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February 15, 2019

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Gilead rocked by phase 3 failure of selonsertib in NASH

A phase 3 trial of Gilead’s NASH prospect selonsertib has bombed. The ASK1 inhibitor was no better than placebo at improving fibrosis, wiping out hopes that selonsertib would spearhead Gilead’s push into a new market.

Top Stories Of The Week

Special Report—FierceMedTech's 2018 Fierce 15

These are the ideas that can move the needle. FierceMedTech’s Fierce 15 class of 2018 is aimed at advancement—whether it’s simply combining new know-how with old methods, making definitive improvements in well-trodden fields, or pushing us to reconsider how far we can reach with the means available today.

Pfizer Japan drawn into valsartan recall after finding API from Mylan is tainted

The global recall of valsartan has now extended to Pfizer and to Japan, via Mylan and India. Pfizer’s Tokyo-based subsidiary said it is recalling from the country five lots of its blood pressure combination drug Amubaro because its API contains impurities that are probable carcinogens.

BMS can breathe easier now: Celgene’s Revlimid has escaped a big patent challenge

When Bristol-Myers Squibb picked up Celgene in one of biopharma’s biggest deals ever last month, investors tagged one big risk: Celgene’s megablockbuster Revlimid faced patent challenges that could take a big bite out of sales. But now, the $9.7 billion multiple myeloma therapy has dodged one of those threats.

Big Keytruda survival win sets Merck up to steal Bristol-Myers Squibb's kidney cancer share

Bristol-Myers Squibb investors have been dreading positive kidney cancer results from archrival Merck for months. And now that they’re here, they might do even more damage to Bristol-Myers’ market share than some industry watchers expected.

Bladder cancer readout sees Nektar shares hit

Nektar has had a mixed few months as data fed through for its lead cancer drug NKTR-214, but new data in bladder cancer should help steady the ship longer term.

J&J picks up robotic surgery maven Auris Health, and founder Fred Moll himself, in $3.4B deal

Johnson & Johnson is diving deeper into robotic surgery with a $3.4 billion agreement to acquire Auris Health, the Silicon Valley designer of endoscopic hardware aimed at lung cancer. The all-cash offer, made through J&J’s Ethicon division, includes additional commitments to milestone payments that could be worth up to $2.35 billion.

An oral insulin delivery system inspired by tortoises

After a century of research, there's still no proven way to give protein drugs such as insulin by mouth, which is considered the holy grail of drug delivery. Now, an MIT-Novo Nordisk team has come up with a pill, inspired by the tortoise, that they say could one day replace injections for diabetes patients.

Sanofi's new chief digital officer joins wave of executives looking to leverage tech for treatments

It's another digital chief for Big Pharma, this time at Sanofi. The French drugmaker tapped its CMO, Ameet Nathwani, as its first chief digital officer, combining the two roles just as it aims to join treatments and technology in the marketplace.

Astellas and Affinivax’s novel pneumococcal vaccine enters human testing

About two years after Astellas and Affinivax joined forces on developing a novel pneumococcal vaccine with eyes on Prevnar 13, the pair has officially entered the clinic and is already using Pfizer's vaccine king as a comparator.

Enrollment Showcase

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Resources

[Whitepaper] Better Market Intelligence With Smart Search

It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies.

[Whitepaper] Managing Demand Uncertainty in Biologics Production

When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need, factoring in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables.

[Whitepaper] RTSM/IRT: A Roadmap For Developing Systems That Address Current Frustrations

92% of survey respondents make changes to their RTSM/IRT systems due to study changes. See what else puts a strain on their clinical trials. Download the Research Whitepaper.

[Whitepaper] Six API Challenges That could be Slowing your Development

Download this whitepaper to learn more.

[Whitepaper] Engaging Organized Customers in the Era of the Quadruple Aim

Explore how the pharma industry can adapt its approach to the changing healthcare marketplace in the era of the Quadruple Aim

[Whitepaper] Clinical Validation of a Powerful Immune Assay for Patient Selection

Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens.

[Whitepaper] Host Cell Protein Analysis in Biologic Drug Development

This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP analysis.

[Whitepaper] Integrating clinical research at the Point of Care—A New Operating Model

Clinical trials take too long and cost too much—here's what needs to change.

[POCKET GUIDE] 3 Steps To Supercharge Your Literature Search

Go from Search to Full-Text Scientific Papers in a Single Click!

[Whitepaper] Achieving launch excellence in the challenging healthcare markets of today

This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets.

[Whitepaper] Liquid Biopsy Investor Toolkit

With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.