Randi Hernandez

The new partnership between NeoStem and Invetech focuses on the development of a closed processing system for cell-based therapy manufacturing.

The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.

Biogen Idec’s investigational monoclonal antibody met its primary endpoints in a recent Phase II for the treatment of acute optic neuritis.

An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.

The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.

In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

Although competing therapies will continue to be released in the immune-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.

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.

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

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

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

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

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

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

The acquisition will enhance Merck's "superbug" medication portfolio.Merck announced Dec. 8, 2014 that it would acquire Cubist Pharmaceuticals for a total transaction value of approximately $9.5 billion, including a little over $1 million in debt. The deal will add to Merck’s portfolio of drugs treating antibiotic-resistant bacteria, such as Cubist’s antibiotic Cubicin (daptomycin for injection), the only approved once-a-day therapy for both Staphylococcus aureus bacteremia and complicated skin and skin structure infections.

Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Biopharma employees report gains in compensation and job satisfaction, as industry growth continues.

Biotech drug manufacturers' emails may have been hacked by individuals with sophisticated investment banking skills, according to a report from the New York Times.

Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.

FDA will delay its decision regarding the new drug application for panobinostat.

The announcement calls attention to another partnership in the growing T-cell receptor engineering space.

Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.