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The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

Microchannels show potential benefits for inertial cell sorting and for introducing genetic material into cells.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

As part of the partnership, Zenith Technologies’ methodologies, systems, and libraries will be offered as a service to GE Healthcare’s clients in bioprocessing.

The company announced that it received EXCiPACT certification in December 2015.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

Sandoz Industrial Products GmbH will be renamed Corden BioChem and will be associated with the CordenPharma Group, ICIG’s pharmaceutical platform.

The companies will merge to create a gene therapy biologics CDMO.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.

Although many immunotherapies focus on tumor-associated antigens, many of the peptide targets on the surface of cells have not be validated.

Adheren relies on chemical modifications, rather than genetic engineering, to create its cell-based immunotherapies.

The service center will act as a hub for delivery, maintenance, calibration, and technical support for the company.

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.

The new research scheme will be based in GE’s Turkey-based innovation center, and will help support the region’s biopharmaceutical industry.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The commercial partnership aims to use digital health tools including sensors, apps, analytics, personal feedback, and education to assist patients in monitoring respiratory diseases.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

A $1.1-million NSF grant awarded to Advanced Polymer Monitoring Technologies will be used for the development of a characterization technology for monitoring aggregation in biopharmaceuticals.

The report examines the increased number of companies cited by regulators for data integrity issues.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.