August 2014- Volume 10, Issue 8

August 2014

In this Issue

Research & Development

American CryoStem signs up two

American CryoStem signs up two

Company announces agreements with UHV Technologies for cancer research, HIT Hong Kong for cosmetic applications

A candidate for HER2

A candidate for HER2

DepYmed announces validation of Trodusquemine as therapeutic candidate for HER2-positive breast cancer

BioDiscovery awarded NIH SBIR grant to improve TCGA copy number profiles

BioDiscovery awarded NIH SBIR grant to improve TCGA copy number profiles

Huntsman Cancer Institute at the University of Utah selected to assist in developing and validating new product to improve the copy number variation data from The Cancer Genome Atlas

Merck and Mersana ‘flex’ their muscles

Merck and Mersana ‘flex’ their muscles

In new collaboration, the partners will work together to develop next-generation ADCs

Discovery

Forging a ‘deal of complementarity’

Forging a ‘deal of complementarity’

Evotec and Fraunhofer collaborate in joint drug discovery programs

It’s all academic

It’s all academic

Alzheimer’s disease DNA-sequencing project receives a $24-million boost

Just a gut feeling

Just a gut feeling

Janssen R&D, with trio of business and academic partnerships, researches microbiomes for treating IBD, gut diseases

Trio unite against epilepsy

Trio unite against epilepsy

Intellimedix, Pfizer and Epilepsy Foundation seek a drug discovery platform

Targeting adenocarcinoma

Targeting adenocarcinoma

Genomic sequencing of lung cancer reveals novel mutation and potential therapeutic pathway

Commentary

Guest Commentary: New trend in regulatory affairs consulting delivers reduced costs and improved processes

Guest Commentary: New trend in regulatory affairs consulting delivers reduced costs and improved processes

Matthew Weinberg, CEO of The Weinberg Group, discusses how small- and mid-size pharma and biotech companies in particular can benefit by outsourcing their regulatory affairs work

Commentary: Debunking the myths of treating hepatitis C

Commentary: Debunking the myths of treating hepatitis C

The Pharmaceutical Research and Manufacturers of America (PhRMA) tries to clear the air of what it sees as major misconceptions around hepatitis C therapeutics

Clinical Trials

Cancer progress for Merrimack

Cancer progress for Merrimack

Phase 3 study of MM-398 combination therapy sees improved overall survival in pancreatic cancer

Threshold for success

Threshold for success

Prodrug could revolutionize hypoxic tumor therapy

Magic bullet?

Magic bullet?

Natural substance could be real cure for AIDS, says Hemispherx

Building a bridge

Building a bridge

Acquisition of NIH sickle cell drug candidate by Baxter could start to close gap between rare diseases and cures

An antidote for Factor Xa inhibitors

An antidote for Factor Xa inhibitors

Portola Pharmaceuticals will partner with Daiichi Sankyo for Phase 3 studies of andexanet alfa for anticoagulant patients

Business & Government Policy

Shire saga comes to a close

Shire saga comes to a close

Irish biopharmaceutical giant agrees to $54.8-billion deal

Salix Pharmaceuticals exercises an inversion

Salix Pharmaceuticals exercises an inversion

Company to combine with Cosmo Technologies to form Salix Pharmaceuticals plc

European Commission fines six companies

European Commission fines six companies

Servier and five generic companies hit with nearly $574 million in penalties for curbing entry of cheaper versions of antihypertensive medicine

Shimadzu and Indigo BioSystems begin their ASCENT

Shimadzu and Indigo BioSystems begin their ASCENT

Companies will partner to leverage power of automated solution, unlock clinical data and accelerate LC-MS/MS workflows

M&A watch: AstraZeneca and Allergan still in play

M&A watch: AstraZeneca and Allergan still in play

As AbbVie seals the deal with Shire for an acquisition, Valeant still struggles with its hostile takeover of Allergan and market-watchers wait to see if Pfizer will set its sights on AstraZeneca again

Regulatory Updates

Regulatory Updates

A roundup of recent news around designations, approvals and patent activities globally

Preclinical

Preclinical potential

Preclinical potential

Alnylam’s investigational RNAi therapeutic demonstrates up to 98.7-percent knockdown of serum C5

Becoming a master of the domain

Becoming a master of the domain

Domainex breathes easier after lead compound in preclinical COPD model proves potent

Cells across the sea

Cells across the sea

International Stem Cell Corp. finds potential for its stem cells in Europe, Asia

Taking funding to the web

Taking funding to the web

Batu Biologics passes halfway point in crowdfunding goal

Special Reports

Diagnostics

Spotting Alzheimer’s early

Spotting Alzheimer’s early

Proteome Sciences, King’s College London take one small step toward overcoming early-onset Alzheimer’s by 2025

Biomarker with promise

Biomarker with promise

Merrimack Pharmaceuticals identifies potential biomarker and treatment for multiple cancers, prepares diagnostic assays for future studies

DNA leading the way

DNA leading the way

AutoGenomics and Genomas partner to develop DNA-guided diagnostic systems

Seeking a partner

Seeking a partner

Okayama University research opens potential for non-invasive ‘liquid biopsy’ method to capture circulating tumor cells

Q&A

Q&A: Strengthening hopes in cancer -- Immunology and combination therapies

Q&A: Strengthening hopes in cancer -- Immunology and combination therapies

A talk with Dr. Edward Bradley of MedImmune about his company’s role in the AstraZeneca family and the place MEDI4736 potentially holds within the overall pharmaceutical franchise

Editor's Focus

Editor's Focus: Topic of cancer

Editor's Focus: Topic of cancer

After several editorials that have been somewhat (or more than somewhat) critical of certain aspects of the pharma and biotech business, DDNews' chief editor shares some good news in the world of oncology therapeutics
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