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Our coverage spans an Adcomm decision on use of phenylephrine, 1Health.io FTC order for failure to protect privacy and security, user fees for OTC monograph order requests and a GDUFA report available. Read More
The U.S. Department of Justice (DOJ) and Danco Laboratories, manufacturer of Mifeprex (mifepristone), have asked the U.S. Supreme Court to review a lower court’s decision to limit access to the abortion drug — a move that could push the case to the front of the court’s docket. Read More
New bipartisan legislation to increase pharmacy benefit manager (PBM) drug price transparency was introduced Friday by the members of the House Energy and Commerce, Ways and Means and Education and the Workforce committees. Read More
Our coverage spans an Abbott acquisition, FDA draft guidances on endogenous Cushing’s syndrome and peptide drug development, EMA guideline revision on clinical trials for depression treatments and a GAO report on drug rebates in Medicare part D. Read More
The price reduction measures in the Inflation Reduction Act (IRA) could result in 79 fewer small molecule drugs or 188 fewer indications and 116 million life years lost over the next 20 years, a study funded by Gilead Sciences revealed. Read More
Pfizer announced Monday that it has reopened its Rocky Mount plant and that efforts to restart production are on track to restart production near the end of the year. Read More
Amgen scored a win in its bid to acquire Horizon Therapeutics with the FTC withdrawing from adjudication of its challenge of the deal until Sept. 18, to allow for discussion of a possible settlement. Read More
CVS Health has launched a subsidiary, Cordavis, to work directly with manufacturers to commercialize and/or co-produce FDA-approved biosimilar products at more affordable prices. Read More