The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

Massive Talc Verdicts Will Encourage More Investment in the Litigation Industry Related to Asbestos
01 August 2018
Massive Talc Verdicts Will Encourage More Investment in the Litigation Industry Related to Asbestos

In September, 2016 the firms of LSP Group, Innovative Science Solutions, and Assured Research collaborated to produce our second, in-depth and multidisciplinary analysis of the changes to and new directions in asbestos litigation. Read more

FDA Advisory Committee Against Extended Release Oxycodone Capsules
28 July 2018
FDA Advisory Committee Against Extended Release Oxycodone Capsules

On June 26th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety. Read more

FDA Advisory Committee Opposed to Buprenorphine Sublingual Spray
27 July 2018
FDA Advisory Committee Opposed to Buprenorphine Sublingual Spray

On May 22nd, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management. Read more

FDA Advisory Committee Votes in Favor of  WAYLIVRA (volanesorsen)
27 July 2018
FDA Advisory Committee Votes in Favor of WAYLIVRA (volanesorsen)

On May 10th, 2018 the Endocrinologic and Metabolic Drugs Advisory Committee met to review new drug application (NDA) 210645. Read more

FDA Advisory Committee Against InfaCare Pharmaceutical Corporation’s Stannsoporfin
25 July 2018
FDA Advisory Committee Against InfaCare Pharmaceutical Corporation’s Stannsoporfin

On May 3rd, 2018 a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. Read more

FDA Advisory Committee Split on Indications for Achaogen’s Plazomicin
24 July 2018
FDA Advisory Committee Split on Indications for Achaogen’s Plazomicin

On May 2nd, 2018 the Antimicrobial Drugs Advisory Committee convened to review new drug application (NDA) 210303. Read more

FDA Advisory Committee Unanimously Supports SIGA Technologies’ Tecovirimat
23 July 2018
FDA Advisory Committee Unanimously Supports SIGA Technologies’ Tecovirimat

On May 1st, 2018 the Antimicrobial Drugs Advisory Committee reviewed the new drug application (NDA) 208627 for SIGA Technologies’ tecovirimat. Read more

FDA Advisory Committee on the Safety of Celecoxib, Naproxen and Ibuprofen
22 July 2018
FDA Advisory Committee on the Safety of Celecoxib, Naproxen and Ibuprofen

On April 24th - April 25th, 2018 a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Committee convened to review supplemental new drug application. Read more

FDA Advisory Committee in Favor of 2 mg dose and Opposed to 4 mg dose of Eli Lilly’s Baricitinib
21 July 2018
FDA Advisory Committee in Favor of 2 mg dose and Opposed to 4 mg dose of Eli Lilly’s Baricitinib

On April 23, 2018 a meeting of the Arthritis Advisory Committee took place to review new drug application (NDA) 207924 sponsored by Eli Lilly and Company. Read more

FDA Advisory Committee Unanimously in Favor of GW Pharmaceuticals’ Epidiolex
20 July 2018
FDA Advisory Committee Unanimously in Favor of GW Pharmaceuticals’ Epidiolex

On April 19th, 2018 the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) convened to review new drug. Read more

The Promise of Biosimilars
20 July 2018
The Promise of Biosimilars

What is the role of biosimilars in the biologics market? How do they effect patients, providers...etc? Read more

Litigation in the Pipeline for Liquid Filled Intragastric Balloon Systems?
02 July 2018
Litigation in the Pipeline for Liquid Filled Intragastric Balloon Systems?

This post was authored by Sai Gandhe and Giovanni Ciavarra, PhD. Sai is a summer intern at Innovative Science Solutions and a senior at Case Western Reserve University studying systems biology and business management. Read more

Genomics as an Insurance Claims Management Tool
25 June 2018
Genomics as an Insurance Claims Management Tool

This article was co-written with William Wilt, President of Assured Research, a research and advisory firm dedicated to delivering highly customized, actionable research and analysis to insurance and investment professionals. Read more

Biosimilars Approval: Opportunities and Challenges
14 June 2018
Biosimilars Approval: Opportunities and Challenges

Biosimilars (also called follow-on biologics) are biologics medicines that are “highly similar” to an FDA-approved biological product, known as a reference product. Read more

All Mesothelioma Cases Are Not Caused by Asbestos
05 June 2018
All Mesothelioma Cases Are Not Caused by Asbestos

Ask any seasoned lawyer how he or she plans to defend their next asbestos mesothelioma case and you are very unlikely to hear that general causation will be at the heart of their strategy. Read more

The Meso Gene
29 May 2018
The Meso Gene

The ongoing revolution in genomic science is having an impact on many facets of modern life, including toxic tort litigation. Read more

Biosimilar Patent Litigators Can Benefit from the Right Consulting and Testifying Experts
29 May 2018
Biosimilar Patent Litigators Can Benefit from the Right Consulting and Testifying Experts

The commercialization of biosimilars was enabled by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 which was signed into law on March 22, 2010 as part of the Patient Protection and Affordable Care Act. Read more

Opioid Litigation – The Defense Perspective [Download Conference Presentation Slides]
23 April 2018
Opioid Litigation – The Defense Perspective [Download Conference Presentation Slides]

The opioid litigation landscape continues to evolve, with over 200 lawsuits currently consolidated in the multidistrict litigation (MDL), In re: National Prescription Opiate Litiga­tion, MDL No. 2804, in the Northern Dis­trict of Ohio and being overseen by U.S. Read more