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India upgrading to the new Medical Device Regulations

Jun 20, 2018
Critical medical devices such as pacemakers, CT scanners and X-ray machines will soon have an assurance of quality, with the government set to regulate their manufacture, import and…
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Agenda Released for USA Biosimilars Conference this November

Jun 20, 2018
SMi Group Reports: The official agenda for the 5th annual Biosimilars USA conference, which is taking place on the 14th and 15th November 2018 in New Jersey, USA, has been released.…
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Latest Updates on SMi’s 13th Annual Industry Leading Cold Chain Distribution Conference

Jun 20, 2018
For the 13th successful year running, SMi are expanding the scope of the conference to cover all aspects related to cold chain distribution, including how best to maintain GDP…
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Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar

Jun 18, 2018
Celltrion has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab).…
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Seattle Genetics Announces First Patient Dosed in Phase 2 Trial of Tisotumab Vedotin for Women with…

Jun 15, 2018
Seattle Genetics announced dosing of the first patient in the phase 2 innovaTV 204 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy…
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Pharmacolog AB and HelioMetrics Partner to Provide Critcal Drug Diversion Solutions

Jun 15, 2018
Pharmacolog AB and HelioMetrics announced a new partnership that will deliver solutions designed to stop drug diversion and provide safe administration of IV medications for hospitals…
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Acerus Announces Approval of NATESTO in South Korea

Jun 15, 2018
Acerus Pharmaceuticals Corporation announced that Hyundai Pharm Co., Ltd. (Hyundai), Acerus’ licensee, reported that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved…
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WuXi STA First CDMO to Support the Approval of an Innovative Drug in China Through the…

Jun 15, 2018
STA Pharmaceutical, a subsidiary of WuXi AppTec, congratulates its partner Ascletis for receiving approval from National Drug Administration of China (CNDA, former CFDA) of its Category…
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New Speakers from Roche and Imperial College London Announced for SMi’s ADMET Event

Jun 15, 2018
SMi Group Reports: With less than 4 weeks left until the 13th annual ADMET Conference commences in London, SMi announces two new speakers joining the event. There is less than 4…
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Prana to Commence Phase 1 Clinical Trial of PBT434 for Treatment of Parkinsonian Diseases

Jun 14, 2018
Prana Biotechnology received ethics committee approval and has commenced recruitment for its Phase I Clinical trial evaluating the safety, tolerability and pharmacokinetics of the…
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