Industry News

• Akcea and Ionis report positive data from phase 2 study of AKCEA-APO(a)-LRx  Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, announced positive topline results from a Phase 2 clinical study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a).
  September 24, 2018  
• NuVasive expands biologics portfolio to meet clinical and economic needs  NuVasive announced the U.S. commercial launch of three new biologics offerings to include traditional bone allograft, amniotic membrane DS and additional form factors to the current PropelTM DBM product line.
  September 24, 2018  
• Roche's investigational medicine entrectinib showed durable response of more than two year  Roche announced results for its investigational medicine entrectinib, from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA trials, which showed entrectinib shrank tumours (ORR) in 77.4% of people with locally advanced or metastatic ROS1-positive NSCLC.
  September 24, 2018  
• BioXcel Therapeutics expands immuno-oncology partnership with Nektar in pancreatic cancer  BioXcel and Nektar announced a new clinical partnership. The collaboration will evaluate the combination of BTI’s BXCL701, a small molecule immune-modulator, DPP 8/9 and FAP inhibitor; Nektar’s NKTR-214, a CD122-biased agonist; and a checkpoint inhibitor as potential therapy for pancreatic cancer.
  September 24, 2018  
• Boston Scientific receives FDA approval for EluviaTM drug-eluting vascular stent system  Boston Scientific announced the FDA has approved its Premarket Approvalapplication to market the Eluvia™ Drug-Eluting Vascular Stent System, specifically developed for treatment of peripheral artery disease.
  September 24, 2018  
• XBiotech announces completion of U.S. enrollment in phase 2 study evaluating bermekimab  XBiotech announced it had completed enrollment in the U.S. for its Phase 2, open label clinical study evaluating subcutaneous administration of bermekimab in patients with moderate to severe Hidradenitis Suppurativa. Enrollment has exceeded the planned limit.
  September 24, 2018  
• Quest Diagnostics acquires ReproSource, extending into advanced fertility diagnostics  Quest Diagnostics announced it has acquired ReproSource, a national leader in specialty fertility diagnostic services. About 10 percent of women of child-bearing age in the U.S. have difficulty getting or staying pregnant, according to the Centers for Disease Control and Prevention.
  September 24, 2018  
• Astellas receives positive CHMP opinion for XTANDI® (enzalutamide) for adult men  Astellas announced that the CHMP of the EMA has adopted a positive opinion to expand the indication for Xtandi (enzalutamide) to include adult men with high-risk non-metastatic castration-resistant prostate cancer. Enzalutamide was first approved by the EC in June 2013.
  September 24, 2018  
• REDUCE-IT™ cardiovascular outcomes study of Vascepa (icosapent ethyl) met primary endpoint  Amarin announced topline results from the Vascepa® cardiovascular outcomes trial, REDUCE-IT™, a global study of 8,179 statin-treated adults with elevated CV risk. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction.
  September 24, 2018  
• Roche announces availability of blood-based genomic profiling test, FoundationOne Liquid  Roche announced today the global availability of FoundationOne®Liquid, a liquid biopsy test. FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours.
  September 24, 2018  

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