From: media@thenewswire.com There is mounting evidence from many sources about mammography being an inferior method for identifying or helping in the diagnosis of suspicious breast lesions that may be cancer. Some informed sources say mammography is completely unnecessary, and others go as far to say that mammography causes more harm than good. Regardless, mammography is the current gold standard …
Cytotron® Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers
Source: Shreis Scalene Sciences From: prnewswire.com The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON® – a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of …
FDA Seeks Input On Patient Engagement In Clinical Trials
Source: Nancy Crotti, MassDevice From: pharmavoice.com The FDA has released draft guidance on how medtech manufacturers should involve patients in the design and conduct of clinical trials.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 …
Why the FDA Wants to Include Men in Breast Cancer Clinical Trials
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 …
Cancer accounts for more than one-quarter of new drug approvals, analysis finds
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 …
FDA grants orphan drug designation to Nerlynx for breast cancer brain metastases
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 …
FDA Grants Breakthrough Device Designation to the Prescient Metabiomics LifeKit® Prevent Test for the Early Detection of Colon Polyps and Colon Cancer
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 …
Oncoceutics Announces FDA Acceptance of Investigational New Drug Application for Phase I Trial of ONC206
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 …
COTA Signs Agreement with FDA for Breast Cancer Research
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 …
FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma
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 …