Opinion &amp; analysis

The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While ‘Wrath’- Behrendt Fumes

In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.

November 26, 2018

The Intersection Between Tech and Pharma Special Report (Part 2. Apple)

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In January 2015, Fortune reported that at $2.9tn, the state of the US healthcare industry is very strong and continues to grow. Additionally, a Top Issues report revealed that 40% of Fortune 50 companies pursued new healthcare partnerships in 2014. Given the rapid change in the healthcare industry over the last few years, it is no surprise that we are starting to see more non-traditional healthcare partnerships, specifically with big tech companies.

January 14, 2016

The Intersection Between Tech and Pharma Special Report (Part 3. Intel, Samsung, IBM, and GE)

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The Intersection Between Tech and Pharma Special Report (Part 3. Intel, Samsung, IBM, and GE)

January 22, 2016

The Knowledge Within: An Interview With Merck KGaA’s R&D Chief

Merck KGaA’s head of global research and development, Luciano Rossetti, sat down with In Vivo to discuss the track the German company is taking toward becoming a major player in global immuno-oncology. Tap in to his insights and opinions in this essential interview.

March 11, 2019

The Next New Thing In FDA Inspections: Poor Root Cause Investigations

As the pharmaceuticals industry gets its issues with data integrity under control, a new challenge has arisen, according to US FDA comments at a recent meeting of the International Society for Pharmaceutical Engineering. Find out how these out-of-specification investigation (OOS) issues are playing out, with expert reporting from Pink Sheet.

January 6, 2019

The Oncology Burden Of Proof: Learning From The PD-1 Market

In Vivo interviews Eva Marchese, VP at consulting group Charles River Associates, for insights into the challenges facing the PD-1/LD1 European market’s reimbursement and access schemes for IO products. Gain insights into the sustainability obstacles for immuno-oncology products in this vital interview.

November 7, 2018

Thinking about using CMMI? Here are tips from the experts

Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.

June 25, 2018

Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat

Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.

August 9, 2019

Top 10 Drugs: Weighing Pharma’s Golden Eggs

A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.

August 6, 2019

Top 20 Pharma Ranks: As Some Move Up, Others Fall Down

Although the ranking of Scrip’s top 100 pharma companies remained largely the same as the previous year, there were some surprising moves up – and down – in rank for major players within pharma. Find out who in the top 20 moved, and in what direction, in this essential resource from In Vivo.

December 13, 2018

Transforming Pharmaceutical R&D with Data

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Ongoing pressures on drug pricing and reimbursement mean that current research and development (R&D) economics are unsustainable. The process of discovering and developing a drug has not fundamentally changed for decades, and on average it still costs $2.6bn and takes over 10 years. Fortunately, tools are emerging to help improve R&D success rates. Most are built on better use of more kinds of data, including using artificial intelligence (AI) to process massive quantities of information that humans cannot manage. Some of these new tools promise cost and time savings of between 20–50%

May 2, 2017

Trump Drug Pricing Plan Includes Part D Surprises, Challenges PBM Business Model

The Trump Administration’s “Blueprint to Lower Prices and Reduce Out-of-Pocket Costs” includes dramatic changes to protected classes, rebates and PBM reimbursement. Discover why the blueprint has industry leaders worried. Explore the implications for biopharmas and PBMs in particular and the healthcare industry in general.

May 11, 2018

Trump’s Drug Pricing ‘Dream Team’ And Prospects For Change

The US Department of Health and Human Services is hoping for stability in its ranks in order to move its drug pricing reform policy forward, according to HHS Deputy Secretary Eric Hargan. Find out more about anticipated personnel adjustments to the HHS in this Pink Sheet article.

November 24, 2018