Just as Emergent BioSolutions looked to be making some headway in course corrections following a production mishap that ruined millions of doses of Johnson & Johnson’s COVID-19 vaccine, new information indicates the Maryland-based company sought to hide the deficiencies from federal regulators, all while touting its manufacturing capabilities, according to a BioSpace article.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture, and may inadvertently remove medications that simply can’t complete confirmatory trials within the narrow timeframe allowed.
The Democratic-controlled U.S. Senate on December 8 approved a Republican measure that would overturn President Joe Biden’s Covid-19 vaccine-or-test mandate for private businesses, with two Democrats joining Republicans to back the initiative.
Democratic Party lawmakers holding up proposed drug pricing reforms are among the largest beneficiaries of the pharmaceutical industry’s push to stave off price cuts, a Reuters analysis of public lobbying and campaign data shows.
The U.S. House Judiciary Committee voted on Sept. 29 to approve three bills to stop practices drugmakers use to raise prices and fend off competition, including a bill to ban the tactic of paying generic companies to delay bringing cheaper versions of their medicines to market.
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
Three U.S. senators – Republican Roger Wicker of Mississippi, Democrat John Hickenlooper of Colorado and independent Angus King of Maine – disclosed on Aug. 19 they had tested positive for Covid-19.
President Joe Biden ordered aides to find answers to the origin of the virus that causes Covid-19, saying on May 26 that U.S. intelligence agencies are pursuing rival theories potentially including the possibility of a laboratory accident in China.
AbbVie exploits the U.S. patent system to push up prices for the company’s Humira rheumatoid arthritis drug and cancer medicine Imbruvica, according to a U.S. House of Representatives Oversight Committee staff report on May 18.
U.S. lawmakers from both parties and both houses of Congress introduced eight antitrust bills aimed at tackling the problem of high and rising drug prices, including bills to stop brand name drug companies from paying generic firms to stay off the market.