Opinion &amp; analysis

Want To Add A Drug Coating To Your Device? Check FDA’s New Guide

FDA draft guidance on combination products provides some insights, but its seven-page annex provides details on regulatory considerations for adding a drug coating to an existing device. For five common drug-coated-device scenarios, learn whether you can rely on a 510(k) submission. Discover what other related guidance is in the works.

February 5, 2019

Wearables are Transforming R&D and Care Delivery

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Wearable technologies have the potential to transform medicine and the delivery of healthcare more significantly than any other component of the digital revolution – or indeed than many other scientific advances.

June 6, 2016

What Do Cosmetics Reform Campaigners Dream Of At Night? Rep. Schakowsky Just Reintroduced It

Find out more about the proposed The Safe Cosmetics and Personal Care Products Act 2018. This bill would institute a number of reforms for the industry and establish a new set of guidelines for safety, and is very similar to previous proposals for cosmetics reform submitted by Rep. Jan Schakowsky, D-Ill.

September 29, 2018

What Does 2019 Hold For Biopharma?

What will be the biggest trends in biopharma during 2019? In Vivo brings you the predictions of various industry experts, who weigh in on their predictions for what 2019 may hold for R&D, market access, digital and AI, and the organizations and people who play a key role in the industry.

January 23, 2019

What Does It Take To Launch And Lead An Oncology Biotech Today?

Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.

August 12, 2019

What GSK’s Immunology Chief Did Next

Paul Peter Tak, formerly of GlaxoSmithKline, is “following the science.” He’s joined Flagship Pioneering as a venture partner and is already CEO of an “undisclosed biotech start-up operating in stealth mode.” Learn more about Flagship’s approach–creating think tanks to build companies from scratch around important unmet challenges–and why Tak finds that so appealing.

February 5, 2019

What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

Tap into the findings of the latest Regulatory Affairs Professionals Society Overall Compensation & Scope of Practice Survey, a comprehensive study of the salaries, hiring trends, and other noteworthy data for regulatory professionals in 64 countries around the globe.

October 12, 2018

What’s Under The Iceberg: GE Healthcare’s Deep Dive Look At Future Of Gene Therapy

As gene therapy becomes an increasingly prominent area of interest, players are formulating new strategies to enter the marketplace. In Vivo speaks with GE Healthcare’s General Manager of Cell and Gene Therapy for an inside look at the company’s plans to expand into this area.

December 3, 2018

Why Deals Fail: The Reasons May Be Clinical, Economic Or Strategic

Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Looking back at significantly sized acquisitions over just five years reveals that half of 2014’s acquisitions can already be judged as outright failures or, at best, questionable. But some lessons can be learned from dud deals. This article from In Vivo
Examines deal failures, from the most surprising to the most expected, given the level of risk at stake. If past Is prologue, dealmakers would be wise to look back and consider these lessons of the past.

August 1, 2019

You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments

Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.

May 9, 2018