Clinical Intelligence

Shire, Kamada announce FDA Emphysema treatment GLASSIA

Friday, June 17, 2016

Shire and Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training.

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FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine

Friday, June 17, 2016

PaxVax has received marketing approval from the FDA for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world.

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Seattle Children’s leukemia trial shows 93% complete remission rate

Friday, June 10, 2016

Seattle Children’s has announced that 39 of 42 patients treated in a phase I clinical trial using genetically reprogrammed T cells to treat relapsed or refractory acute lymphoblastic leukemia (ALL) have achieved complete remission, showing no detectable leukemia cells in the most sensitive tests. Patients treated in the trial, known as Pediatric Leukemia Adoptive Therapy-02 (PLAT-02), had less than a 20% chance of survival upon enrollment using current treatments. Seattle Children’s will launch phase II of the trial this month, with the aim to enroll 70 patients in the next year.

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