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January 12, 2018

Today's Rundown

Featured Story

Concert rethinks R&D plans after loss in Incyte patent case

Concert Pharmaceuticals is reassessing whether to expand CTP-543 into additional indications after its attempt to challenge an Incyte patent failed. The setback leaves Concert committed to taking the drug forward in alopecia areata but uncertain of its future beyond the indication.

Top Stories

Forty Seven lines up Roche as second partner for CD47 cancer immunotherapy

Forty Seven has added Roche to its partner list for its CD47-targeted immuno-oncology candidate, with Roche’s Genentech unit agreeing to sponsor two trials of the antibody in combination with its PD-L1 inhibitor Tecentriq.

Aradigm crashes after FDA panel votes down antibiotic

A FDA expert committee has voted against Aradigm’s inhaled formulation of ciprofloxacin. Most of the panel felt Aradigm failed to provide substantial evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in patients with chronic lung infections.

[Sponsored] INNOVATION BY DESIGN

Astellas, like many of our industry peers, prioritizes innovation. What sets Astellas apart, however, is how we function at the intersection where our “Science First” approach meets the flexibility we’ve built into our innovation infrastructure.

Decoding cancer-linked enzyme could lead to better EGFR cancer drugs

NIH scientists have modeled the 3D structure of DHHC enzymes, which modify nearly 1,000 human proteins, including EGFRs, a family of receptors that are implicated in a range of cancers.

New tools for turning genes into drug factories

Synthetic biologists have long dreamed of designing genetic circuits in the body that can produce drugs in response to environmental cues. But it’s been a challenging task. Now scientists at Rice University say they have created a toolkit of gene “promoters” that can turn genes on and off at command.

Boston Scientific wins FDA clearance for electric pulse system for nonopioid pain management

The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids.

EuroBiotech Report—Novo-Ablynx, Takeda-TiGenix, Scancell-BioNTech, Sanofi-Alnylam and Boehringer

In this week's EuroBiotech Report, Ablynx rebuffs €2.6 billion Novo bid, Takeda inks €520 million TiGenix buyout and more.

FiercePharmaAsia—Takeda deals, blockbuster China nods, Sanofi European generics suitors

Takeda, which just reached a neurodegenrative deal with Denali, is buying up TiGenix; Opdivo and Lynparza are among 16 potential blockbuster nods in China this year; several Indian and Chinese firms are reportedly eyeing Sanofi's European generics unit; plus more news from Asia's pharma industry.

Chutes & Ladders—Pfizer oncology head Liz Barrett jumps ship to Novartis

Novartis poached Pfizer oncology head Liz Barrett, Ed Kaye re-emerged as CEO of genetic disease startup Stoke Therapeutics, Perrigo hired pharma packaging company executive Uwe Röhrhoff as CEO; plus more hirings, firings and retirings throughout the industry.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Marketplace] Asia-Pacific Compliance Training for Life Sciences Professionals

Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics.

[Webinar] How to Prevent, Identify, and Implement a Clinical Trial Rescue

What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? From study delays to quality issues, sponsors can find their studies at risk with no clear solution.

[Whitepaper] Key to regulatory transformation is unified RIM

Expanding into new markets places a spotlight on inefficient processes.

[Whitepaper] Streamline your mAb Intact Protein Characterization: Download App Note

This Agilent intact protein analysis includes:

[Whitepaper] Best Practices for Managing Regulatory Processes 

Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems.

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

Events

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