Pharma News

Luminex Corporation announced that it has received medical device licenses from Health Canada's Therapeutic Products Directorate, Medical Devices Bureau for the ARIES® System and ARIES® HSV 1&2 Assay. The ARIES® System and HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the U.S. market.

In an important advancement towards an effective treatment against the deadly Ebola virus disease (EVD), researchers have found that a single monoclonal antibody isolated from a human survivor completely protects monkeys from lethal infection with the virus.

A team of US researcher has found that a laser system already in place to kill brain tumours can also be used to disrupt temporarily the blood-brain barrier enabling the crucial chemotherapy drugs to pass into the brain for up to six weeks.

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Children with autism who often suffer impairments in communication can develop their speech, gestures and a sense of rhythm and melody by listening to various speech sounds, says a study.

AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s single-dose, preservative-free formulation of Makena® (hydroxyprogesterone caproate injection). Makena is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past.

Boston Scientific  has received U.S. Food and Drug Administration (FDA) approval for the ACUITY™ X4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market.

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States. Patients with aortic stenosis, who are at a low surgical mortality risk as determined by a heart team, will be enrolled in the trial.

PTC Therapeutics, Inc. announced that it received yesterday evening a Refuse to File letter from the United States Food and Drug Administration (FDA) regarding PTC's New Drug Application (NDA) for Translarna™ (ataluren), an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

A form of natural sugar that triggers liver cells to clean up excess fat may help tackle nonalcoholic fatty liver disease (NFLD) in the near future, researchers have found after conducting a key research on mice.

Researchers have discovered that copper has the properties to destroy the “superbug” methicillin-resistant Staphylococcus aureus (MRSA) - a bacteria that is resistant to many antibiotics.