Policy
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
Representatives from five of the nation’s biggest pharmacy benefits manager companies faced members of Congress on Tuesday as lawmakers continue to press pharma players on the high costs of prescription drugs in the United States.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
The distinct roles of these immune cells opens the possibility of new treatments for human inflammatory diseases
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Zogenix said the FDA determined that the NDA, which was submitted in February, was not “sufficiently complete to permit a substantive review.”
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
Eisai Co., Ltd. has announced that its in-house discovered fibroblast growth factor receptor tyrosine kinase inhibitor E7090 has been granted the SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion.
Activities held in partnership with Dubai Health Authority
Since reports surfaced that Martin Shkreli used a contraband cellular phone to conduct business from behind bars, the controversial biotech bad boy investor has not been heard from. And it may be because he is currently in solitary confinement.