European Medicines Agency

Pharma makers pull MS drug from worldwide marketIn a rare move, pharmaceutical manufacturers voluntarily recalled their drug to treat multiple sclerosis after reports of serious brain inflammation in patients.
FDA okays new diabetes, asthma drugsFDA recently approved a new diabetes medication, as well as a drug to treat severe asthma.
Bleeding disorder drug shows positive resultsAfter positive phase 3 trial data for its treatment for the bleeding disorder von Willebrand disease, Baxalta Inc. is awaiting FDA approval for the drug.
Glaucoma drug granted orphan statusThe European Medicines Agency (EMA) has granted orphan drug designation to ISTH0036, a locked nucleic acid-modified antisense oligonucleotide under development by Munich-based Isarna Therapeutics, for the prevention of scarring after glaucoma filtration surgery (GFS).
FDA green lights combination antibioticFDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.
Orphan drugs: Patients facing access issuesAs the numbers of orphan drugs increase as well as their costs, patients are facing growing challenges accessing orphan drugs, according to a study from the Tufts Center for the Study of Drug Development (CSDD) at Tufts University.
FDA, EMA to work together on pharmacovigilanceFDA plans to work closely with the European Medicines Agency (EMA) to ensure the safety of medicines, according to a Feb. 19 announcement.