News

Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

This year’s Drug Delivery & Formulation Summit included discussions on solubility, drug penetration, and new approaches to technology.

Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

Actavis announced a senior leadership team comprised of both Actavis and Allergan leaders designed to facilitate dynamic company growth.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

The Singapore Workforce Development Agency collaborated with governmental groups and industry players to develop a plan to supply biologics-manufacturing workforce demand.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

Atlangram will have access to Carlina’s lipid nanocapsule technology platform Soludots under the terms of the agreement.