Top News
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 Completes Acquisition of Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.
FDA Approves 35 New Drugs in 2014
FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.
Baxter Enters Agreement to Sell Vero Cell Vaccines Platform
Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.
Legal Immunity Offered to Makers of Ebola Vaccines in the US
US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.
FDA Approves Amgen Drug for Acute Lymphoblastic Leukemia
Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.
Drug Spending Rises
Spending rises on prescription drugs despite overall slow-down in health care outlays.
Sanofi Faces Alleged Kickback Charges
Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.
FDA Issues Formal Clinical Hold on Aldoxorubicin Trials
CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.
First Remicade Biosimilar Hits India
Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.
Novel Technologies Win CPhI Pharma Awards
On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.
