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January 2014 Volume 10, Issue 1

Volume 10, Issue 1 | January 2014

In this Issue

Special Reports

Medicating metabolism

Novel approaches are expanding the focus on both prominent and rare metabolic disorders

Editor's Focus

Warp speed ahead with the new DDNews

The magazine's new chief editor gives you a brief introduction to himself but mostly offers a tour around the new format because in 2014, instead of news sections based on therapeutic, technological and research areas, our sections will be based on the pipeline stages that most of you deal with in your day-to-day work.

Commentary

OUT OF ORDER: Taking a global view

As DDNews Feature Editor Randy Willis notes, he and several others have harped over the years that the needs and practical realities of patients in the developing world are significantly different from those in the developed world. While that statement may sound patently obvious and therefore ridiculous, it has significant implications when it comes to delivering useful and sustainable healthcare, and he tells you why.

Commentary: Federal Circuit enforces written description requirement even for negative limitations and narrower clai

In two recent decisions, different panels of the Federal Circuit reaffirmed the importance of the written description requirement of 35 U.S.C. § 112(a). These cases underscore the importance of the written-description requirement, and suggest that the Federal Circuit may be inclined to reject as invalid broad claims covering solutions to problems not described in the patent.

Discovery

Roche and Molecular Partners ally against cancer

Partnership will combine novel biologics with drug-conjugate technology

Going social for Alzheimer’s research

Growing network gives small biotech and academia better access to CROs

New ALS impact from ImStar

ImStar’s lead candidate derived from withaferin A targets TANA inflammation pathway

Define and regulate

Conference assesses discovery challenges and other issues related to nanomedicines

Versant Ventures expands into Canada

U.S.-based firm to invest in innovative, early-stage drug discovery and accelerate commercialization of scientific research

Clinical Trials

Blood cancer compounds boding well

Novartis announces positive results for cancer compounds for multiple myeloma, leukemia

Jump-starting immunotherapies with Juno

Fred Hutchinson, Memorial Sloan-Kettering, Seattle’s Children launch new company with $120M investment

Antibiotic innovation

Helperby Therapeutics and Cadila Pharmaceuticals collaborate on ‘resistance breaker’ R&D agreement

SINE compound shows promise in blood malignancies

Karyopharm data for first-in-class Selinexor shows effectiveness in Phase 1 study

Intra-Cellular Therapies goes after schizophrenia

Company announces positive topline Phase 2 results for ITI-007

Preclinical

Project A.L.S. announces research effort with Lilly

Pair will look to study cancer drugs that might treat devastating brain disease

Zurich team explores immunotherapy for brain tumors

Promising new approach emerges as researchers combine two compounds in preclinical studies

Getting fired up over FynomAbs

Covagen has announced the expansion of its research collaboration with Tanabe Research Laboratories USA Inc., a fully owned subsidiary of Mitsubishi Tanabe Pharma Corp.

Inovio hopeful about potential MERS vaccine

No vaccine currently exists for disease that so far has demonstrated a 42-percent fatality rate

Instem shows support for SEND

Proper management of SEND information helps sponsors, CROs and regulators to share and analyze study data

Q&A

‘Breathing life’ into analytical data

A Q&A with Ryan Sasaki, director of global strategy at ACD/Labs, and Steve Thomas, an investigator at GlaxoSmithKline

Diagnostics

Pinning down prostate cancer

Vanderbilt University and University of Alberta identify prostate cancer biomarker that may predict patient outcomes

Gaining GI ground with Given Imaging

Covidien to acquire developer of PillCam, an optical capsule endoscope

Choosing controls

ATCC discusses trends and controls in molecular applications at AMP meeting

‘Personalizing’ NGS tools

Cerner and Claritas Genomics will collaborate to advance personalized medicine

Business & Government Policy

Highlights from the pipeline

Thomson Reuters highlights third quarter’s promising drugs to watch

NIH green-lights first batch of Alzheimer’s genomic data

Data release includes genome sequences from 410 people in 89 families

FDA overstepping its bounds?

Agency under some fire for ordering 23andMe to shut down consumer genetic tests

Patent Docs: Patent-eligible subject matter in the district courts

Last month, in a decision by the Northern District of California in Ariosa Diagnostics v. Sequenom, the court granted summary judgment of invalidity for claims directed to non-invasive prenatal diagnosis

Research & Development

Bayer picks up Algeta for $2.9 billion

Looking at potentially billions in milestone and royalty payments, Bayer makes a move to buy its Xofigo partner outright

An oncological group effort

GlaxoSmithKline (GSK) has launched a global consortium consisting of itself and six internationally renowned comprehensive cancer centers based in the United States, Canada and Europe to collaborate on a scientific research network aimed at focusing on oncology clinical trials and combination drug therapies, as well as translational research

January 2014