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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 …

FDA To Regulate Thousands Of Cancer, Genetic, And Other Diagnostics

In In The News by Barbara Jacoby

By: Matthew Herper From: forbes.com The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye. More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory …

Trials let more patients get ‘breakthrough’ cancer therapies closer to home

In In The News by Barbara Jacoby

By: Liv Osby From: greenvilleonline.com Rhonda McNeely will never forget that November day she had to tell her children she had advanced cancer. “When you have to come home and tell your daughters that you have cancer,” she said, “the looks in their eyes … it was a very sobering thing for all of us.” If there was any ray …

Amgen colorectal cancer drug gains U.S. approval for wider use

In In The News by Barbara Jacoby

By: By Alex Wayne, Bloomberg News From: chicagotribune.com Amgen Inc. won expanded U.S. approval for its drug Vectibix as an initial treatment in patients with a type of advanced colorectal cancer who first undergo genetic screening. The drug was cleared by the Food and Drug Administration as an initial treatment in conjunction with chemotherapy for patients whose tumors have a …