• 20.11.2019 – 08:01

  Merck KGaA

  Merck Announces Orphan Drug Designation for Investigational Therapy Tepotinib in Patients with NSCLC Harboring MET Gene Alterations

  Darmstadt, Germany (ots/PRNewswire) - - Japanese Ministry of Health, Labour and Welfare grants orphan drug designation for diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists - MET exon 14 (METex14) skipping alterations and MET amplifications are present in ...

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• 25.09.2019 – 17:23

  OrbusNeich

  OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent

  Hong Kong (ots/PRNewswire) - OrbusNeich Medical K.K. of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent. The COMBO Plus Coronary Stent is the first drug-eluting stent [DES] to combine the proprietary endothelial progenitor cell [EPC] capture technology with an ...

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• 23.09.2019 – 08:01

  Merck KGaA

  New Data at ESMO 2019 for Merck Highlight Focused Clinical Development and Commitment to Patient Care

  Darmstadt, Germany (ots/PRNewswire) - Not intended for distribution in the USA, Canada or the UK Key ESMO Abstracts # BAVENCIO® (avelumab): 1451; 3152; 4174; 4256; 4823; 5113, ERBITUX® (cetuximab): 1212, 2589, 4455, Tepotinib (MET kinase inhibitor): 3930; 5373; 5455, M6620 (ATR inhibitor): 1547, Combinations: ...

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• 11.09.2019 – 08:30

  Merck KGaA

  Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations

  Darmstadt, Germany (ots/PRNewswire) - - Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan - MET exon 14 skipping alterations and MET amplifications are present in 3-5% of non-small cell lung cancer patients and correlate with poor prognosis - The ...

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• 09.09.2019 – 14:00

  Merck KGaA

  Updated Results for Investigational Therapy Tepotinib Presented at WCLC 2019

  Darmstadt, Germany (ots/PRNewswire) - - Results include progression-free survival and overall survival data from Phase Ib/II INSIGHT study - Phase II INSIGHT 2 study now open for enrollment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation and select MET dysregulations The ...

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• 02.08.2019 – 08:00

  Sysmex Inostics GmbH

  Sysmex obtains Japanese manufacturing and marketing approval for the first blood-based RAS mutation testing for colorectal cancer

  Kobe, Japan (ots) - Sysmex Corporation has obtained Japanese manufacturing and marketing approval for the OncoBEAM(TM) RAS CRC Kit, used for blood-based circulating tumor DNA (ctDNA) molecular testing of mutations in the RAS gene for advanced colorectal cancer patients. With clinically-validated high sensitivity and ...

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• 04.03.2019 – 14:01

  Novo Nordisk A/S

  Ozempic® Superior in Lowering Blood Sugar and Weight Vs Placebo, Both in Combination with SGLT-2 Inhibitors

  Bagsværd, Denmark (ots/PRNewswire) - Novo Nordisk today announced publication of results from the SUSTAIN 9 Phase 3b trial in The Lancet Diabetes & Endocrinology. The objective of this 30 week trial was to assess the efficacy and safety of Ozempic® (semaglutide) 1.0 mg when added to SGLT-2 inhibitor (SGLT-2i) ...

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• 26.08.2018 – 14:00

  Novo Nordisk A/S

  Ozempic® Consistently Reduced the Risk of Major Cardiovascular Events Across Type 2 Diabetes Populations at High CV Risk Regardless of Prior CV Events at Baseline

  Munich (ots/PRNewswire) - Ozempic® (semaglutide) consistently reduced the risk of the composite outcome of time to first occurrence of non-fatal heart attack, non-fatal stroke or cardiovascular death (collectively termed major adverse cardiovascular events, MACE) in people with type 2 diabetes at high ...

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