News Service

late-breaking news in healthcare

EMA Reviewing Safety of Uptravi

February 21, 2017 News Service

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag, Actelion Pharmaceuticals), following reports of death in 5 patients taking the drug in France. Uptravi is indicated to treat adults with pulmonary arterial hypertension. It was approved by the EMA in May 2016, and by the food and Drug Administration (FDA) in December 2015.

FDA News Briefs for Monday, February 20, 2017

February 20, 2017 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA Approves Siliq for Psoriasis with Black Box Label Warning and REMS

February 17, 2017 News Service

On February 15, 2017, the Food and Drug Administration (FDA) approved Siliq (brodalumab; Valeant Pharmaceuticals) to treat adults with moderate-to-severe plaque psoriasis. The agency approved Siliq with a black box label warning on an observed risk for suicidal thoughts and actions. In addition, Siliq will be available only through a Risk Evaluation and Mitigation Strategy (REMS) program that will restrict access.  

Manufacturer Delays U.S. Launch of Drug for Duchenne Muscular Dystrophy

February 16, 2017 News Service

Marathon Pharmaceuticals announced on Monday that it is delaying the U.S. launch of Emflaza (deflazacort) in response to concerns from patients and lawmakers over the drug’s cost. The company did not state when it expected to make the drug commercially available.

New ACP Guideline Addresses Noninvasive Treatments for Low back Pain

February 15, 2017 News Service

The American College of Physicians (ACP) yesterday released a clinical practice guideline on noninvasive treatments for low back pain, including pharmacologic and nonpharmacologic options.

FDA Will Allow Sale of Novel Surgical Smoke Clearing Device

February 14, 2017 News Service

Alesi Surgical Limited announced last week that the Food and Drug Administration (FDA) has granted a de novo request for the Ultravision Visual Field Clearing System; a U.S. commercial launch date is pending.  

FDA News Briefs for Monday, February 13, 2017

February 13, 2017 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA Approves Novel Calcimimetic Drug for Adults On Hemodialysis

February 10, 2017 News Service

The Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide; Amgen), the first calcimimetic drug that can be administered intravenously at the end of a dialysis session.

ACIP Releases 2017 Recommended Immunization Schedules

February 9, 2017 News Service

The Advisory Committee on Immunization Practices (ACIP) has released 2017 immunization schedules for adults, children, and adolescents.  

AHA Statement on Management of NOAC Agents in Acute Care/Periprocedural Settings

February 8, 2017 News Service

The American Heart Association (AHA) has released a Scientific Statement on management of patients taking non-vitamin K antagonist oral anticoagulant (NOAC) agents in the acute care and periprocedural settings.