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The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which is awaiting an FDA decision on or before Feb. 8.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
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.
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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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Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
BioSpace’s Employment Outlook report investigates anticipated job search activity and hiring outlook in 2024 as well as how the current workforce is currently faring
The blank check company Thursday filed with the SEC for the initial public offering. While a specific business for Helix Acquisition Corp. II has not yet been identified, the fund will target biotech.
Amit Dagar, a former Pfizer employee, was found guilty of insider trading by a federal jury in New York involving clinical trial results for COVID-19 antiviral Paxlovid that he profited from.
From ALS to depression to Huntington’s disease, many neuroscience-focused companies are anticipating key data over the next few months.
The pharma execs may be served with subpoenas to appear before the Senate health committee to explain why their products are much more expensive in the U.S. than in other countries, according to chairman Sen. Bernie Sanders.
Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange.
A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period, according to a new report.
CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.