January 2016- Volume 12, Issue 1

January 2016

In this Issue

Commentary

A very busy 2016? The intersection of M&As and personalized medicine

A very busy 2016? The intersection of M&As and personalized medicine

M&As are going strong and personalized medicine is a growing force; the two are not always intertwined, but in 2016 things may shift toward them being more so than they have been

Out of order: Avoiding extremes

Out of order: Avoiding extremes

We must strive to avoid getting swept up in hype and then forget or minimize existing limitations and challenges as we try to turn exciting discoveries into life-altering products and services

Clinical Trials

CluePoints not ‘clueless’ when it comes to RBM solutions

CluePoints not ‘clueless’ when it comes to RBM solutions

Company initiates collaboration with Widler & Schiemann on risk management in trials

Initial data for IMO-8400

Initial data for IMO-8400

Idera Pharmaceuticals reports positive data from ongoing Phase 1/2 clinical trial of toll-like receptor in patients with Waldenström’s macroglobulinemia

Survey reveals majority of life-sciences companies lack automated processes

Survey reveals majority of life-sciences companies lack automated processes

Industry leaders are adopting ‘best of breed’ applications in eClinical stack to speed clinical trials

Relief in sight with FDX104?

Relief in sight with FDX104?

Phase 2 data is positive for Foamix’s acneiform rash treatment

Business & Government Policy

AstraZeneca makes $575M deal for Takeda's respiratory business

AstraZeneca makes $575M deal for Takeda's respiratory business

Deal, which is one several at year’s end, includes expansion of rights to roflumilast, the only approved oral PDE4 inhibitor for COPD

On the cutting edge

On the cutting edge

A roundup of instrumentation, software and other tools and technology news

Hyped for HBV

Hyped for HBV

Johnson & Johnson acquires Novira Therapeutics and HBV portfolio in year-end deal

FDA beats the averages on approvals

FDA beats the averages on approvals

FDA’s Center for Drug Evaluation and Research approves 45 novel new therapies in 2015

Research & Development

Cold facts

Cold facts

Oregon team refines cryopreservation technique

Opening access to ‘vital’ cell lines

Opening access to ‘vital’ cell lines

Michael J. Fox Foundation looks ‘back to the future’ toward a speedy cure for Parkinson’s disease

Dealing across the coasts

Dealing across the coasts

N.J.-based Worthington and San Diego-based Cytori ink distribution deal for GMP enzyme

A gut-check for answers

A gut-check for answers

New study reveals why the gastrointestinal microbiota affects disease

Preclinical

Oncology therapeutics on the move

Oncology therapeutics on the move

Sunesis is advancing its BTK and PDK1 inhibitor programs to aid cancer patients

Twice as nice

Twice as nice

OncoMed’s preclinical comparison study shows improved antitumore, immune responses for bispecific antibody

NanoBio chlamydia vaccine prevents PID in mice

NanoBio chlamydia vaccine prevents PID in mice

Nanoemulsion adjuvanted vaccines demonstrate positive preclinical results in genital herpes, HIV and chlamydia

Contract Services

A cancer antibody with more punch

A cancer antibody with more punch

Zymeworks contracts ProBioGen for bispecific GlymaxX antibody cell line development to enhance ADCC potency of antibody

Vetter establishes Japan office to bolster Asian inroads

Vetter establishes Japan office to bolster Asian inroads

Company’s second office in the region will strengthen customer relations and help develop new business among emerging and established Japanese companies

Two for tissues

Two for tissues

ReproCELL acquires life-sciences CRO Biopta

Discovery

Transformative therapy

Transformative therapy

Collaboration focuses on molecular target for unmet medical need

Uniquely human gene variants protect older adults from cognitive decline

Uniquely human gene variants protect older adults from cognitive decline

UC San Diego School of Medicine researchers detail gene variants that convey protection against neurodegenerative and cardiovascular diseases

Cracking the code of CFTR

Cracking the code of CFTR

TSRI scientists find crucial disease-specific protein interactions in cystic fibrosis

Novel drivers of clinical outcomes uncovered in multiple myeloma

Novel drivers of clinical outcomes uncovered in multiple myeloma

Multiple Myeloma Research Foundation and GNS Healthcare present data from longitudinal study

Diagnostics

Never leave a cell behind

Never leave a cell behind

Epic Sciences brings its ‘no cell left behind’ technology to partner with Penn Medicine Abramson Cancer Center

Precision medicine unleashed

Precision medicine unleashed

Whole-exome sequencing test reveals untapped therapeutic options

Vectra DA making waves in RA

Vectra DA making waves in RA

Crescendo shares data highlighting the test’s ability to better depict disease activity

Q&A

Q&A: RNA therapies aimed at solving cardiometabolic and lipid disorders

Q&A: RNA therapies aimed at solving cardiometabolic and lipid disorders

DDNews conducts a Q&A with Paula Soteropoulos of Akcea Therapeutics on transforming the landscape of cardiometabolic lipid disorders

Editor's Focus

Still no silver bullet, but progress continues against cancer

Still no silver bullet, but progress continues against cancer

Between the FDA picking up the pace and researchers devoting ever more knowledge and resources, we may start to gain ground in the oncology race
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