Food and Drug Administration (FDA)

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According to Jay Bradner, president of the Novartis Institutes for Biomedical Research, the company is cutting its drug programs from 430 to 340. One of the big areas the company is abandoning is infectious diseases. The decision is a result of a strategic review by Vasant (Vas) Narasimhan, the company’s chief executive officer.
Denmark-based Genmab A/S released topline data from its Phase III MAIA trial of a drug it licensed to Johnson & Johnson’s Janssen Biotech, Darzalex (daratumumab).
FDA
myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician
October was a busy month as multiple biopharma companies made their debut as publicly traded entities and even more companies filed their intentions to go public with an initial public offering. BioSpace takes a look back at some of the key IPOs of the month.
Roche announced positive data from its Phase II STAIRWAY clinical trial. The trial evaluated the extended durability of faricimab (RG7716) in the treatment of neovascular (wet) age-related macular degeneration (nAMD).
With fresh two-year data in hand, Novartis remains focused on seeking regulatory approval for brolucizumab, an ophthalmology drug for the treatment of neo-vascular age related macular degeneration..
Shares of Ann Arbor, Mich.-based Esperion Therapeutics are up more than 7 percent in premarket trading after the company announced on Sunday that planned to seek regulatory approval for its cholesterol-lowering therapy that hit the mark in a Phase III trial.
As the acquisition of Shire by Takeda Pharmaceutical inches forward, global regulatory agencies are signing off on the deal. As the European Commission (EC) conducts a review of the deal, it hit a snag.
Scott Gottlieb, commissioner of the Food and Drug Administration (FDA) is notoriously outspoken. Let’s take a look at some of Gottlieb’s more recent statements.
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