View Post

FDA Seeks Input On Patient Engagement In Clinical Trials

In Clinical Trials by Barbara Jacoby

Source: Nancy Crotti, MassDevice From: pharmavoice.com The FDA has released draft guidance on how medtech manufacturers should involve patients in the design and conduct of clinical trials. The agency’s Patient Engagement Advisory Committee (PEAC) recommended the FDA work with industry to develop a framework that clarifies how patient advisors can engage in the clinical investigation process. Patient advisors are defined …

View Post

Why the FDA Wants to Include Men in Breast Cancer Clinical Trials

In Clinical Trials by Barbara Jacoby

From: healthline.com The Food and Drug Administration is recommending that men be included in breast cancer treatment clinical trials. Men account for only 1 percent of breast cancer cases overall. Experts say it’s important to examine whether men respond differently to breast cancer treatment than women. The NATALEE clinical trial for breast cancer treatment is currently recruiting men. Men have …

View Post

Cancer accounts for more than one-quarter of new drug approvals, analysis finds

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com Overall, the report, from the Tufts Center for the Study of Drug Development, found that new cancer drug approvals since 2010 have increased by 4 percent since the 1980s. More than one-quarter of the drugs that have received Food and Drug Administration approval have been for cancers, according to a new analysis. The analysis, by …

View Post

FDA grants orphan drug designation to Nerlynx for breast cancer brain metastases

In In The News by Barbara Jacoby

Source: FDA News From: healio.com The FDA has granted neratinib orphan drug designation for the treatment of patients with breast cancer and brain metastases, according to a press release from the drug’s manufacturer. Neratinib (Nerlynx, Puma Biotechnology) — an irreversible pan-HER tyrosine kinase inhibitor — is approved for the extended adjuvant treatment of adults with HER2-overexpressed breast cancer, following adjuvant …

View Post

FDA Grants Breakthrough Device Designation to the Prescient Metabiomics LifeKit® Prevent Test for the Early Detection of Colon Polyps and Colon Cancer

In Clinical Trials by Barbara Jacoby

Source: Prescient Medicine From: PR Newswire Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation is the first designation for a non-invasive diagnostic test that is designed to …

View Post

Oncoceutics Announces FDA Acceptance of Investigational New Drug Application for Phase I Trial of ONC206

In Clinical Trials by Barbara Jacoby

Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201. The first clinical trial for ONC206 in adults …

View Post

COTA Signs Agreement with FDA for Breast Cancer Research

In Clinical Trials by Barbara Jacoby

By: Drew Boxler From: drugtopics.com COTA Inc, a precision medicine technology company that uses real-world evidence (RWE) to bring clarity to cancer care, has signed an agreement with FDA’s science and technology incubator, Information Exchange and Data Transformation Program (INFORMED). The agreement will bring real-world evidence to the development of breast cancer treatments. Under the two-year research collaboration agreement, COTA …

View Post

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

In Clinical Trials by Barbara Jacoby

From: fda.gov June 10, 2019 Today, 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. Polivy is a novel antibody-drug …

View Post

FDA Officials Call for Patient-Friendly Terminology in Oncology

In Clinical Trials by Barbara Jacoby

By: Michael Mezher  From: raps.org Officials from the US Food and Drug Administration’s (FDA) oncology offices say they plan to develop a glossary of patient-friendly terms and definitions for oncology clinical trial endpoints. In a paper published earlier this month in The Oncologist, officials from FDA’s Oncology Center of Excellence and Office of Hematology and Oncology Products make the case …

View Post

BioTheryX Announces FDA approval of IND Application to Initiate Phase I Clinical Trial in Relapsed or Refractory Acute Myeloid Leukemia

In Clinical Trials by Barbara Jacoby

Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019 BioTheryX, Inc. (“BioTheryX”), a biotechnology company creating new classes of drugs based on multi-kinase inhibition and targeted protein degradation, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared BioTheryX’s investigational new drug application (“IND”) for BTX-A51, an oral multi-kinase inhibitor, for the treatment …