Bio/Pharma News

AstraZeneca Expands Investment in China

December 16, 2015

Through a strategic alliance with WuXi AppTec and a $50 million facility investment, AstraZeneca plans biologics and small-molecule expansion in China.

AstraZeneca Partners with WCPR to Research Secretome

December 11, 2015

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.

Althea Expands Biological Drug Product Manufacturing Operations

December 10, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Assembly Biosciences Reports Successful Clinical Study on Gemicel

December 09, 2015

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

Mexican Authorities Approve First Vaccine for Dengue

December 09, 2015

Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.

FDA Approves Kanuma

December 08, 2015

FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.

EMA Accepts Sandoz’s Biosimilar for Etanercept

December 08, 2015

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

Amgen Submits MAA to EMA for ABP 501

December 07, 2015

Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.

FDA Releases Interim Response to AbbVie’s Citizen Petition

December 07, 2015

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

TxCell Signs Strategic Agreement with MaSTherCell

December 05, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.