Month: December 2018

FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid

Shots: The approval is based on the STML-401-0114 (NCT 02113982) study assessing immunophenotypic diagnostic CD123, CD4 & CD56 patients in treatment-naïve and previously-treated patients IV STML-401-0114 results: Elzonris(12 mcg/kg/day): ORR 90% (26/29); CR/CRc 72% (21/29); 45% of patients went for SCT post Elzonris treatment Elzonris is a CD123-targeted therapy indicate to treat adult and pediatric patients with […]Read More

Sanofi and Merck Receives FDA Approval for Vaxelis in Pediatric

Shots: Vaxelis a hexavalent combination vaccine is approved for the prevention of Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B and Haemophilus influenzae type B in children from 6 wks. to 4 yrsF Vaxelis vaccination require to complete in 3 dose series (0.5 ml, IM) in age group 2/4/6 mos. Vaxelis is a combination of Diphtheria and […]Read More

Horizon Pharma’s Ravitchi (Glycerol Phenylbutyrate) Receives FDA Approval for Expansion

Shots: The expansion approval of age range for ravicti is based on the study assessing safety, efficacy and PK in UCD infants patients aged ≤ 2mos. The study demonstrated safety and efficacy in children younger than two months, with stable ammonia levels relative to pre-study enrollment Ravitchi (glycerol phenylbutyrate) is an oral nitrogen binding agent liquid, indicated for chronic […]Read More

JHL Biotech Reports Randomization of Patients in P-III Study of

Shots:   The study involves assessing of JHL1101 + CHOP (J-CHOP) vs rituximab + CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma  Post P-III Study of JHL1101 and combination therapy, JHL Biotech plans to conduct PK study in RA patients in EU JHL1101 (biosimilar to Rituximab) is a mAb targeting CD20 cells, for […]Read More

Merck and Pfizer Reports Results of Avelumab in P-III JAVELIN

Shots: The P-III JAVELIN Ovarian 100 study involves assessing of avelumab + and/or following Pt-based carboplatin/paclitaxel CT in 998 patients with LA or metastatic (Stage III or Stage IV) epithelial ovarian cancer, fallopian tube cancer (FTC), or primary peritoneal cancer The study resulted in unmet 1EPs as PFS and has shown no new safety signals with consistent safety profile […]Read More

AbbVie Licenses Lupin’s MALT1 Inhibitor Program, for $977M

Shots: Lupin to receive $30M upfront, up to $947M milestones and royalties on sales. AbbVie to get exclusive worldwide (Ex. India) rights to develop and commercialize Lupin’s MALT1 inhibitors The focus of the agreement is to utilize Lupin’s Drug Discovery platform to develop treatments for multiple hematological cancers MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) Inhibitor Program involves protein […]Read More

Alexion’s Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval in Patients with Paroxysmal

Shots: The approval is based on P-III study results assessing of Ultomiris (IV qw, q8w) vs Soliris in 441 patients who were not treated with inhibitors or Soliris with patiparoxysmal nocturnal hemoglobinuria (PNH) The study demonstrated a non-inferiority data showing biosimilarity of Ultomiris to Soliris q2w with safe and well tolerated profile Ultomiris (ravulizumab-cwvz) is a […]Read More