USFDA

Oncternal Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapies for rare and common malignancies, announced that TK216 has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the treatment of Ewing sarcoma.

Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.

Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).

The U.S. Food and Drug Administration approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors. ExAblate Neuro is manufactured by InSightec in Dallas, Texas.

Shire plc announces that the U.S. Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Shire expects to launch Xiidra in the United States in the third quarter of 2016.

Medtronic plc announced U.S. Food and Drug Administration (FDA) clearance of NuVent(TM), an EM sinus dilation system, for patients with scarred, granulated, or previously surgically-altered tissue - an expansion of indications. Patients coming in for revision sinus surgery (RSS) have these tissue characteristics. NuVent is the first and only balloon sinus dilation system with built-in electromagnetic (EM) surgical navigation technology that may help surgeons confirm anatomy and optimize placement2 during balloon sinus surgery. RSS may be needed when sinus surgery does not alleviate suffering, and can pose unique challenges due to potential scar tissue and altered anatomy from previous surgeries. Image-guided surgery may have advantages for some types of revision cases.3

BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, announced that it has entered into a ten-year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor (CAR) and T cell receptor (TCR) products for various cancers.