Monday, March 30, 2020

Monday, March 30, 2020

Latest News

FDA approves $2.1 million drug, opens door for more gene therapy

The U.S. Food and Drug Administration recently approved a drug that costs $2.1 million and it’s a potential cure for a childhood disorder that afflicts children under 2 years of age.

U.S. FOOD AND DRUG ADMINISTRATION: FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

The U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

The U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.

NOUSCOM: IND for NOUS-209, an 'off-the-shelf' Neoantigen Cancer Vaccine, Cleared by FDA to Commence Clinical Development in MSI Solid Tumors

Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced that its Investigational New Drug (IND) application for the first clinical trial of its lead candidate NOUS-209 has been cleared by the US Food and Drug Administration (FDA).

ELI AND LILLY COMPANY: U.S. FDA Accepts New Drug Application for Triple Combination Tablet for Adults with Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Curio Wellness wants cannabis to be regulated under Federal Food, Drug and Cosmetic Act

Curio Wellness, the market-leading medicinal cannabis company in Maryland, presented a scientifically grounded, patient-focused perspective to de-schedule cannabis and have it regulated under the Food and Drug Administration’s Federal Food, Drug, and Costmetic Act.

Learning Tree International and Suntiva partner to support FDA Integrated Services BPA

A five-year base contract worth an estimated $100 million between Learning Tree International and Suntiva will help support the Food and Drug Administration (FDA) Integrated Services Blanket Purchase Agreement (BPA).

BIOSIGHT, LTD: Receives Orphan Drug Designation From the FDA for BST-236 for the Treatment of Acute Myeloid Leukemia

Biosight Ltd., a pharmaceutical development company focused on the development of novel oncology therapeutics, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to BST-236, an investigational novel antimetabolite, for the treatment of acute myeloid leukemia (AML).

ELI AND LILLY COMPANY: FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks

With this approval, Emgality is the only calcitonin gene-related peptide (CGRP) antibody indicated for the preventive treatment of migraine and the treatment of episodic cluster headache

New added sugar labeling policy could be sweet news for FDA, consumers

The Food and Drug Administration's (FDA) recently announced a mandatory added sugar labeling policy for packaged foods and beverages, set to take effect between 2020 and 2021.

VIVACELLE BIO, INC.: Announces Submission of an IND Application with U.S. FDA for VBI-S, an Injectable Fluid for the Treatment of Patients with Severe Septic Shock

Vivacelle Bio, Inc. announced that it supported an investigational new drug (IND) application to the U.S. Food & Drug Administration for a phase IIa clinical trial of VBI-S, a phospholipid-based nanoparticle fluid that has the potential to elevate the blood pressure of patients who are suffering severe septic shock.

5 drugs recalled during May, FDA reports

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.

ORION BIOTECHNOLOGY: Announces Receipt of Pre-IND Guidance From the United States FDA on the Further Development of OB-002O as a Potential Treatment for Solid Tumors

Orion Biotechnology Canada Ltd., announced that it has received feedback from the Food and Drug Administration (FDA) on a Pre-Investigational New Drug (PIND) application which was submitted in March 2019.

KIT CHECK: Brings Next-Generation Medication Tracking Mainstream with FDA Pilot

Pilot looks to implement tech that improves the tracking of powerful drugs and interoperability of software throughout the supply chain

SPEEDX: Receives FDA Breakthrough Designation for ResistancePlus® GC

New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment

FDA should 'err on the side of caution' with forever chemicals

A public health watch dog warns that the presence of “forever chemicals” in foods recently tested by the Food and Drug Administration should be treated with alarm.

FDA Health News