2017
Novoteris is now recruiting subjects for the Phase 2 trial in cystic fibrosis research.

Novoteris LLC's Phase 2 clinical trial application for inhaled nitric oxide as a treatment for cystic fibrosis has been approved by both the U.S. Food and Drug Administration and the Therapeutic Products Directorate of Health Canada. Read More »

FDA reviews Pfizer's application for Sutent

American Pharmacy News Reports | Jul 22, 2017
Pfizer noted that a Type II Variation application for Sutent in the same patient population has been validated for review by the European Medicines Agency.

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for Sutent. Read More »

HedgePath Pharma seeks FDA guidance on its SUBA-Cap trial

American Pharmacy News Reports | Jul 21, 2017
Thirty-seven percent of patients in the Phase 2(b) trial have demonstrated an equal to or greater than 30 percent reduction in target tumor burden.

HedgePath Pharmaceuticals Inc. (HPPI) recently announced that the U.S. Food and Drug Administration (FDA) granted the company’s Type-C Guidance Meeting Request for further guidance on HPPI’s Phase 2(b) clinical trial analyzing SUBA-Itraconazole (SUBA-Cap) oral capsule usage in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. Read More »

Phase 3 trial shows Imbruvica benefits leukemia patients

American Pharmacy News Reports | Jul 21, 2017
Study results show continued survival rates in patients with chronic lymphocytic leukemia for up to four years.

AbbVie recently announced positive follow-up results for its pivotal Phase 3 Resonate trial, which evaluated Imbruvica as a treatment for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). Read More »

Amgen releases positive results for Xgeva Phase 3 study

American Pharmacy News Reports | Jul 21, 2017
Patients treated with Xgeva had fewer renal adverse events compared to those treated with zoledronic acid.

Amgen's Xgeva Phase 3 study, the largest international multiple myeloma trial ever conducted, met its primary endpoint by demonstrating that the drug is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. Read More »

Merck to partner with F-Star on bispecific immuno-oncology antibodies

American Pharmacy News Reports | Jul 21, 2017
Merck will be able to replace and add to these antibodies by using F-Star’s bispecific antibody platform.

Merck KGaA will collaborate with F-Star, a biopharmaceutical company in the United Kingdom, to develop and commercialize five bispecific immuno-oncology antibodies. Read More »

Amgen reports primary endpoint success for Phase 2 study

American Pharmacy News Reports | Jul 21, 2017
The combination more than doubled objective response rate in patients with unresectable Stage IIIB-IV melanoma.

Amgen's Phase 2 study evaluating Imlygic combined with Yervoy as a treatment for patients with unresectable Stage IIIB-IV met its​ primary endpoint. Read More »

West Pharmaceutical Services presents at InnoPack Pharma Confex

American Pharmacy News Reports | Jul 21, 2017
The presentation capped a weeklong series of seminars and educational activities.

West Pharmaceutical Services Inc. presented on best practices for improving patient outcomes through integrated containment and delivery systems at the Sixth Annual InnoPack Pharma Confex in Mumbai, India. Read More »

PCMA proposes policy to slash prescription prices

Carol Ostrow | Jul 19, 2017

Suggesting ways to reduce prescription drug costs plus overall marketplace guidance, the Pharmaceutical Care Management Association recently wrote to Health and Human Services Secretary Tom Price, detailing potential pricing and savings allocation improvements. Read More »

Sanofi, Regeneron release positive results for carcinoma inhibitor

American Pharmacy News Reports | Jul 19, 2017
REGN2810 is also being evaluated in a Phase 2 study.

Sanofi and Regeneron Pharmaceuticals Inc. recently announced positive results for a Phase 1 study evaluating investigational REGN2810, a checkpoint inhibitor targeting PD-1 (programmed death 1) in patients with advanced cutaneous squamous cell carcinoma. Read More »

Elsevier’s ‘Hive’ 2017 to feature biotech, pharma startups

American Pharmacy News Reports | Jul 19, 2017
Pre-revenue biotech, pharma and other small companies involved in early stage research with at least 10 scientists on staff are eligible.

Specialists at information analytics company Elsevier recently announced that its 2017 season for “The Hive,” its source for rising biotech and pharmaceutical companies, is gearing up with unlimited nomination spots now open for aspiring entrants. Read More »

Bill to regulate pharmacy benefit managers advances in California

John Breslin | Jul 19, 2017
The California bill requires PBMs to annually obtain a license from the Department of Managed Health Care.

A bill mandating pharmacy benefit managers obtain a license to conduct business in California and release information to health plans and other purchasers is moving through the state's legislature. Read More »

Rennova Health to spin off AMSG division to public ownership

American Pharmacy News Reports | Jul 19, 2017
Rennova’s board of directors previously authorized a spinoff of its Health Technology Solutions business.

Via tax-free allotment to company shareholders, Rennova Health Inc. intends to transition its Advanced Molecular Services Group to a publicly traded entity by late September pending appropriate paperwork with the SEC and other conditions. Read More »

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