Monday, April 6, 2020

Monday, April 6, 2020

Latest News

FDA: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.

JANSSEN ONCOLOGY: Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting

TUBEROUS SCLEROSIS ALLIANCE: Lauds Lundbeck And FDA For Sabril Label Expansion For Patients 2 To 10 Years Old

On January 24, the Tuberous Sclerosis Alliance (TS Alliance) learned the US Food and Drug Administration (FDA) formally approved Lundbeck Pharmaceutical's label expansion for Sabril® (vigabatrin) to now be available to treat refractory complex partial seizures in patients 2 to 10 years old.

ABBOTT: Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease

Abbott's Infinity™ DBS is the first FDA approved directional Deep Brain Stimulation (DBS) system to allow targeting of a specific area of the brain that is critical to motor functions

INHIBITOR THERAPEUTICS: Receives prostate cancer IND Clearance from FDA

SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer

U.S. FDA: FDA approves first treatment for thyroid eye disease

U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).

OBI PHARMA: Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types

U.S. FDA: FDA approves new treatment for adults with migraine

The U.S. Food and Drug Administration approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.

EISAI INC.: U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients

Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients

U.S. FDA: FDA approves new type of therapy to treat advanced urothelial cancer

U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

U.S. FDA: FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

The U.S. Food and Drug Administration approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.

U.S. FDA: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

AMERICAN SOCIETY OF HEMATOLOGY: ASH and FDA Unveil New Recommendations to Guide Clinical Development of Sickle Cell Disease Therapies

Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies

FDA Health News