Monday, December 9, 2019

Monday, December 9, 2019

Latest News

DisposeRx helps to eradicate millions of opioid pills

Fulfilling its pledge to remove millions of opioid pills from the medicine cabinets of American homes, DisposeRx recently donated over 150,000 packets of its non-toxic, safe solution for the disposal of unused or expired medications to 140 community partners in 43 states through its community outreach program.

BERGENBIO ASA: Receives FDA Approval of Fast Track Designation for Bemcentinib

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.

Hackensack Meridian Health launches $1 million 'Take Vape Away' campaign

Hackensack Meridian Health has invested $1 million in a comprehensive strategy to curb the vaping epidemic through its "Take Vape Away" campaign.

BOEHRINGER INGELHEIM: FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

The designation was supported by results from the Phase III INBUILD® study that met its primary endpoint and was recently published in the New England Journal of Medicine

EICOSIS: Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain

EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.

Washington Policy Center analyst says black-market THC products to blame for vaping deaths, illnesses

As Congress criticizes the Food and Drug Administration (FDA) for its 2017 delay of reviewing e-cigarettes and vaping products, and blames the agency for the current vaping-illness outbreak across the U.S., Washington Policy Center Health Care Policy Analyst Roger Stark, M.D., is stressing to the nation that the FDA should not be held responsible for the recent surge in health emergencies.

JANSSEN: Submits Application to U.S. FDA Seeking Approval of STELARA®(ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO).

HERON THERAPEUTICS: Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.

U.S. FDA: Approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks

The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

U.S. FDA: Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications.

RENEO PHARMACEUTICALS: FDA Grants Orphan Drug Designation to Reneo Pharmaceuticals for REN001 for Treatment of Fatty Acid Oxidation Disorders

Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).

SOUND PHARMACEUTICALS: FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease

Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).

GALA THERAPEUTICS: Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOxTM Bronchial RheoplastyTM system.

DREAMED DIABETES: New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy Across All Glucose Measurement Methods

DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology

FDA Health News