14 Dec, 2021 Drug price controls make industry critics feel better, but won’t make people feel healthier By Kirsten Axelsen Please note: Article was first published in The American Enterprise Institute for Public Policy Research In Build Back Better, price...
23 Aug, 2021 An overview of recent FDA activity on materials in medical devices By Mary Gately Christopher Campbell In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...
13 Jul, 2021 Use of preventive care services declined despite expanded coverage By Kirsten Axelsen Key Points: For the privately insured, Medicare, and uninsured populations, the prevalence of the use of preventive care services...
09 Jul, 2021 FDA solicits public comment on adding list of device materials to certain medical device labels By Meagan Self Mary Gately Christopher Campbell Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common...
08 Jul, 2021 DOJ Should Weigh Dismissing Every Nonintervened FCA Suit - Law360 By Courtney Saleski Eric Christofferson Andrew Hoffman When the U.S. Department of Justice chooses not to intervene in a False Claims Act qui tam lawsuit, it should also evaluate whether...
06 Jul, 2021 What COVID-19, Social Issues Mean For Pharma Case Juries - Law360 By Buffy Mimms Rachel Horton Recent surveys of actual and potential jurors suggest that the turbulence of this time will likely affect the attitudes of juries in...
30 Apr, 2021 S 415, narrowing the scope of new chemical entities, is now law: implications for innovator companies By Ellen Scordino Lisa Haile Christian Chessman Jamie Gregorian +1 more... Show less President Joe Biden has signed into law S 415, amending the Federal Food, Drug, and Cosmetic Act to address the scope of what constitutes...
07 Apr, 2021 Patent eligibility in bioinformatics: Federal Circuit affirms rejection of computerized haplotype phasing claims By John McDermott Susan Krumplitsch In a pair of opinions issued in March, the Federal Circuit affirmed two Patent Trial and Appeal Board determinations that...
07 Apr, 2021 Financial Services in the Cannabis Industry: A Compliance Guide By Christopher Gismondi Wendy Michael Jeffrey Hare Interest in cannabis is at an all-time high. In 2020, Americans bought $18.3 billion in cannabis products, a $7.6 billion increase from...
21 Nov, 2019 Will the MORE act make it out of the Senate? By Richard Cheng The MORE Act, introduced in July by House Judiciary Chairman Rep. Jerry Nadler (D-NY), would decriminalize cannabis federally by removing...
17 Nov, 2017 Checkpoint Inhibitors and Diabetes By Lisa Haile PD-L1 and checkpoint inhibitors have been front and center in the media relating to the treatment of cancer. Researches are now looking...
17 Nov, 2017 Regulating High Cholesterol-A Never Ending Challenge By Lisa Haile Researchers from Harvard identified a new protein, Nrf1, which regulates high cholesterol by binding directly to it. This binding prompts...
17 Nov, 2017 Human Embryonic Stem Cells to Treat Blindness By Lisa Haile We have been hearing for a decade about the use of stem cells to create organs and treat diseases. Today, a study showing that hES cells...
15 Nov, 2017 Roche's Alecensa for Lung Cancer Gets a Nod from the FDA By Lisa Haile Roche's Alecensa, a drug for treatment of ALK positive lung cancer, has received a nod from the FDA. While only 5% of lung cancer...
14 Nov, 2017 Sanofi Enters the Race to Develop a New Drug for Multiple Sclerosis By Lisa Haile Sanofi has paid big bucks to enter the race to develop a new drug for MS. The drug was developed by Principia Biopharma and crosses the...