Unimed and Besins Sue Sandoz Over Challenge to AndroGel Patents December 7, 2015 Two companies are suing generic drugmaker Sandoz for challenging their patents to the testosterone gel product AndroGel. Read More
MHRA Guidance Seeks to Clarify Baseline Submissions December 7, 2015 Baseline submissions usually are required when converting the format for regulatory submissions or correcting technical issues. Read More
EMA Grants Orphan Drug Designation to Advaxis Osteosarcoma Candidate December 7, 2015 ADXS-HER2 targets cancers expressing human epidermal growth factor receptor 2. Read More
PhaseBio Awarded FDA Orphan Drug Designation for Cardiomyopathy Treatment December 7, 2015 The Vasomera injection is for the treatment of cardiomyopathy associated with dystrophinopathies. Read More
Cellceutix’s Kevetrin Wins Rare Pediatric Disease Designation December 7, 2015 The treatment is designed for the treatment of retinoblastoma. Read More
FDA Awards Eiger’s Ubenimex Orphan Drug Designation for PAH December 4, 2015 An oral, small molecule, ubenimex is a dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase. Read More
BMS’ Opdivo Hit With FDA Roadblock for Expanded Indication to Treat Metastatic Melanoma December 4, 2015 The FDA is seeking more data before approval. Read More
EC Green Lights Exelixis’ Cotellic for Metastatic Melanoma December 3, 2015 The therapy is approved for use in combination with vemurafenib. Read More
FDA Fast Tracks Cellceutix’s Oral Mucositis Candidate December 3, 2015 The candidate is currently in Phase 2 trials in patients undergoing chemoradiation for the treatment of head and neck cancer. Read More
FDA Awards Lysogene Orphan Drug, Rare Pediatric Disease Designations December 3, 2015 LYS-SAF-302 is a gene therapy candidate for treating patients with Sanfilippo Type A. Read More
Pfizer Wins Expanded Approval for Xalkori in Europe December 3, 2015 The drug now is approved for the treatment of adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. Read More
GSK Receives EC Expanded Indication for PAH Drug December 2, 2015 The drug’s use is approved in combination treatment for PAH patients. Read More