Sunday, February 23, 2020

Sunday, February 23, 2020

Latest News

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

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.

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).

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.

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.

JANSSEN PHARMACEUTICAL: U.S. FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD

INVOKANA® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD

Xarelto proven to reduce blood clots and medical costs for morbidly obese patients

Xarelto has proved to reduce the risk of recurrent venous thromboembolism (VTE), blood clots, in patients who are also suffering from morbid obesity.

Bongo Rx may replace the CPAP for treatment of mild to moderate sleep apnea

More than 70 percent of 200 patients with mild to moderate sleep apnea participating in a Qualtrics Survey conducted September 4 though September 11 selected the FDA-approved Bongo Rx as their preferred choice over a traditional CPAP.

GENETECH: FDA Approves Genentech’s Rituxan (rituximab) in Children With Two Rare Blood Vessel Disorders

Rituxan is the first and only FDA-approved treatment for pediatric patients 2 years of age and older living with granulomatosis with polyangiitis or microscopic polyangiitis

U.S. FDA: Approves first treatment for children with rare diseases that cause inflammation of small blood vessels

The U.S. Food and Drug Administration today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones).

FDA taken to task over opioid approval process

Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.

ABIOMED: Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump

Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.

PHARMACEUTICS INTERNATIONAL, INC.: Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product

Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the commercial supply of Fulvestrant Injection 250mg/5ml drug product, which was recently approved by the FDA.

V-Wave heart treatment receives manufacturer's second FDA Breakthrough Device Designation

The U.S. Food and Drug Administration (FDA) recently awarded a second Breakthrough Device Designation for V-Wave Ltd.’s interatrial shunt for pulmonary arterial hypertension (PAH).

Peanut allergy treatment moves closer to FDA approval

A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.

U.S. FDA: Approves first oral GLP-1 treatment for type 2 diabetes

The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.

FDA Health News