Industry News

• Janssen receives positive CHMP opinion for SPRAVATO® (ESKETAMINE) nasal spray  Janssen announced the CHMP of the EMA has recommended approval for SPRAVATO®(esketamine)nasal spray,in combinationwith a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor, for adults living with treatment-resistant major depressive disorder.
  October 18, 2019  
• Nplate® (romiplostim) now approved for earlier use in adults with immune thrombocytopenia  Amgen announced the FDA approved Amgen's sBLA) for Nplate® (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia, a rare, serious autoimmune disease characterized by low platelet counts.
  October 18, 2019  
• Aravive announces publication of AVB-500 nonclinical study in in Cancer Research  Aravive announced publication of data from a nonclinical study of AVB-500, the company’s lead product candidate, which demonstrated reduction in tumor size and blood vessel density in animal models of clear cell renal cell carcinoma. The study was published in the journal Cancer Research.
  October 18, 2019  
• Delcath Systems announces ratio for reverse stock split  Delcath Systems announces the Company’s Board of Directors has authorized a reverse stock split of the Company’s common stock at a ratio of 1-for-100. The proposal to effect a reverse stock split was approved by shareholders on Sept. 17, 2019.
  October 18, 2019  
• Rigel receives positive trend vote from CHMP for fostamatinib disodium hexahydrate  Rigel Pharmaceuticals announced the CHMP of the EMA, has adopted a positive trend vote on the MAA for fostamatinib disodium hexahydrate (fostamatinib). The indication for positive trend vote is for treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.
  October 18, 2019  
• Merck receives EU CHMP positive opinion for investigational V920 Ebola Zaire vaccine  Merck announced the CHMP of the EMA has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live).
  October 18, 2019  
• EVENITY® (romosozumab) receives positive CHMP Opinion for treatment of severe osteoporosis  Amgen announced that following a re-examination procedure, CHMP of the EMA has adopted a positive opinion recommending Marketing Authorization for EVENITY® (romosozumab) for treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
  October 18, 2019  
• Roche announces FDA approval of Xofluza (baloxavir marboxil) for high risk influenza  Roche announced the FDA has approved a sNDA for Xofluza™ (baloxavir marboxil) for treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
  October 18, 2019  
• TransEnterix provides corporate update  TransEnterix announced it has agreed to amend the previously announced AutoLap System Sale Agreement, and has engaged J.P. Morgan Securities to evaluate strategic alternatives while simultaneously re-directing its operational focus and implementing a restructuring plan to reduce expenses.
  October 17, 2019  
• Paratek withdraws European MAA for oral and intravenous NUZYRA in skin infections  Paratek announced he company has withdrawn its submission to the EMA of the Marketing Authorization Application for NUZYRA® (omadacycline). NUZYRA is a once-daily oral and IV modernized tetracycline approved by the FDA Oct. 2, 2018 for treatment of adults with CABP and ABSSSI.
  October 17, 2019  

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