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Based on the results presented at the biannual meeting July 10th in Heidelberg, Germany, Merck Serono decided to extend the funding of the first two international research groups

The EMA will initiate review of the MAA under accelerated assessment timelines. "Given the diversity of patient populations affected by chronic hepatitis C, including the estimated 15 million

HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. Around 60 patients undergoing inguinal hernia repair will be included

As part of the deal, PharmaMar will receive an upfront payment, royalties and additional remunerations for regulatory milestones achieved by Aplidin. The deal will see PharmaMar retain exclusive

Currently, Olysio is approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a

The company intends to start the trial upon investigational review board approvals and expects the first subject to be dosed within two months. LPA is a bioactive lipid

The company noted that validation of the applications confirms that the submissions are complete and starts the EMA’s centralized review process. In lung cancer, the proposed new indication

The expanded indication of Kyprolis is for these patients who have received at least one prior therapy. Currently, Kyprolis has accelerated approval in the US to treat patients

The drug is approved for patients with HAP and VAP known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible and methicillin-resistant S. aureus