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V-Wave Interatrial Shunt System gets FDA breakthrough device status for HF

V-Wave Interatrial Shunt System gets FDA breakthrough device status for HF

Israeli medical device company V-Wave has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its V-Wave Interatrial Shunt System for heart failure (HF). The minimally invasive, implanted interatrial shunt is being investigated by the Israeli medical device company in a global, randomized, controlled, double-blinded investigational device exemption (IDE) trial […]

89bio begins phase 1b/2a NASH clinical trial of BIO89-100

BIO89-100 NASH clinical trial : US-based biopharma company 89Bio has initiated a proof of concept phase 1b/2a clinical trial for BIO89-100, its NASH drug in development, by screening the first patients. The proof of concept trial will evaluate the glycoPEGylated analog of fibroblast growth factor 21 (FGF21) in patients with nonalcoholic steatohepatitis (NASH) or patients […]

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Foamix files NDA seeking FMX103 FDA approval for rosacea

Israeli pharma company Foamix Pharmaceuticals has filed a new drug application (NDA) for FMX103 to the US Food and Drug Administration (FDA) seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over. Considered to be a common skin condition, rosacea results in redness and visible blood vessels in the face. […]

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OSSIO launches OSSIOfiber Bone Pin for hammertoe correction in US

Israeli orthopedic medical device company OSSIO has launched the OSSIOfiber Bone Pin Family for maintenance of alignment and fixation of bone fractures, arthrodesis, bone grafts, and osteotomies. The first commercial cases of the the OSSIOfiber Bone Pin Family was in the hammertoe repairs carried out at Polaris Surgery Center in Westerville, Ohio. Dr Gregory Berlet, […]

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Stryker acquires Israeli medical device company OrthoSpace

Stryker acquisition of OrthoSpace : US medical technologies firm Stryker has acquired an Israeli medical device company OrthoSpace in an all-cash deal worth up to $220 million. As per the deal terms, Stryker made an upfront payment of $110 million and has committed to future milestone payments up to $110 million. Established in 2009 in […]

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BMS, Compugen to trial COM701 Opdivo combo in advanced solid tumors

US biopharma company Bristol-Myers Squibb (BMS) has entered into a clinical collaboration with Compugen to evaluate the combination of its cancer drug Opdivo (nivolumab) with the Israeli genomics-based drug and diagnostic discovery company’s COM701 in advanced solid tumors. COM701 is being investigated by Compugen as an anti-PVRIG antibody while the cancer drug Opdivo is a […]

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Compugen kickstarts phase 1 trial of cancer immunotherapy COM701

Israeli pharma company Compugen has dosed the first patient in the phase 1 clinical trial which is evaluating the company’s cancer immunotherapy antibody COM701 in patients with advanced solid tumors. COM701 has been designed to target the PVRIG gene, which according to the Israeli pharma company is a novel immune checkpoint target it had identified […]

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