News

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

Thermo will provide access to its instruments to NIBRT so that the Dublin-based group can generate helpful characterization data.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

The agency cited the company for sterile manufacturing violations.

The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.

The two agencies have set up a working group on involving patients in drug development.

Pressure is mounting to reduce costs and spending on prescription drugs.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

The first-ever use of CRISPR in humans will be evaluated by the National Institutes of Health during a meeting from June 21–22, 2016.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

The ambr 250 is a mini bioreactor system for parallel fermentation or cell culture.

Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.