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IQVIA, the global contract research organization juggernaut, has filed its opposition to the FTC’s proposed preliminary injunction halting its acquisition of Propel Media, the latest in its back and forth with the federal regulator over the latter’s fears surrounding consolidation in the digital healthcare advertising market. Read More
Cisplatin, a commonly used chemotherapy drug prescribed to treat several advanced forms of cancer, is again under production by Accord Healthcare, the FDA said Monday. Read More
Our health care delivery system is changing every day. New medicines, innovative research, new reimbursement policies, doctors burning out and retiring, telemedicine, emergency room delays — these and other changes affect us all. Read More
After committing in March to cut 65 percent off the price of its long-lasting insulin Levemir (insulin detemir), Novo Nordisk has announced that it will discontinue its marketing of the product in the U.S. with supply disruptions beginning as early as January. Read More
The Senate Finance Committee voted 26-0 in favor of the Better Mental Health Care, Lower Drug Cost and Extenders Act which addresses pharmacy benefit manager (PBM) practices that sponsors Sen. Ron Wyden (D.-Ore.) and Sen. Mike Crapo (R.- Idaho) say drive up the cost of drugs. Read More
Biotech products comprise nearly one-third of the $1.5 trillion global pharmaceutical market this year, according to a new Tufts Center for the Study of Drug Development (CSDD) study, with sales growing at five times the rate of traditional pharmaceuticals and hitting $466.3 billion in 2022. Read More
In an agreement worth up to $600 million, Eli Lilly will acquire Beam Therapeutics’ opt-in rights to three of Verve Therapeutics’ cardiovascular disease gene-editing programs in exchange for cash, potential milestone payments and an equity investment. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
Sen. Bernie Sanders (I-Vt.) sent a letter to the HHS Inspector General seeking investigation into an NIH proposal granting an exclusive patent license to an “obscure company linked to a former employee” for a treatment for cervical cancer. Read More
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the FDA’s interest in prohibiting use of a product for an unapproved indication. Read More