Entries by Karim Bandealy

FDA Approves Amgen’s PCSK9 Drug Repatha

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy […]

Amgen Files for FDA Approval of its Secondary Hyperparathyroidism Drug

THOUSAND OAKS, Calif., Aug. 25, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will […]

First Patient Enrolled in CSL Behring’s On-Demand Treatment for Patients with Hemophilia A or B with Inhibitors

KING OF PRUSSIA, Pa. — 25 August 2015 Key milestone achieved in CSL Behring’s PROLONG-7FP clinical development program PROLONG-7FP is studying CSL Behring’s recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) Milestone underscores CSL Behring’s focused scientific expertise and deep commitment to developing and delivering innovative specialty biotherapies for people with serious diseases […]

Banner MD Anderson to Test New Drug for Late-Stage Pancreatic Cancer

GILBERT, AZ – A new clinical trial at Banner MD Anderson Cancer Center aims to test a new treatment to fight late-stage pancreatic cancer, one of the nation’s deadliest cancers. About 73 percent of patients with pancreatic cancer die in the first year of diagnosis, according to the American Cancer Society. The drug known as […]

Eighty Percent of Physicians Want More Education on Biosimilars

WALTHAM, Mass.–(BUSINESS WIRE)–Quantia, Inc.—the platform for Physician Engagement—today announced key findings from its new report, “Reading the Signs: A Roadmap for Increasing Physician Engagement in the Biosimilars Market.” The report examines healthcare professionals’ awareness of biosimilar drugs, potential barriers to adoption, and opportunities to provide education that may drive prescribing decisions. Key findings from this […]

FDA Expands Approval of Seattle Genetics’ Adcetris

BOTHELL, Wash.–(BUSINESS WIRE)–Aug. 17, 2015– Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The approval is based on […]

Merck Enhances Immuno-Oncology Portfolio with Acquisition of cCAM Biotherapeutics

KENILWORTH, N.J. & MISGAV, Israel–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and cCAM Biotherapeutics announced today that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the […]

SANOFI AND REGENERON ANNOUNCE FDA APPROVAL OF PRALUENT® (ALIROCUMAB) INJECTION, THE FIRST PCSK9 INHIBITOR IN THE U.S., FOR THE TREATMENT OF HIGH LDL CHOLESTEROL IN ADULT PATIENTS

PARIS and TARRYTOWN, N.Y., July 24, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and […]

FDA approves new treatment for chronic hepatitis C genotype 3 infections

The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to […]

Patient Access Network Foundation Launches New Online Patient Portal

Washington, DC – The Patient Access Network (PAN) Foundation today announced the launch of a new online patient portal that expedites its financial assistance application process and allows for real-time determination of eligible patients with critical and chronic illnesses. The new patient portal complements PAN’s existing specialty pharmacy and provider portals, streamlining the financial assistance application […]