Tuesday, December 10, 2019

Tuesday, December 10, 2019

Latest News

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.

EPICA INTERNATIONAL, INC.: Announces U.S. FDA 510(k) Clearance for its Multi-modality, Mobile Computed Tomography Imaging Platform, SeeFactorCT3™

Epica International, Inc. (Epica), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SeeFactorCT3™ Imaging Platform. SeeFactorCT3™ consists of 3 integrated imaging systems: CT, Fluoroscopy and Digital Radiography; a detachable patient table/chair, and sterile drape for interventional procedures. FDA clearance allows Epica to market these products in the United States.

Lilly announces successful clinical trial for thyroid cancer treatment LOXO-292

Eli Lilly and Company recently announced that results of the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.

Novartis' Kisqali demonstrates improvement in overall survival in MONALEESA-3 trial

Novartis recently reported results from the MONALEESA-3 trial, the largest to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726), which showed that CDK4/6 inhibitor Kisqali (ribociclib) demonstrated statistically significant improvement in overall survival (OS).

FDA plans 19 public meetings in October

Nineteen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for October, the FDA reported.

PUMA BIOTECHNOLOGY: FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

BIOFOURMIS: Biofourmis' Biovitals™ Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring

Milestone approval establishes AI-powered solution as the foundation for future disease-specific predictive management tools from Biofourmis

PACIFIC KETAMINE INSTITUTE: Introduces SPRAVATO™ Treatment for Depression and Mental Disorders

Pacific Ketamine Institute (PKI), a pioneer in treating depression, PTSD, and chronic pain using Ketamine-based treatments, announced today that it has officially started offering patients the new FDA-approved esketamine nasal spray, SPRAVATO™, at its flagship Beverly Hills treatment center.

JANSSEN: Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects

AMERICA'S BLOOD CENTERS: Urges FDA to Continue to Evaluate Impact of New Final Guidance on Platelet Availability

America's Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry.

U.S. FDA: Approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

The U.S. Food and Drug Administration approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.

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).

NOVARTIS: Receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

Novartis today announced that the U.S. Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)

DEXCOM: Announces FDA Clearance of New Dexcom G6 Pro CGM

First and only single-use, professional CGM system with blinded or unblinded mode

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.

OCTAPHARMA USA: FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients

Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.

FDA grants marketing approval for Australian product that treats rare skin disease

The U.S. Food and Drug Administration (FDA) recently granted marketing approval to use Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Vitosa stevia sweetener receives 'Letter of No Objection' from the FDA

HB Natural Ingredients has received a "Letter of No Objection" for Vitosa stevia sweeteners from the U.S. Food and Drug Administration (FDA), confirming that the agency has "no questions" on the self-affirmed GRAS (generally recognized as safe) status of Vitosa for use as a sweetener in food and beverage products.

FDA Health News