Exelixis’ Kidney Cancer Drug Cabometyx Positive in Phase II

Exelixis, Inc. (EXELAnalyst Report) announced positive top-line data from the phase II trial, CABOSUN, on Cabometyx in patients suffering from previously untreated advanced renal cell carcinoma (RCC).

Results showed that Cabometyx led to significant improvement in progression-free survival in patients with previously untreated advanced RCC, compared with sunitinib. Consequently, the trial met its primary endpoint.

Safety data from the Cabometyx arm of the study were consistent with those observed in previous studies in patients with advanced RCC.

Final results of the trial will be presented at a medical conference shortly.

We remind investors that Cabometyx (the tablet formulation of cabozantinib) was approved by the FDA in Apr 2016 for the treatment of patients with advanced RCC, who have received prior anti-angiogenic therapy.

Meanwhile, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Cabometyx for review in the same indication. Upon a potential approval, the drug would be marketed in the EU by Exelixis’ partner, Ipsen. The MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which translates a review period of 150 days instead of the standard 210 days.

Exelixis also plans to submit results of the CABOSUN trial to regulatory authorities in order to discuss further development of Cabometyx and submission strategy for the treatment of first-line advanced RCC.

As per the American Cancer Society, kidney cancer is one of the top 10 most commonly diagnosed forms of cancer in both men and women in the U.S. Hence, approval of Cabometyx in first-line advanced RCC will boost its growth prospects significantly.

Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT – Analyst Report) , Johnson & Johnson (JNJ – Analyst Report) and Sanofi (SNY – Analyst Report) . All three stocks carry a Zacks Rank #2 (Buy).

From https://www.zacks.com/stock/news/218403/exelixis-kidney-cancer-drug-cabometyx-positive-in-phase-ii

Miniature Portable Dialysis Machine on Fast Track for FDA Approval

I sure hope I never need this but…

 

An Alternative to Conventional DialysisThe US Food & Drug Administration’s (FDA) fasttrack program, Innovation Pathway, streamlines the approval process for breakthrough technologies.

In 2012, the “Wearable Artificial Kidney” (WAK), promoted by the Wearable Artificial Kidney Foundation, Inc., was awarded fast-track status, along with two other renal projects.

Since then, WAK has made progress with its wearable dialysis machine and is currently involved in animal trials; human trials scheduled for 2017.

The current prototype weighs just 10 pounds and can be carried about the waist of the patient. Another company, AWAK Technologies, has developed a WAK for Peritoneal Dialysis called “ViWAK PD” that weighs just two pounds.

Source: Miniature Portable Dialysis Machine on Fast Track for FDA Approval | Health Cure Center

It’s Fruit and Veggie Season Again :)

hippocratesfoodquote

 

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year, and some of the causes might surprise you.

Although most people know animal products must be handled carefully to prevent illness, many don’t realize that produce can also be the culprit in outbreaks of foodborne illness. In recent years, the United States has had several large outbreaks of illness caused by contaminated fruits and vegetables—including spinach, tomatoes, and lettuce.

Glenda Lewis, an expert on foodborne illness with the Food and Drug Administration, says fresh produce can become contaminated in many ways. During the growing phase, fruits and veggies may be contaminated by animals, harmful substances in the soil or water, and poor hygiene among workers. After produce is harvested, it passes through many hands, increasing the contamination risk. Contamination can even occur after the produce has been purchased, during food preparation, or through inadequate storage.

FDA says to choose produce that isn’t bruised or damaged, and make sure that pre-cut items—such as bags of lettuce or watermelon slices—are either refrigerated or on ice both in the store and at home. In addition, follow these recommendations:

  • Wash your hands for 20 seconds with warm water and soap before and after preparing fresh produce.
  • Cut away any damaged or bruised areas before preparing or eating.
  • Gently rub produce while holding under plain running water. There’s no need to use soap or a produce wash.
  • Wash produce BEFORE you peel it, so dirt and bacteria aren’t transferred from the knife onto the fruit or vegetable.
  • Use a clean vegetable brush to scrub firm produce, such as melons and cucumbers.
  • Dry produce with a clean cloth or paper towel to further reduce bacteria that may be present.
  • Throw away the outermost leaves of a head of lettuce or cabbage.

 

Lewis says consumers should store perishable produce in the refrigerator at 40 degrees or below.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.