Randi Hernandez

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

The costs and benefits of integrating modular concepts for on-demand bioprocessing are explored.

The rapid testing of biologic raw materials can lead to greater efficiency.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

The system is compatible with a wide range of industrial CHO cell lines.

The author explores various biocontainers-both old and new-in the single-use space.

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

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 new 2000-L bioreactor will double Rentschler’s single-use manufacturing capabilities.

Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.

As a result of the decision, Sandoz will be able to immediately launch Zarxio, the first biosimilar in the United States.

Under a new agreement, Sigma-Aldrich will be the single supplier for Roche’s Biochemical Reagents product portfolio.

The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

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

Early access to Merck’s Keytruda in the United Kingdom is granted under the UK’s Early Access to Medicines Scheme.

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.