Food and Drug Administration (FDA)
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Sanofi and Regeneron, following Amgen dropping the price of Repatha in October 2018, have dropped Praluent to $5,850 a year. This is about a 60-percent reduction from the original price for both the 75 mg and 150 mg doses. The new prices will kick in early March.
When the U.S. Food and Drug Administration approved Genentech’s Xofluza, a single-dose treatment for the flu, it was met with great fanfare, particularly in Japan, where the treatment was first discovered.
On Feb. 12, a U.S. Food and Drug Administration (FDA) advisory committee will debate whether to recommend Johnson & Johnson’s esketamine spray for major depression. It may be an uphill battle, although any positive results in this extremely difficult-to-treat patient population will no doubt be taken into account.
Alexander (Sasha) Opotowsky, associate professor at Harvard Medical School and a cardiologist at Boston Children’s Hospital and Brigham and Women’s Hospital took time out to speak with BioSpace about advances in heart health, congenital heart disease (CHD), biopharma, and the Adult Congenital Heart Association (ACHA).
Despite having achieved a record net sales of $477 million driven by the success of its powerhouse medication Adcetris in 2018, as well as a 58 percent increase in sales during the fourth quarter in comparison to the previous year, Seattle Genetics stock fell as the results did not meet analysts’ expectations.
Approval Based on Clinical Data from the PREMIER Trial - New Indication Provides Options for Patients with Small or Medium, Wide-Necked Brain Aneurysms
The U.S. Food and Drug Administration approved the first treatment for acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi’s Cablivi was given the greenlight and will become a cornerstone of the company’s new rare blood disorders franchise.
Thirteen of those were development programs, the remaining 25 research-stage. In September, the company indicated it was on a cost-cutting program, planning to save 1.5 billion euros this year. Of the programs it is dumping, the most prominent is a mid-phase drug for respiratory syncytial virus (RSV), ALX-0171.
Investors are not happy after Austin, Texas-based Pain Therapeutics announced that it was no closer to seeing its drug candidate Remoxy ER, an abuse-deterrent, extended-release gel formulation of oxycodone, approved by the U.S. Food and Drug Administration.
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