Top News
BMS Celebrates Superior Overall Survival for Opdivo
Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.
FDA Recommends Approval of First Biosimilar Application
An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.
Janssen May Pay Up to $835 Million for Antisense Therapy
Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.
Drug Approvals Highest Since 1996
In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.
FDA Approves First Ebola Test for Emergency Use
Roche’s LightMix Ebola test can give results in around three hours.
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.
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 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.
EMA Recommends Approval of First Stem-Cell Therapy
The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.
Fujifilm Acquires Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.
Novo Nordisk to Partner with Xencor in the Development of Engineered mAbs
Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.
Dormant Therapies Act Establishes New Class of Pharmaceuticals
The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.
Baxter Enters Agreement to Divest Vero Cell Vaccines Platform
Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.
Tufts’ New Figures on Drug-Development Costs Spark Debate
Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.
FDA to Increase its Ties to China
Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting
IMS: Global Spending on Medicines to Rise 30% by 2018
Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.
Manufacturing Issues Crucial to Combating Ebola
The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.
FDA Requests Comments on Generic Drug Submission Criteria
FDA opens public docket on proposed criteria for “first generic” ANDAs.
