Ignyta’s Neuroblastoma Treatment Receives Orphan Drug Designation; FDA Approves First Ebola Test for Emergency Use

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December 30, 2014

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Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological Indicators
In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

FDA Realigns Drug Inspection and Manufacturing Oversight
Operational changes at FDA and CDER aim to improve global market monitoring.

Drug Scandals Impact Industry in Japan
The spate of drug scandals may alter the relationship between manufacturers and research institutions, and reshape Japan’s clinical research industry.

Ignyta’s Neuroblastoma Treatment Receives Orphan Drug Designation
Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

FDA Approves First Ebola Test for Emergency Use
Roche’s LightMix Ebola test can give results in around three hours.

Teva Announces FDA Approval of Granix for Self-Administration
Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.

More New Drugs and Faster Approvals
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA Approves Genentech’s Combination Leukemia Treatment
When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

FDA Approves Zerbaxa
FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

Protein Sciences Considers Sourcing Flublok From Japan
Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

FDA Approves Opdivo for the Treatment of Melanoma
Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.

Express Scripts and AbbVie Ink Landmark Formulary Exclusivity Deal
Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.

Janssen Beefs Up Antibody Discovery Capabilities through Agreement with Sevion
The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

Cardinal Health to Build Facility to Manufacture Bayer Radioactive Therapeutic Agent
Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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