Policy
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”
This morning, the White House released its initiative to lower healthcare costs that includes the ability for Medicare to negotiate prices for prescription drugs.
Aubrey de Grey has been accused by two women of predatory behavior, an allegation de Grey denies. SENS has placed him on administrative leave pending further investigation.
Republican Senator Rand Paul is under fire from government watchdogs for failing to properly disclose a $15,000 purchase of Gilead Sciences stock made by his wife last year.
Citing a study from Johns Hopkins University, researchers found that immunocompromised people are 485 times more likely to end up in the hospital or die from COVID-19.
Emergent BioSolutions has approval to resume manufacturing vaccines, but its lawsuit issues haven’t gone away as easily.
The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.
The settlement is a huge development for the class action lawsuit against Takeda, which has been going on since 2016.
AbbVie’s Allergan Aesthetics announced it was buying Soliton in a deal worth about $550 million. Now, the Federal Trade Commission has requested additional information about the deal.
The Trump White House removed Bright from his position at BARDA and reassigned him to a narrower role at the National Institutes of Health.