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FDA clears Biobeat wearable watch and patch for BP measurement

FDA clears Biobeat wearable watch and patch for BP measurement

Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for its wearable watch and patch for monitoring blood pressure (BP), oxygenation, and heart rate in clinics, hospitals, long term care and at home. The user will have to use one or the other device, while the watch […]

ProteKt secures funding for PKR kinase inhibitor-based therapies

Israeli biotech company ProteKt Therapeutics, which is focused on developing new PKR kinase inhibitor-based therapies for Alzheimer’s Disease and other neurodegenerative diseases, has secured $3.6 million in post-incubation financing. The financing was led jointly by Canadian capital development fund Fonds de solidarité FTQ and South Korean pharma company Bukwang Pharmaceutical. Existing investors – FutuRx, OrbiMed, […]

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Pepticom secures investment for AI-driven peptide drug discovery

Israel-based Pepticom, which is engaged in using artificial intelligence (AI) for peptide drug discovery, has raised $5 million in a Series A funding round from the Chartered Group. Pepticom is a spin-out of Yissum, the technology transfer company of The Hebrew University of Jerusalem. The company’s artificial intelligence technology is said to optimize and significantly speed […]

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Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne

AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for AMZEEQ (minocycline) topical foam, 4% for the treatment of moderate to severe acne. Previously known as FMX101, AMZEEQ has been indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne […]

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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 […]

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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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