February 2016 Volume 12, Issue 2
Volume 12, Issue 2 | February 2016
February 2016
In this Issue
Patent News
Scope of safe harbor provisions of Hatch-Waxman Act still unclear
A recent decision provides another example of the court setting forth the contours of the scope of the safe harbor, particularly with regard to activities performed by a generic drug maker to ensure quality control and other aspects of drug making post approvalBusiness & Government Policy
$32 billion for Baxalta
Shire, Baxalta to combine in deal set to create largest rare diseases companyThe toxicity challenge
Current HTS assays may miss chemicals that are metabolized to a more toxic form; government agencies are encouraging solutions10 by 2018
Spark unveils vision of having 10 clinical-stage gene therapy programs by 2018, including one commercial and two in pivotal trialsOn the cutting edge
A roundup of instrumentation, software and other tools and technology newsDiscovery
A ‘gold mine’ of drug targets for autism
UCLA researchers explore uncharted territory in brain cells with mutated genes previously tied to autismA new kind of periodic table
U.K. researchers present Periodic Table of Protein Complexes to better understand and predict proteinsActive on improving trials
ACRES, ActivMed partner for quality and sustainability of clinical research sitesBetting on bispecifics
F-star, AbbVie link up to develop bispecific antibodiesPreclinical
Rising out of the ASH
Immune Design and bluebird bio share preclinical oncology data from annual hematology meetingHep B functionally cured in AIC649 animal studies
Compound in combination therapy induces natural immune response to hepatitis B virusPartnering against pertussis
University of Texas teams with Synthetic Biologics to develop whooping cough treatmentRestoring sight in achromatopsia
Preclinical data evaluating cone-specific promoters further validate company’s technologyQ&A
Q&A: SCILEX pursues responsible pain management
DDNews speaks with Anthony Mack of SCILEX Pharmaceuticals on the management of painFeature
Show Preview: Molecular Med Tri-Con--Visit the preeminent event on molecular medicine
Molecular Medicine Tri-Conference wiill be held in San Francisco and attract several thousand people from several dozen nations to learn about molecular medicine from the angles of diagnostics, genomics, cancer and informaticsEditor's Focus
Get off the fence, FDA, and deal with generic labeling
The FDA did good last year with approvals of novel new drugs and of therapeutics for rare diseases, but it seems to be slacking on updates to generic labeling rulesCommentary
R&D: Risk and delivery in different cultures
The worlds of academia and business view each other with jaundiced eyes at times, but both add value to the research processMarket insight: Prescription medicines-- Costs in context
The pharma and biotech sectors are significant drivers within the U.S. economy and huge contributors to funding and employment in the R&D sector overallNews Briefs
Valneva signs new R&D collaboration with GlaxoSmithKline for the EB66 cell line
Valneva to supply process development services for EB66-based influenza vaccines–Advanced Development program sponsored by the U.S. Department of Health and Human Services—Valneva to receive research fees under the new agreementContract Services
CRO growth
Charles River Labs acquires Germany-based CRO Oncotest GmbH for $36 million, broadens oncology pipelinePairing with Paragon
IAVI contracts with Paragon Bioservices to develop and manufacture an HIV vaccine candidateCrown Bioscience holds symposium; expands in Asia-Pacific region
Symposium focused on precision medicine and translating oncology drug discovery into clinical successResearch & Development
Shank3 side effects
Neuroscientists unravel gene’s role in autism and schizophreniaSimplifying single-cell efforts
Bio-Rad and Illumina partner on single-cell genomics solutionA LEAP forward for autism
The EU-AIMS LEAP study gains EMA support for its biomarkers, study criteriaAddressing chronic inflammatory and degenerative diseases
Fibrocell and Intrexon to develop treatment for arthritis and related conditions through targeted, long-term therapeutic deliverySanofi and Innate Pharma collaborate in immuno-oncology
The companies will apply Innate Pharma’s proprietary technology to develop innovative bispecific antibody formats engaging natural killer cellsDiagnostics
Delving into dark matter
Non-coding RNA molecules in cancer cells trigger immune response because of pathogen-like featuresIllumina’s GRAIL
Sequencing leader launches new company for early cancer detection via blood-based screeningCancer confirmation
California-based MDxHealth says positive data support expanded diagnostic test for prostate cancerFighting HPV to fight cancer
Genticel to evaluate Roche HPV test in preparation for Phase 3 program of GTL001PerkinElmer acquires Vanadis Diagnostics
PerkinElmer acquires Vanadis DiagnosticsClinical Trials
Evaluating eltoprazine
Amarantus reports positive Phase 2 data for eltoprazine to treat Alzheimer’s aggressionHeart smart
iCardiac to take part in Cardiac Safety Research Consortium validation programNew data on colorectal cancer
XBiotech reports additional positive data from Phase 3 European trial of Xilonix in advanced colorectal cancer
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