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club drug, esketamine must be used in a doctor’s office or medical facility. The drug has a wholesale cost of $590 to $885 per dose. Here’s more from Stat.
—U.K. clinicians reported that an HIV patient has gone 18 months without signs of the virus in his blood. This marks the second time—and the first in a decade—that a stem cell transplant appears to have cleared the virus from an HIV patient. (Clinicians are hesitant to use the word “cured.”) The results were published in Nature.
—Alnylam Pharmaceuticals (NASDAQ: ALNY) reported that givosiran, an RNA interference medicine for the rare genetic disease acute hepatic porphyria, succeeded in a Phase 3 trial, but side effects clouded the results, and shares ticked down 4 percent. Alnylam said it would complete U.S. and Europe approval applications by mid-2019.
—Vertex Pharmaceuticals (NASDAQ: VRTX) reported that a cystic fibrosis treatment cocktail hit the main goals in a Phase 3 study. It’s the second triple combination from the company to succeed in clinical testing, and a remarkable turnaround from the company’s days relying on a doomed hepatitis C franchise. The Boston drug maker says it will decide in the second quarter which of the two combinations it will submit for FDA approval.
—Weeks before an expected FDA approval decision, the agency sent Evoke Pharmaceuticals (NASDAQ: EVOK) a letter flagging problems with Gimoti, a formulation of a diabetic gastroparesis drug, and the nasal-spray device that administers it. Shares of thinly traded Evoke plunged more than 120 percent.
—The Syndax Pharmaceuticals (NASDAQ: SNDX) drug entinostat failed early-stage studies in breast and ovarian cancer. The studies were testing the Waltham, MA, company’s drug in combination with Genentech’s atezolizumab (Tecentriq) and Pfizer’s avelumab (Bavencio).
—-Amag Pharmaceuticals (NASDAQ: AMAG) drug hydroxyprogesterone caproate (Makena) failed a post-marketing study needed to retain approval for reducing the risk of spontaneous preterm birth. The FDA awarded the injectable drug accelerated approval in 2011. But on Friday, Waltham, MA-based Amag said its drug failed to outperform a placebo in the post-marketing study. Amag attributed those results to the enrollment of primarily Eastern European patients, a demographic that’s different than the one in the study used for the drug’s initial approval.
PEOPLE ON THE MOVE
—Following recent positive Phase 2 data for its type 2 diabetes treatment, Zafgen (NASDAQ: ZFGN) has hired a top Biogen executive, Priya Singhal, as head of R&D.
—Alessandro Riva, EVP of oncology therapeutics for Gilead Sciences (NASDAQ: GILD), is leaving to become CEO of a Glenmark Pharmaceuticals spinout.
—As DBV Technologies (NASDAQ: DBVT) prepares to refile for FDA approval of its peanut allergy treatment, the French company is losing chief operating officer Charles Ruban and chief development officer Laurent Martin.
Ben Fidler and Frank Vinluan contributed to this report.
Photo courtesy of the US Department of Agriculture.