News

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.

The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

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.

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.

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 has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

National Institutes of Health (NIH) researchers combine two microscope technologies to create sharper, faster images.

Agilent Technologies expects the acquisition to improve its current software portfolio.

Mettler Toledo and SOTAX partnered to develop a new dissolution solution system line for R&D and quality control laboratory processes.

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 and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

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.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

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 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.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

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.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.