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.
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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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Bayer said the award conflicts with an April report from the EPA that says glyphosate, the active ingredient in Roundup, is not a carcinogen.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
The new guidance should allow switches from branded products to biosimilars that are alike in safety and efficacy without prescriber approval.
Insys owes more than $240 million in legal-related fees but the company only has about $87 million in available cash.
The two generic drugmakers, along with many others, have been accused of conspiring to inflate the price of more than 100 generic drugs.
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
Companies that generate revenue less than $100 million would not have to undergo regular outside audits.
Johnson & Johnson has lost several major lawsuits over allegations that asbestos in its talcum powder contributes to ovarian cancer.
The company is pledging to support a goal to end HIV in the U.S. by 2030 announced by the president during the State of the Union this year.