Industry News

• Atara Biotherapeutics Presents Positive Efficacy and Safety Results   Atara Biotherapeutics reported results indicating that tab-cel® (tabelecleucel) was generally well tolerated with responses for patients with Epstein-Barr virus-associated leiomyosarcoma. EBV+ LMS is a rare soft tissue sarcoma that occurs in transplant and immunosuppressed patients.
  December 15, 2018  
• Teva - Celltrion and Teva announce FDA approval of HERZUMA® (trastuzumab-pkrb)  Celltrion and Teva Pharmaceutical announced that the FDA has approved HERZUMA® (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to HERCEPTIN® (trastuzumab) for Adjuvant Breast Cancer of HER2 and Metastatic Breast Cancer.
  December 14, 2018  
• Supernus announces FDA approval of sNDA to expand Oxtellar XR® label  Supernus announced the FDA has approved the Company’s sNDA for Oxtellar XR®. The application requested FDA approval to expand the indication for Oxtellar XR® beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.
  December 14, 2018  
• Research suggests path to vaccine or drug for late-onset Alzheimer’s  Researchers have succeeded in neutralizing what they believe is a primary factor in late-onset Alzheimer’s disease, opening the door to development of a drug that could be administered before age 40, and taken for life, to potentially prevent the disease in 50 to 80 percent of at-risk adults.
  December 14, 2018  
• FDA approves Nplate® (Romiplostim) for use in pediatric patients with ITP  Amgen announced the FDA has approved the sBLA for Nplate® (romiplostim) for treatment of pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
  December 14, 2018  
• Astellas acquires Potenza Therapeutics for $240.1 million  Astellas Pharma announced it exercised, and closed on its exclusive option to acquire Potenza Therapeutics on Dec. 13, 2018. This acquisition marks the successful outcome of a collaboration agreement entered into in 2015 to build a portfolio of novel immuno-oncology therapies.
  December 14, 2018  
• NIH scientists find that breast cancer protection from pregnancy starts decades later  NIH scientists, along with members of the international Premenopausal Breast Cancer Collaborative Group, found breast cancer risk increases in the years after a birth, with the highest risk of developing the disease about five years later. The findings appeared in the Annals of Internal Medicine.
  December 14, 2018  
• iBio reports update on continuing litigation against Fraunhofer  iBio announced the Second Complaint it filed in iBio’s litigation against the Fraunhofer organization complaining that FhG had committed fraud against and was responsible for contractual breaches against iBio – was dismissed by the Delaware Chancery Court as untimely filed.
  December 14, 2018  
• Idera Pharma reports clinical safety and efficacy update from ILLUMINATE-204 trial  Idera reported data from the ongoing phase 2 expansion of the ILLUMINATE-204 trial investigating tilsotolimod, Idera’s intratumorally-delivered toll-like receptor 9 (TLR9) agonist, in combination with ipilimumab (Yervoy®). The combination regimen continues to be generally well tolerated.
  December 14, 2018  
• KalVista Pharmaceuticals reports fiscal second quarter results  KalVista reported the net loss was $3.3 million for 2018 second quarter versus a net loss of $5.0 million for the same 2017 period. Revenue was $5.6 million for the 2018 second quarter versus $1.1 million for the same 2017 period.
  December 14, 2018  

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