Allison Inserro


House of Representatives Passes Pelosi Drug Bill 230-192

December 13, 2019

The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.

Sanofi to End R&D on Diabetes, Cardiovascular Drugs

December 11, 2019

Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.

Slower Price Growth, Use of Generics Balance Higher Spending on Cancer, Autoimmune Drugs

December 10, 2019

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Nocebo Effect Can Hamper Biosimilar Acceptance, Review Says

December 06, 2019

Interestingly, nocebo effects may also be induced by exposure to information shared online, through social media, through drug advertisements, and advertised descriptions or warnings about health-related conditions. The effect can be profound; the authors said negative expectations underlying nocebo phenomena have been shown to alter activity in certain regions of the brain.

Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar

December 05, 2019

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.

Reports Say Administration May Agree to Democrats' Demands on USMCA Biologic Patent Rules

December 03, 2019

Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.

Report Shows How Much Price of Adalimumab, Insulin Glargine, Varies Globally

November 25, 2019

How much does the price of common drugs vary across the globe? A UK digital healthcare startup collected that information to display the disparities across 50 countries for 13 often-used pharmaceuticals, including adalimumab and insulin glargine.

GAO Report: Reference and Generic Sponsors Look Differently at FDA REMS Enforcement

November 20, 2019

Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.