Scientific Research

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Norwegian Study Concludes Infliximab Biosimilar Not Inferior To Remicade

A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that...more

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more

Florida Appellate Court Reverses Verdict Against Valve Manufacturer in Asbestos Case - Decision: Trial Court Abused Discretion in...

Manufacturers of products that contained chrysotile asbestos won a major victory in Crane Co. v. DeLisle on Sept. 14, 2016, when Florida's Fourth District Court of Appeal (Fourth DCA) reversed a verdict entered against a...more

Researchers question FDA cancer experts’ ‘revolving door’ with Big Pharma

The numbers are small but the implications significant. A pair of academic researchers has tossed a conflict-of-interest grenade in the laps of the leaders of the federal Food and Drug Administration. Is there too much of a...more

Is a Consumer Trade Association’s Speech Covered by the DC Anti-SLAPP Act?

When a consumer trade association “speaks” about the health effects of a product, is its speech on an issue of public interest, and thus within the scope of the DC anti-SLAPP statute, or is it in furtherance of the...more

NLRB Decides Private University Teaching and Research Assistants Can Unionize

Continuing a recent trend of upending long-standing decisions, the National Labor Relations Board ruled yesterday that student teaching and research assistants at private colleges and universities are statutory employees who...more

NLRB Classifies TAs as Employees

The NLRB chose not to interfere with collegiate football. Northwestern University, Case 13-RC-121359 (August 17, 2015). Collegiate teaching assistants, though, are another thing. In Columbia University, Case 02-RC-143012...more

NLRB Declares Student Assistants Can Unionize

The National Labor Relations Board today opened the door for further unionization efforts at institutions of higher education by finding that student assistants are employees and therefore eligible for union organizing. Its...more

JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research. This move is expected to expand and diversify the supply of marijuana for...more

Researchers Retract Findings Regarding the Health Risks of “Fracking”

On March 26, 2015, nine researchers published a study in the Environmental Science and Technology journal entitled “Impact of Natural Gas Extraction on PAH Levels in Ambient Air.” The study concluded that there may be a link...more

Food and Beverage News and Trends - July 2016 #2

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape....more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

Silly chocolate milk ‘study’ leaves Terps looking like health information twerps

The University of Maryland has taken a hit to its credibility as a major research institution-and for one of the silliest reasons possible: The Terps, officials have conceded, showed almost no internal rigor nor basic...more

Weighing risks and benefits: Cannabis use and metabolic syndrome risk

Metabolic syndrome is a group of risk factors (usually said to include large waistline, high triglycerides, low HDL cholesterol, hypertension, and high fasting blood sugar) that are associated with coronary artery disease,...more

“Science for Sale” Investigation Exposes “Rented White Coats”

One of the foremost father figures in the history of medicine famously said, “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.” Hippocrates, the ancient Greek...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

Proceedings Available on 2015 U.S.-EU Joint Workshop on Bridging NanoEHS Research Efforts

In December 2015, the proceedings from the March 12-13, 2015, U.S.-European Union (EU) joint workshop on “Bridging NanoEHS Research Efforts” were posted online. The workshop was sponsored by the European Commission (EC) and...more

HHS Recognizes Changing Environment of Research: Still Time to Comment

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more

Does This Year’s Nobel Prize in Economics Suggest Any Lessons Regarding the Regulation of the Consumer Finance Industry?

On Monday October 12, 2015, Professor Angus Deaton won the Nobel Memorial Prize in Economic Science. Professor Deaton’s work focuses in part on consumer behavior, and, more specifically, on techniques used by researchers for...more

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

What To Do About Junk Science That’s Published?

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

Ethanol Mandates under RFS and EPA’s Lifecycle GHG Analysis

In a settlement with the American Fuel & Petrochemical Manufacturers (AFPM) and the American Petroleum Institute (API), the U.S. Environmental Protection Agency (EPA) agreed to set renewable fuel obligations for calendar...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

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