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Fujifilm Opens Collaboration Center
FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.
Merged Microscope Illuminates Biological Processes In Vivo
National Institutes of Health (NIH) researchers combine two microscope technologies to create sharper, faster images.
Agilent Acquires Genohm to Improve Lab Informatics
Agilent Technologies expects the acquisition to improve its current software portfolio.
Integrated Dissolution Solution for R&D and QC Labs
Mettler Toledo and SOTAX partnered to develop a new dissolution solution system line for R&D and quality control laboratory processes.
Amgen and Harvard Partner on Digital Biology Educational Platform
The Amgen Foundation and Harvard University will develop LabXchange, a free online science education platform that will provide digital instruction and virtual lab experiences.
Rentschler Fill Solutions Announces Agreement for US-Market Drug
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
Ingenza in Collaboration to Recycle CO2 from Bioprocessing Plants
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
FDA Releases REMS Guidance
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
Bayer Gets US Approval for $66-Billion Acquisition of Monsanto
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.
GE and CCRM Partner with DiscGenics on New Cell Therapy
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
FDA Publishes Guidance on the Effects of Drugs on Blood Pressure
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
Data Integrity Failures Found at China Facility
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
WHO Vaccinates Against Ebola with Merck & Co.'s Experimental Vaccine
World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.
Novartis Gains EC Approval for Infliximab Biosimilar
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).
Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing
This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.
Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility
The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities
In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
WuXi Biologics to Invest $60 Million in New Singapore Biomanufacturing Facility
WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.
Vectalys, FlashCell Merge to Form Gene Therapy Company
The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.
Gilead’s Kite Expands Cell Therapy Facilities in US, Europe
The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.
FDA Approves First Preventive Treatment for Migraine
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
Parker Bioscience Expands UK Facilities
Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.
European and Indian Pharmacopoeias Coordinate on Quality Standards
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
FDA Commissioner Puts Branded Companies on Notice
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
China’s Pharma Growth Potential to Drive Attendance at CPhI China
Internationalization and regulatory reform are driving growth and investment China.
Catalent Adds Capacity at Kansas City Clinical Supplies Facility
The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.
FDA Approves Pfizer’s Epoetin Alfa Biosimilar
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
Novartis Acquires AveXis for $8.7 Billion
The acquisition is expected to strengthen Novartis’ gene therapy pipeline.
Apotex Recalls Product Due to Elevated Levels of Impurities
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
