News

When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

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

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

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

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

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

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.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

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

Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.

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

Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.

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.

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

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

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.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

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

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

Reference product manufacturers and trade groups support automatic medication switches in new biosimilar “compromise” terms.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.