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10/12/2018

Former FDA Commissioner Margaret Hamburg will assume the Alnylam board seat of John Clarke when he retires in January. Hamburg is foreign secretary of the National Academy of Medicine, president-elect of the American Association for the Advancement of Science, is on the Bill and Melinda Gates Foundation advisory committee and holds other board seats.

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Endpoints News
10/12/2018

Chemist Vivienne Cox was appointed chair of the Rosalind Franklin Institute, a new national life sciences hub in the UK, where her goal will be to break down silos and bring together university research and industry. Cox is nonexecutive director of GlaxoSmithKline and Stena, a senior director at Pearson and board chair of Vallourec.

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GlaxoSmithKline, Pearson
10/12/2018

The FDA has approved Palynziq, or pegvaliase, as a treatment for adults with phenylketonuria. "Pegvaliase is very effective in metabolizing phenylalanine, making it possible for most patients who respond to the medication to consume a normal amount of food protein," study author Barbara Burton said.

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Rare Disease Report
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FDA, Pegvaliase, Palynziq
10/12/2018

Spero Therapeutics' SPR206, being developed to treat patients with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia or complicated urinary tract infections, was given qualified infectious disease product designation by the FDA. The company intends to launch a safety, tolerability and pharmacokinetic early-stage study of the candidate next year.

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10/12/2018

The Dual Differential Correction Philosophy & Technique, developed by K2M for its Mesa Platform Technology to treat sagittal imbalances in the spine, has received FDA clearance. The technique corrects a patient's imbalances using rod rigidity and degree of bend, as well as patient-specific rods and rails.

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K2M, FDA
10/12/2018

Health Canada has granted Medtronic Canada license to market the MiniMed 670G insulin pump system for patients with type 1 diabetes ages 7 and older. The system, which is expected to be launched in Canada this fall, enables automatic basal insulin delivery adjustment based on real-time needs of users.

10/12/2018

More than 35,000 pounds of refrigerated pasta entrees that contain meat and chicken are being recalled by Valley Fine Foods after routine internal testing found they could be contaminated with spoilage organisms. The recalled products were distributed to California, North Carolina, Connecticut, Massachusetts, Maryland and Michigan.

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Food Safety News
10/12/2018

Rigel Pharmaceuticals' marketing application for Tavalisse, or fostamatinib disodium hexahydrate, indicated for the treatment of chronic immune thrombocytopenia, has been accepted by the European Medicines Agency for review. The EMA's advisory group, the Committee for Medicinal Products for Human Use, is expected to announce its opinion in the last quarter of 2019.

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10/12/2018

Iovance Biotherapeutics intends to enroll a cohort of 80 to 100 patients to its ongoing midstage study of LN-144-01 for melanoma early next year and submit a marketing application to the FDA in the second half of 2020. Initial results from the study demonstrated a 37% objective response rate in patients with advanced melanoma who received a PD-1 inhibitor and a BRAF inhibitor if the disease is BRAF mutation-positive.

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Iovance Biotherapeutics, FDA
10/12/2018

A merger deal between scientific research company Spherix and CBM BioPharma will result in CBM receiving 15 million shares of common stock from Spherix. The deal will also grant Spherix access to two experimental drugs, one for acute myeloid leukemia and acute lymphoblastic leukemia and another for pancreatic cancer.

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