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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On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
Invitrocue Limited is pleased to provide its Appendix 4C cash flow statement for the quarter ended March 31, 2019 and to announce the appointment of Dr Sharifuddin Abdul Wahab as Global Insurance Advisor.
Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. We want to know your ‘right opportunity’ to consider a new job.
The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
SMA is a severe neuromuscular disease caused by a mutation in the SMN1 gene, which codes for SMN, a protein necessary for motor neuron function.
Curbing the opioid crisis will continue to be a key focus for the FDA. Ned Sharpless talked about new packaging rules that are expected to help stem the concerns about too many opioids on the streets.
The executives, convicted under the RICO Act, were found guilty of bribing prescribers and defrauding insurers in order to increase sales of Subsys, a powerful opioid pain killer intended for use with cancer patients.