Policy
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Evotec SE will report its financial results for the first quarter of 2019 on Tuesday, 14 May 2019.
PDC*line is a potent, scalable and versatile professional antigen-presenting T-cell with great potential for treating a range of cancers
Strong Crysvita® (burosumab) Launch Continues with Approximately 730 Patients on Reimbursed Commercial Therapy in the United States
Over and over there are reports about the increasing rise of antibiotic resistant bugs. Even as the number of resistant bacteria increases, the number of companies developing new types of antibiotics is decreasing.
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.