FDA reviews Pfizer's application for Sutent
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
Chronic hepatitis C virus (HCV) patients have a new treatment option with the approval of Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the U.S. Food and Drug Administration. Read More »
Launching a four-year research program to develop diabetes and obesity treatments, PreveCeutical Medical Inc. of Vancouver, British Columbia recently signed an agreement with UniQuest Pty Ltd. of the University of Queensland in Australia. Read More »
Amgen of Thousand Oaks, California and Array BioPharma of Boulder, Colorado recently created a cooperative contract to develop innovative drugs aimed at combating autoimmune disorders after Array’s breakthrough discovery of certain target and lead inhibitors. Read More »
Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt has written directly to U.S. Food and Drug Administration Commissioner Scott Gottlieb to offer the association’s concise solution for fast-tracking “common-sense” improvements to the nation’s opioid abuse policy. Read More »
The last patient in the Phase II BEKINDA (RBH-102) study has completed the treatment and follow-up, RedHill Biopharma Ltd. announced on Monday. Read More »
Test detects five most commonly misused and abused prescription drugs; five-minute results will facilitate rapid interventions in prescription drug abuse. Read More »
Agricultural technology firm Arcadia Biosciences Inc. has successfully attained an Early Food Safety Evaluation from the U.S. Food and Drug Administration determining that its functional protein product is safe for humans and animals. Read More »
Optum, UnitedHealth Group’s health services business, and Merck recently announced collaboration on developing and simulating the performance of contractual reimbursement models that align payment for prescription drugs with patient health outcomes. Read More »
Novartis' Zykadia, a treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, has been approved for expanded use by the U.S. Food and Drug Administration. Read More »
EMD Serono, the biopharmaceutical business of Merck KGaA in the United States and Canada, recently showcased 14 presentations at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers, including eight sets of data on Cladribine Tablet, a treatment for patients with relapsing multiple sclerosis. Read More »
Pfizer Inc.'s proposed epoetin alfa biosimilar has been recommended for approval across all indications by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee. Read More »