Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
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 U.S. 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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The report, which was issued by the Council of Economic Advisors, pointed to changes in the approval process at the FDA in the approval process of generic drugs has led to greater competition in the marketplace, which has lowered the costs of the medications.
David Johnston, the former chief financial officer of AVEO Oncology, was found guilty of misleading investors about the company’s kidney cancer drug, Tivozanib. Under new leadership, AVEO aims to seek U.S. approval for its kidney cancer drug early next year.
Although the recent mid-term elections had a historic changeover of control in the House of Representatives from the GOP to the Democrats, at least one change in the U.S. Senate has the biopharma industry on edge. Sen. Chuck Grassley (R-Iowa) will take over as head of the Senate Finance Committee.
Ultragenyx Pharmaceutical Inc. today announced that it has completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit a New Drug Application (NDA) to the FDA for UX007 for the treatment of patients with long-chain fatty acid oxidation disorders (LC-FAOD) in mid-2019.
Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Broadens Treatable Patient Population with Thoracic Aortic Disease
After announcing a potential snag with the European Commission last month, Takeda said this morning that it received clearance for its acquisition of Shire. The clearance is conditional on addressing overlaps in the companies’ inflammatory bowel disease businesses.
Seven African American seek unspecified damages over allegations of discrimination at Charleston, S.C. facility.
The Biotechnology Industry Organization (BIO) published the fifth edition of the Building the Bioeconomy report recently. The report studied 28 different indicators and provided analysis and insight into the biotech environment for 33 countries. The goal of the report is to determine how successful biotechnology sectors can be created and sustained.
Retrophin, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new formulation of Thiola (tiopronin) in the treatment of cystinuria.
People with asthma have more treatment choices than ever before and the FDA recently announced approval for the readmittance of Primatene Mist – an over-the-counter epinephrine inhaler.