Bio/Pharma News
Boehringer Ingelheim to Establish Biopharmaceutical Production Facility in Vienna
Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.
Samsung BioLogics Breaks Ground on Third Facility
Samsung BioLogics begins construction on their third facility in Songdo, Korea.
Cellectar Biosciences and Pierre Fabre Form Oncology Pact
The aim of the collaboration is to advance the use of Cellectar’s phospholipid drug conjugate platform for targeted delivery of a selection of Pierre Fabre’s cytotoxics.
Synpromics Collaborates on Gene Therapies
Synpromics announced collaborations with Avalanche Biotechnologies and Applied Genetic Technologies Corporation to use synthetic promoters to develop gene therapies, including adeno-associated virus technology for treating eye diseases.
AstraZeneca Completes Tender Offer For Outstanding ZS Pharma Shares
AstraZeneca announced the completion of a tender offer for all of the outstanding ZS Pharma shares.
AstraZeneca Expands Investment in China
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
AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.
Althea Expands Biological Drug Product Manufacturing Operations
Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.
Assembly Biosciences Reports Successful Clinical Study on Gemicel
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
Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.
FDA Approves Kanuma
FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.
EMA Accepts Sandoz’s Biosimilar for Etanercept
Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.
Amgen Submits MAA to EMA for ABP 501
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
FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.
TxCell Signs Strategic Agreement with MaSTherCell
TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.
Adaptimmune and Universal Cells Collaborate to Develop Allogeneic T-Cell Therapies
Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.
Paragon Bioservices to Develop HIV Vaccine Candidate
Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.
Seqirus Opens Corporate Headquarters in the United Kingdom
Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.
Amgen's Biosimilar BLA For ABP 501 Submitted To FDA
Amgen announced the submission of a BLA with the FDA for ABP 501.
Paras Biopharmaceuticals and Novozymes Set to Collaborate on Osteoporosis Treatment
Paras Biopharmaceuticals and Novozymes will collaborate on the creation of an improved osteoporosis treatment.
Novo Nordisk to Switch to Renewable Energy by 2020
The goal is to have all of Novo Nordisk’s production plants operating on renewable electricity with zero CO2 emissions by 2020.
Hikma Sells Ben Venue Manufacturing Facilities to Xellia
Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.
Pfizer-Allergan Merger Valued at $160 Billion
The proposed merger of Pfizer and Allergan will create a new top drug maker and cut Pfizer’s tax bill with a headquarters move to Ireland.
Charles River Laboratories Acquires Oncotest GmbH
Charles River Laboratories announces the acquisition of Oncotest GmbH.
FDA Approves Darzalex
Lucentis Effective for the Treatment of Proliferative Diabetic Retinopathy
A landmark study by the National Institutes of Health determines that Lucentis is highly effective as a treatment for diabetic retinopathy.
Advaxis Presents New Data at the Society for Immunotherapy of Cancer 2015 Annual Meeting
High-dose axalimogene filolisbac immunotherapy will advance to expansion phase.
The University of Pittsburgh Partners with Biopharmaceutical Company
Roche Downsizes Small-Molecule Manufacturing and Exits Four Sites
Roche will invest in Switzerland but leave sites in Ireland, Spain, Italy, and the US as it focuses on lower-volume, specialized medicines.
TrakCel Ltd. Adds Cognate BioSevices to Connected Services Program