Benznidazole is an essential medicine for Chagas disease, a dangerous parasitic disease that affects an estimated 6 to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.
The U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.nBenznidazole is an essential medicine for Chagas disease, a dangerous parasitic disease that affects an estimated 6 to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.
Marking a dramatic step for a partnership aiming to affordably treat Chagas patients, the FDA approved the group's antiparasitic treatment benznidazole. But the approval is an equally dramatic setback for Humanigen, a company once run by infamous pharma executive Martin Shkreli—and that drugmaker may have Shkreli himself to thank for its loss.
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Bristol-Myers Squibb (BMS0 has announced that the National Institute for Health and Care Excellence (NICE) has issued draft guidance for consultation that could prevent NHS patients with a form of lung cancer, from receiving Opdivo (nivolumab). The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung (NSCLC) whose disease has progressed after prior chemotherapy. In a pivotal clinical study, treatment with nivolumab was shown to achieve significantly superior survival rates, with 42% of patients still alive at one year compared with 24% of those treated with docetaxel. If this becomes final guidance, it will mean that treatment options for these patients will remain limited to chemotherapies, such as docetaxel which was first approved for use 17 years ago. Lung cancer is one of the UK’s biggest health challenges, with survival rates that lag almost a decade behind some European countries.
Martin Shkreli is once again provoking alarm with a plan to sharply increase the price of a decades-old drug for a serious infectious disease. This time the drug treats Chagas disease, a parasitic infection that can cause potentially lethal heart problems.
KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), today announced that it has signed an agreement to acquire a benznidazole program for the treatment of Chagas Disease from Savant Neglected Diseases, LLC, a privately-held specialty pharmaceutical company. Under the terms of the agreement, KaloBios will pay an upfront payment of $2 million, plus regulatory milestones and a royalty based on product sales. The transaction is expected to close in the coming weeks.
progression A 40 to 80 day treatment with the antiparasitic medication benznidazole significantly reduced parasite activity in the blood, but not progression, of serious heart problems over a 5-year period among patients with established Chagas disease (CD) cardiomyopathy, results of the BENEFIT trial show.