August 2014 Volume 10, Issue 8
Volume 10, Issue 8 | August 2014
August 2014
In this Issue
Special Reports

Special Report on Nanotechnology: Finally beyond the hype?
A decade on, nanomedicines may finally be ready to jump to the foreQ&A

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 franchiseEditor's Focus

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 therapeuticsCommentary

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
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 workBusiness & Government Policy

Shire saga comes to a close
Irish biopharmaceutical giant agrees to $54.8-billion deal
Salix Pharmaceuticals exercises an inversion
Company to combine with Cosmo Technologies to form Salix Pharmaceuticals plc
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
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
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
A roundup of recent news around designations, approvals and patent activities globallyClinical Trials

Magic bullet?
Natural substance could be real cure for AIDS, says Hemispherx
Cancer progress for Merrimack
Phase 3 study of MM-398 combination therapy sees improved overall survival in pancreatic cancer
Threshold for success
Prodrug could revolutionize hypoxic tumor therapy
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
Portola Pharmaceuticals will partner with Daiichi Sankyo for Phase 3 studies of andexanet alfa for anticoagulant patientsDiscovery

Targeting adenocarcinoma
Genomic sequencing of lung cancer reveals novel mutation and potential therapeutic pathway
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
Intellimedix, Pfizer and Epilepsy Foundation seek a drug discovery platform
Forging a ‘deal of complementarity’
Evotec and Fraunhofer collaborate in joint drug discovery programs
It’s all academic
Alzheimer’s disease DNA-sequencing project receives a $24-million boostPreclinical

Preclinical potential
Alnylam’s investigational RNAi therapeutic demonstrates up to 98.7-percent knockdown of serum C5
Becoming a master of the domain
Domainex breathes easier after lead compound in preclinical COPD model proves potent
Cells across the sea
International Stem Cell Corp. finds potential for its stem cells in Europe, Asia
Taking funding to the web
Batu Biologics passes halfway point in crowdfunding goal
Galectin Therapeutics says GR-MD-02 is efficacious in preclinical model of fatty liver disease with fibrosis
Diabetic mice treated for the disease with GR-MD-02 showed reduction in liver weight, liver-to-body weight ratio and plasma triglyceride levelsDiagnostics

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
Merrimack Pharmaceuticals identifies potential biomarker and treatment for multiple cancers, prepares diagnostic assays for future studies
DNA leading the way
AutoGenomics and Genomas partner to develop DNA-guided diagnostic systems
Seeking a partner
Okayama University research opens potential for non-invasive ‘liquid biopsy’ method to capture circulating tumor cellsResearch & Development

Merck and Mersana ‘flex’ their muscles
In new collaboration, the partners will work together to develop next-generation ADCs
American CryoStem signs up two
Company announces agreements with UHV Technologies for cancer research, HIT Hong Kong for cosmetic applications
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
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

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