ASCO shares the Administration’s goal of achieving lower drug costs but is concerned about some aspects of the proposal. ASCO is analyzing the proposal to determine the impact on patient care and practices. The society will respond to the Administration’s questions and request for feedback included in the proposed model to ensure that changes in […]
On October 31, CMS finalized significant changes to the Home Health Prospective Payment System (PPS) to strengthen and modernize Medicare. Specifically, CMS made changes to improve access to solutions via remote patient monitoring technology, updated payments for home health care with a new case-mix system, begin the new home infusion therapy benefit, and reduce burden. […]
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with […]
FDA Approves Expanded Label for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy for First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations Approval Based on Results of KEYNOTE-189, Where KEYTRUDA in Combination with Pemetrexed and Platinum Chemotherapy Reduced the Risk of Death by Half […]
The 2019 Medicare Physician Fee Schedule Proposed Rule with comment period was placed on display at the Federal Register on July 12, 2018. This proposed rule updates payment policies, payment rates, and other provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after Jan. 1, 2019. This proposed rule proposes potentially misvalued codes, […]
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer (BMS) Aug 17, 2018 – Bristol-Myers Squibb Company today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment […]
Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of castration-resistant prostate cancer (CRPC) patients.
U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi) Release Date: Friday, July 20, 2018 4:24 pm EDT Terms: Dateline City: NEW YORK NIVESTYM™, a biosimilar to Neupogen ® (filgrastim), is Pfizer’s fourth biosimilar to be approved by the FDA NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administ ration […]
Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the US FDA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed death ligand 1 (PD-L1) (combined positive score [CPS] ≥1) as determined by an FDA-approved test. This indication is approved […]
Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer • Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA mutation status – no biomarker testing required • Rubraca received regular approval in this […]
