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Technology & Devices

FDA Grants Breakthrough Device Designation to Artificial Intelligence Software for CTEPH Pattern Recognition from Bayer and MSD

Berlin, December 3, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). A …

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HitGen Enters into DNA-Encoded Library Based Drug Discovery Research Collaboration with Genentech

CHENGDU, China–(BUSINESS WIRE)–HitGen Ltd today announced that it has entered into a drug discovery research collaboration with Genentech, a member of the Roche Group, to identify potential small molecule leads against targets of interest to Genentech. In this collaboration, HitGen will apply its technology platform, based on DNA-encoded library design, …

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FDA Authorizes First Test to Aid in Detecting Cytomegalovirus in Newborns

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, …

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Daiichi Sankyo and Roche to Collaborate on New HER2 Low Companion Diagnostic Test

TOKYO and MUNICH and BASKING RIDGE, N.J., Nov. 27, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into an agreement with Roche to collaborate on the development of a new HER2 low companion diagnostic test. Under the terms of the agreement, Roche …

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BeiGene Acquires Rights to Zymeworks’ HER2-Targeted Candidates and Enters License Agreement for Zymeworks’ Azymetric and EFECT Platforms

VANCOUVER, Canada & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the two companies …

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Rocket Pharmaceuticals and REGENXBIO Announce New License Agreement for the Treatment of Danon Disease Using NAV AAV9 Vector

NEW YORK & ROCKVILLE, Md.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (Nasdaq:RCKT), a leading U.S.-based multi-platform gene therapy company, and REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced an exclusive, worldwide license agreement for …

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HitGen and Biogen Enter a DNA-Encoded Library-Based Drug Discovery Research Collaboration

CHENGDU, China–(BUSINESS WIRE)–HitGen Ltd announced that the company has entered into a drug discovery research collaboration with Biogen to identify novel small molecule leads for targets of interest. In this collaboration, HitGen will apply its technology platform, based on DNA-encoded library design, synthesis and interrogation, to discover novel leads which …

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Ligand Announces OmniAb Partnership with iMetabolic Biopharma Corporation

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)announces it has entered into a worldwide OmniAb partnership with iMetabolic Biopharma Corporation (iMBP), an early stage biopharma company located in Tempe, AZ. Under the terms of the partnership, iMBP gains access to the full OmniAb platform including OmniRat®, OmniMouse®, OmniFlic®and OmniChicken™ in their drug …

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Boston Scientific Offers to Buy UK Medical Device Firm BTG for $4.2 Billion

MARLBOROUGH, Mass., Nov. 20, 2018 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc. (LSE: BTG), a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well …

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Dragonfly and Celgene Expand Collaboration in Immunotherapies for Patients with Solid and Hematological Cancers

WALTHAM, Mass., Nov. 14, 2018 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly” or the “Company”), today announced it entered into a new agreement with Celgene Corporation and its affiliates (“Celgene”) to discover, develop and commercialize innovative immunotherapies for patients with solid and hematological cancers. The new agreement builds upon Celgene’s existing …

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