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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Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
The move by the 15 states’ attorneys general comes about a month ahead of a court hearing set for Aug. 5.
The two companies said a booster dose given six months after the second dose had a consistent tolerability profile while still creating high immune responses against the Alpha and Beta variant.
The two were charged with conspiracy to commit trade secret theft and wire fraud, international money laundering and obstruction of justice.
Following a manufacturing mistake that left Emergent BioSolutions with a botched batch of Johnson & Johnson’s COVID-19 vaccine, Emergent is now facing a shareholder lawsuit accusing the company of insider trading.
The WHO is calling for manufacturers to cut prices and increase the availability of supplies to low- and middle-income nations to parts of the world where COVID-19 continues to surge.
bluebird bio is hitting back at Spark Therapeutics over the use of the word “spark” involving the company’s “Be the Spark” campaign against sickle cell disease.
Continuing studies and news about COVID-19 around the world keeps coming in. Here’s a look.
The board strongly believes that Walmsley is the correct leader for the pharmaceutical business arm of GSK, which is being referred to as New GSK.
After the July 4 holiday, the U.S. FDA has several things on their immediate calendar, including a couple target action dates and an advisory committee hearing. Here’s a look.