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ISPE Field-Tests Quality Program
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
AAPS Announces 2018 Slate of Candidates
The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
FDA Approves First Biosimilar to Amgen’s Neulasta
The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
Gottlieb Proposes Modernization of Drug Review Office
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
EMA Recommends Approval of Migraine Biologic
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Hospira Recalls Naloxone Hydrochloride
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
EMA Recommends Four Biosimilars for Approval
The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.
New Research Hub Tackles Access to Vaccines
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.
Lonza Expands Cell Portfolio for In Vitro Testing
Lonza has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.
Lonza to Manufacture TxCell Product
TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.
Anti-methamphetamine Antibody Moves to Clinic
Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
Alcami Announces Deal with New Investors
Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.
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.
