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Vyome Biosciences Announces Top-Line Results from Phase 1 Study of VB-1953
Wednesday, February 08, 2017Vyome Biosciences a clinicalstage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes today announced topline data from its phase clinical trial evaluating VB a topically administered g...
FDA Approves Amgen's Parsabiv™ (Etelcalcetide) for Secondary Hyperparathyroidism
Wednesday, February 08, 2017Amgen today announced that the US Food and Drug Administration FDA has approved Parsabiv etelcalcetide for the treatment of secondary hyperparathyroidism HPT in adult patients with chronic kidney disease CKD on hemodialysis Parsabiv is the first ther...
AMRI Announces Strategic Alliance to Advance Mass Spectrometry Capabilities for Drug Discovery
Wednesday, February 08, 2017AMRI a global contract research and manufacturing organization working to improve patient outcomes and quality of life has entered an alliance with Bruker Daltonics and HighRes Biosolutions to develop new applications for using high throughput mass s...
Quotient Clinical expands into USA through acquisition of SeaView Research, the specialist clinical pharmacology business
Tuesday, February 07, 2017Quotient Clinical Quotient the early phase drug development services provider today announces that it has acquired SeaView Research SeaView expanding its operations into the USA The acquisition combines Quotient and SeaViews complementary customer po...
Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light-activated AU-011 for the Treatment of Ocular Melanoma
Tuesday, February 07, 2017Aura Biosciences a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates announced today that the US Food and Drug Administration FDA has cleared the investigation...
Strata Oncology Announces Collaboration with Epizyme to Support Tazemetostat Clinical Development
Tuesday, February 07, 2017Strata Oncology a precision oncology company today announced an agreement with Epizyme to support patient identification and enrollment for Epizymes ongoing Phase clinical trial of tazemetostat in patients with relapsed or refractory nonHodgkins lym...
Portola Pharmaceuticals Signs $150 Million Royalty Agreement with HealthCare Royalty Partners for Development and Commercialization of Andexanet Alfa
Monday, February 06, 2017Portola Pharmaceuticals Inc PTLA today announced that it has signed a million royalty agreement with HealthCare Royalty Partners HCR Under the terms of the agreement Portola received million at closing and may receive an additional million upon US...
FDA Accepts Two sBLAs for Merck’s KEYTRUDA® (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Trea
Monday, February 06, 2017Merck NYSEMRK known as MSD outside the United States and Canada today announced that the US Food and Drug Administration FDA has accepted for review two supplemental Biologics License Applications sBLAs for KEYTRUDA pembrolizumab the companys antiPD...
Teva Confirms Generic Victoza® Patent Challenge in the United States
Friday, February 03, 2017Teva Pharmaceutical Industries Ltd announced that it has filed an abbreviated new drug application ANDA with the US Food and Drug Administration FDA seeking approval to market the generic version of Novo Nordisks Victoza liraglutide injection in the...
Lysogene Receives Orphan Drug Designation from FDA for LYS-GM101
Friday, February 03, 2017Lysogene a leading clinicalstage biotechnology company specializing in gene therapy for rare central nervous system diseases today announced that the US Food and Drug Administration FDA has granted orphan drug designation to LYSGM the companys gene t...
