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Quidel Receives Simultaneous FDA Clearance And CLIA Waiver For Its Sofia(R) Strep A Fluorescent Immunoassay (FIA) Via The FDA’s New Dual Submission ProgramSAN DIEGO, CA–(Marketwired – Dec 17, 2014) – Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today…
SAN DIEGO, Dec. 18, 2014 /PRNewswire/ — HUYA Bioscience International, a leader in accelerating the global development of China’s pharmaceutical innovations, today announced a strategic collaboration agreement with China Wuqing Development Area, a state-level economic and technological…
SAN DIEGO, Dec. 17, 2014 /PRNewswire-iReach/ –eLux Medical, Inc., developer of NanoLipo, a novel nanomedicine approach to liposuction, is pleased to announce that Peter C. Farrell, PhD, DSc, AM, has joined its Business Advisory Board. Dr. Farrellis founder and chairman of the…
ViaCyte, Inc. (Formerly Known as Novocell, Inc.) Release: Study Further Validates Cell Therapy Approach To Reverse Type 1 Diabetes
SAN DIEGO, Dec. 18, 2014 /PRNewswire/ — ViaCyte, Inc. announced today a preclinical study published online in Cell Stem Cell that describes a novel approach to replace the insulin-producing cells that are lost in type 1 diabetes. The approach utilizes pancreatic precursor cells derived from human embryonic…
Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia(R) Strep A+ Fluorescent Immunoassay (FIA) via the FDA’s New Dual Submission Program
SAN DIEGO, CA–(Marketwired – Dec 17, 2014) – Quidel Corporation ( NASDAQ : QDEL ), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.
Halozyme Therapeutics Inc., a San Diego-based biopharmaceutical company, will receive $15 million as an initial payment from Pennsylvania-based Janssen Biotech Inc. as part of a collaboration and license agreement to develop and commercialize products combining Halozyme’s technology with Janssen’s compounds.
Royal Philips to pay $1 billion cash for San Diego medical instrument company.
Competing breast and ovarian cancer tests using BRCA sequences can remain on market.
Halozyme advances reach of drug delivery technology.
Halozyme Therapeutics Enters A Global Collaboration With Janssen To Develop And Commercialize Subcutaneous Products Using ENHANZE™ Technology
SAN DIEGO, Dec. 17, 2014 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that it has entered into a worldwide Collaboration and License Agreement with Janssen Biotech, Inc. (Janssen) for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme’s ENHANZE™ technology. ENHANZE is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily modifies hyaluronan, a component of the extracellular matrix, to aid in the dispersion and absorption of other injected therapeutic drugs.
“We are pleased that Janssen, a global leader in the development of novel therapeutics, has selected our ENHANZE technology to further augment their development pipeline,” said Dr. Helen Torley, President and Chief Executive Officer. “This new global licensing agreement further validates our ENHANZE platform technology, which we believe may benefit a growing number of patients worldwide by making therapies more convenient.”
Under the terms of the agreement, Halozyme has granted to Janssen a worldwide license to develop and commercialize products for up to five targets combining rHuPH20 with Janssen’s proprietary compounds. Halozyme will receive an initial payment of $15 million, and is eligible to receive additional payments upon Janssen’s achievement of specified development, regulatory and sales-based milestones, totaling up to $566 million. Halozyme is also entitled to royalty payments based on net sales of products using the ENHANZE technology. Under the collaboration, Janssen will also obtain access to Halozyme’s expertise in developing and applying rHuPH20 to Janssen targets and will obtain a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Janssen target compounds resulting from the collaboration.
ENHANZE™ is Halozyme’s proprietary drug delivery platform based on the Company’s patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the development and commercialization of product candidates under the Halozyme-Janssen collaboration, the potential benefits and attributes of such product candidates, the possible receipt by Halozyme of future payments including milestones and royalties) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events, competitive conditions and the continuation of the Halozyme-Janssen collaboration. These and other factors that may result in differences are discussed in greater detail in Halozyme’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014.
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SOURCE Halozyme Therapeutics, Inc.