Wednesday, April 8, 2020

Wednesday, April 8, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

U.S. District Judge Ursula Ungaro of the Southern District of Florida issued an order that stops US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

The U.S. Food and Drug Administration approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.

FDA warns of infection risk from fecal microbiota transplants

Patients who receive fecal microbiota for transplant (FMT) are at risk of life-threatening infections, the Food and Drug Administration said.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication to use, if any, for a particular patient is often a complex decision.

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

The U.S. Food and Drug Administration is providing an update on its investigation into reports of dilated cardiomyopathy (DCM) in dogs eating certain types of pet food.

PUMA BIOTECHNOLOGY: Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).

PERRIGO COMPANY PLC: Perrigo Announces FDA Final Approval and Launch Of The AB-rated Generic Version Of Metrogel-Vaginal® Gel

Perrigo Company plc (NYSE; TASE: PRGO) announced its product development partner received final approval from the U.S. Food and Drug Administration for its AB-rated Abbreviated New Drug Application ("ANDA") referencing Metrogel-Vaginal® (metronidazole vaginal gel 0.75%).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for refractory multiple myeloma

The U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

6 drugs recalled during June, FDA reports

Six drugs were recalled in June to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.

INSYS THERAPEUTICS, INC: FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose

INSYS Therapeutics, Inc. (OTCMKTS: INSYQ), announced that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing.

Cybersecurity issues lead to recall of some Medtronic insulin pumps

Medtronic MiniMed 508 and MiniMed Paradigm series insulin pumps are being recalled because of cybersecurity concerns, according to the Food and Drug Administration.

BIOTRONIK: Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III

Device is 60% Smaller, Offers Simplified One-Step Injection Procedure and Sets New Standard for Signal Quality

FDA panel: more research needed on potentially negative effects associated with paclitaxel-coated device treatment

While the long-term effects of treatment with paclitaxel-coated devices in the peripherals are still unclear, the U.S. Food and Drug Administration could not rule out an association with adverse effects, even at very low drug concentrations.

Daiichi Sankyo issues update on new cancer drug

Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.

Electronic skin patch companies grapple with changing reimbursement schemes, report says

Ever-changing reimbursement schemes are forcing firms involved in electronic skin patches to lobby and adapt or leave the sector altogether, a research report surveying the product category said.

MERCK: FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option.

CONTIPI MEDICAL LTD: Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women

This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder).

AZURITY PHARMACEUTICALS: FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older

Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.

FDA Health News