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Intensity Therapeutics Receives Fast Track Designation from U.S. FDA for Development of INT230-6 as Treatment for Relapsed or Metastatic Triple Negative Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: Intensity Therapeutics Inc From: globenewswire.com Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed …

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Are You Dense?

In In The News by Barbara Jacoby

By: Bonnie Annis From: curetoday.com Are you dense? I’m not referring to your mental abilities, I’m referring to your breasts. Have you felt them lately? I’m very concerned with your answer and so is the Food and Drug Administration (FDA), it seems. For the first time in over 20 years, the FDA feels amendments to current regulations would not only improve …

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Novel Agent Granted Orphan Drug Designation for T-Cell Prolymphocytic Leukemia

In Clinical Trials by Barbara Jacoby

By: Audrey Sternberg From: targetedonc.com Investigational agent tinostamustine (EDO-S101), a first-in-class alkylating deacetylase inhibiting molecule, has been granted orphan drug designation by the FDA for the treatment of patients with T-cell prolymphocytic leukemia (T-PLL).1 “This orphan drug designation represents an important step…for patients suffering from T-PLL who do not currently have sufficient treatment options,” said Richard Fanelli, PhD, head of …

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FDA suggests letting more patients with viral infections into cancer clinical trials

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com A draft guidance, not yet implemented, suggests allowing more patients with hepatitis B and C and HIV into oncology clinical trials from which they are currently excluded. On the pages of oncology clinical trials on the database ClinicalTrials.gov, the section listing the various criteria that patients must meet for enrollment commonly includes a line stating …

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Why Do We Need a Right-to-Try Bill in America?

In In The News by Barbara Jacoby

By: Jane M. Orient, M.D. Congress recently passed, and President Trump signed, the “Right to Try” bill that gives dying patients limited access to drugs that have not yet been approved by the Food and Drug Administration (FDA). Our Founders would be astonished that we need such a bill. Nowhere does the U.S. Constitution give the federal government the authority …

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FDA chief outlines new ways to speed cancer drug approvals

In In The News by Barbara Jacoby

By: Julie Steenhuysen From: reuters.com The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. The new approach, outlined on Saturday in a speech by FDA commissioner Dr. Scott Gottlieb at the American Society of Clinical Oncology (ASCO) meeting in …

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Pot Doesn’t Cure Cancer and Stop Saying it Does, FDA Says

In In The News by Barbara Jacoby

By: Maggie Fox From: nbcnews.com Marijuana doesn’t cure cancer. It has not been shown to somehow explode tumor cells or promote the growth of new brain cells, the Food and Drug Administration said Wednesday. The FDA warned four companies to stop making these unproven claims and to stop selling cannabis-based hemp and marijuana products that claim to treat cancer or …

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Toledo cancer clinic offers hair loss prevention

In In The News by Barbara Jacoby

By: DR. TIMOTHY KASUNIC From: toledoblade.com After decades of research and development, finally, many cancer patients undergoing chemotherapy will be able to avoid its most emotionally dreaded complication: complete hair loss. The U.S. Food and Drug Administration cleared the Dignicap System as the first scalp cooling system to prevent chemotherapy-related hair loss in breast cancer patients, in December, 2015. Toledo …

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Actinium Receives Orphan Drug Designation From FDA for Iomab-B

In In The News by Barbara Jacoby

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred …

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Bladder Cancer Breakthrough Treatment Developed after 30 Years

In In The News by Barbara Jacoby

A much-awaited breakthrough in the treatment for advanced bladder cancer has been made by scientists from the Barts Cancer Institute of Queen Mary University of London. The breakthrough, which is the first major advancement in the treatment of the dreaded disease over the past 30 years, is detailed in a paper published in the Nature journal. The research studied MPDL3280A, an …