Dx firm to be acquired by Roche in up-to-$425M deal
GeneWEAVE BioSciences, a diagnostics firm, will be purchased by Roche in a deal worth up to $425 million. The acquisition will boost Roche's efforts against drug-resistant bacteria, giving it access to GeneWEAVE's Smarticles platform, which can quickly identify multidrug-resistant bacteria from clinical samples. Under the terms of the agreement, GeneWEAVE is entitled to receive an upfront payment of $190 million and up to $235 million in potential milestone payments. Reuters
(8/13), PharmaTimes (U.K.)
(8/13)
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Joint fusion system from Zyga cleared by FDA
The Simmetry system, a sacroiliac joint fusion device developed by Zyga Technology for single or double incisions, has obtained 510(k) clearance from the FDA. The Minnetonka, Minn.-based firm manufactures surgical devices designed to address lumbar spine disorders. MassDevice.com (Boston)
(8/13)
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AdvaMed: Unique device identifiers would boost postmarket medtech surveillance
While critics and new research raise safety concerns over the proposed expedited pathway for breakthrough treatments called for in the 21st Century Cures bill, AdvaMed contends that the use of unique device identifiers could make the postmarket surveillance of medical devices stronger. The group said although rigorous postmarket review is necessary, it must be balanced against patients' needs because "requirements that are too burdensome will discourage development and dissemination of new treatments and cures." The Examiner (Washington, D.C.)
(8/13)
FDA clears blood pregnancy test from NOWDiagnostics
The ADEXUSDx, a blood test designed by NOWDiagnostics to detect pregnancies in 10 minutes, has received 510(k) clearance from the FDA. The Springdale, Ark., firm said the product delivers faster results than urine-based tests. It is now available in Europe and the U.S. FDAnews
(8/14)
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Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. 29-30 | Washington, D.C.
You'll gain knowledge about Japan's revised Pharmaceutical and Medical Devices Law and its impact from key Japanese officials. Case studies and examples from the first year of implementation will also be discussed. Regulatory affairs and R&D officers at the operational and management levels who support product registration in Japan, as well as quality affairs and operation officers who are involved in QMS audits at a source plant, will benefit from this workshop. Learn more.
Recalls From A to Z: Regulations, Decisions, Procedures & Best Practices
Oct. 27-28 | Washington, D.C.
FDA staff and industry leaders will help you establish a clear understanding of how the regulatory affairs function is pivotal to every recall and every team decision. You'll partake in detailed discussions and strategies for communicating with the FDA, and learn the points to consider when writing public recall notifications. Learn more.
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