Industry News

• NuVasive launches first-of-its-kind Brigade® lateral implant and instrumentation for ALIF  NuVasive announced the U.S. commercial launch of Brigade® Lateral, the industry's first interbody implant and instrumentation optimized for lateral anterior lumbar interbody fusion spine surgery.
  November 15, 2018  
• NewLink Genetics announces Merck has begun rolling submission of licensure application  NewLink Genetics reported that Merck has begun the submission of a rolling BLA to the FDA for V920 (rVSV∆G-ZEBOV-GP, live attenuated). This rolling submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920, which was announced by Merck in July 2016.
  November 15, 2018  
• FDA grants Breakthrough Therapy Designation to ADCETRIS® (brentuximab vedotin)  Seattle Genetics announced the FDA has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas.
  November 15, 2018  
• Arena Pharma and United Therapeutics announce global license agreement for ralinepag  Arena Pharmaceuticals and United Therapeutics announced the companies have entered into a global license agreement for Arena's Phase 3 investigational drug candidate, ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of PAH.
  November 15, 2018  
• Blueprint Medicines announces updated NAVIGATOR trial results  Blueprint Medicines announced updated data for the registration-enabling NAVIGATOR clinical trial of avapritinib. The data showed that avapritinib was highly active across all lines of therapy for patients with PDGFRα D842V-driven GIST and in second-, third- and fourth-line for other GIST patients.
  November 15, 2018  
• AVEO Oncology announces $2 million milestone payment from EUSA Pharma  AVEO Oncology announced the triggering of a $2 million milestone payment to AVEO from EUSA Pharma. The milestone payment relates to the commercial launch and reimbursement in Germany of FOTIVDA® (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma.
  November 15, 2018  
• Exelixis' partner Ipsen receives EC approval for CABOMETYX® (cabozantinib) tablets  Exelixis announced that its partner Ipsen received approval from the EC for CABOMETYX® (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma in adults who have previously been treated with sorafenib.
  November 15, 2018  
• Boehringer Ingelheim and Epizyme announce worldwide collaboration  Boehringer Ingelheim and Epizyme announced a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer.
  November 15, 2018  
• NIH scientists combine technologies to view the retina in unprecedented detail  By combining two imaging modalities investigators at the National Eye Institute can see live neurons, epithelial cells, and blood vessels deep in the eye’s light-sensing retina. The paper was published online in Communications Biology.
  November 14, 2018  
• Merck’s KEYTRUDA® (pembrolizumab) significantly improved OS versus chemotherapy   Merck announced the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma met a primary endpoint of overall survival in patients whose tumors expressed PD-L1.
  November 14, 2018  

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