Randi Hernandez

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

The company’s new corporate name will be simply Biogen.

The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Remsima will now be available for patients in 12 additional countries in the European Union.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

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

Although competing therapies will continue to be released in the immuno-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.

The acquisition will enhance Merck's "superbug" medication portfolio.

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

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

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