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1. The FDA approved Praxbind (idarucizumab), a reversal antidote for Boehringer Ingelheim’s blood-thinner Pradaxa. The drug is used during emergency situations to reverse uncontrolled bleeding. Boehringer Ingelheim settled thousands of lawsuits involving the blood thinner in 2014, according to The New York Times. Patients and families claimed that BI had failed to properly warn users about the drug’s serious and sometimes fatal bleeding that could not be easily reversed at the time.
2. Valeant CEO J. Michael Pearson told investors that the company expects a new pricing environment in 2016, one that may mean lower drug prices for the entire industry, according to Reuters. “I do think, given that environment, the pricing that pharmaceutical companies will take in the future will be more modest,” he said. Valeant disclosed last week that prosecutors from New York and Massachusetts had begun investigations of the company’s patient-assistance programs and pricing practices.
3. The FDA denied approval of Shire’s dry-eye drug, lifitegrast, requesting additional data for it. Shire CEO Flemming Ornskov expressed disappointment about the agency’s decision but affirmed the company’s plan to launch the drug in 2016, saying it expects that data from a Phase-III trial ending later this year will satisfy regulators.
4. Female-libidio drug Addyi landed on pharmacy store shelves Saturday. The drug’s approval in August was met with controversy over potential side effects and the clinical trial used to substantiate its approval. Many patients may lose interest in the novel treatment due to its interactions with alcohol, Dr. Lisa Dabney from Mount Sinai Hospital told the Associated Press. Valeant is acquiring Sprout, which brought Addyi to market.
5. Publication OncologyLive said it will double its frequency to twice a month, increasing its coverage of research and development in the sector as well as therapeutic strategies. It will also feature articles written by faculty from cancer centers through its partnership program.