Wednesday, September 2, 2015
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.
Halozyme Therapeutics, an oncology biotech company headquartered in San Diego, has announced its chief financial officer David Ramsay will retire this summer, and named biotech veteran Laurie Stelzer as his successor. Stelzer will assume chief financial officer duties on June 15 and will work with Ramsay through a transition period.
Amgen has created a catalog of qualified tools and reagents available to academic institutions to help further research and advance basic discoveries in biology, as well as deepen relationships with academic institutions. This catalog and its associated materials are called the Amgen Biology-Enabling Resource (AmBER).
Amgen has released pooled data from two pivotal phase III, global, randomized, placebo-controlled trials evaluating AMG 416, a novel calcimimetic, for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. Both studies met the primary endpoint, demonstrating that a greater proportion of patients in the AMG 416 groups achieved a greater than 30% reduction in parathyroid hormone (PTH) during the efficacy assessment phase compared with placebo.
The Massachusetts Life Sciences Center (MLSC), an investment agency that supports life sciences innovation, research, development and commercialization, has awarded $19 million in tax incentives to 11 life sciences companies. The recipients have committed to creating 1,075 new jobs in the Commonwealth in 2015.
Ruthigen, a biopharmaceutical company based in Santa Rosa, Calif., and Pulmatrix, a Lexington, Mass.-based clinical stage biotech, have entered into a definitive merger agreement. Pulmatrix will become a wholly-owned subsidiary of Ruthigen and all of Pulmatrix’s debt and equity securities outstanding prior to the consummation of the merger will be exchanged for shares of Ruthigen common stock that will represent approximately 81% of the outstanding common stock of Ruthigen.
The GPCR Consortium, an international nonprofit collaboration that comprises academic research institutes in the U.S. and China and major pharma companies around the world, has announced Novo Nordisk and Merck as new members. The companies join Amgen, Sanofi and Ono in the GPCR Consortium. The research funded by the GPCR Consortium currently is conducted at the Bridge Institute at the University of Southern California, Shanghai Institute of Materia Medica and the iHuman Institute at ShanghaiTech University.