Genentech granted supplemental approval for Actemra
SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.
The FDA approved Actemra (tocilizumab) for the inhibition and slowing of structural joint damage, improvement of physical function and achievement of clinical response in patients with moderate to severe rheumatoid arthritis. The drug originally was approved as a treatment for RA last year.
“This FDA approval further supports the efficacy of Actemra and follows a similar approval in the [European Union],” Genentech chief medical officer and head of global product development Hal Barron said. “For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals.”
Spectrum, Viropro to develop biosimilar
IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.
Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.
“We are excited at the opportunity to develop our own proprietary biosimilar formulation of rituximab in anticipation of patent expirations for rituximab over the coming years,” Spectrum CEO Rajesh Shrotriya said.
The healthcare-reform bill, which President Barack Obama signed into law in 2010, created a regulatory approval pathway for biosimilars, also known as follow-on biologics, and some analysts expected the Food and Drug Administration to have draft regulations written by the end of this year, though it may take a few years before final regulations appear.
NCPDP summit to explore emerging technologies
SCOTTSDALE, Ariz. — The National Council for Prescription Drug Programs said Wednesday it would host an educational summit on the use and impact of new pharmacy and health-integration technologies next month in Las Vegas.
NCPDP’s educational forum, "Leveraging New Technologies: Impact on the Patient and Healthcare Industry," will take place Feb. 8 at The Cosmopolitan of Las Vegas. The summit will preview the latest innovations that keep the pharmacy industry leading the charge for automation in healthcare to improve quality and efficiency, according to the not-for-profit pharmacy standards development organization.
The summit is intended for pharmacists, pharmacy technicians, payers, HIT vendors, pharmacies, processors, producers, healthcare providers, clinicians, patient advocates and others “interested in taking a closer look at the pharmacy of the future,” NCPDP noted.
Among the topics to be explored:
Technology advancements and emerging technologies;
The evolving role of pharmacists as essential members of the healthcare team;
Mobile health applications and devices and their role in consumer health guidance and engagement; and
Large-scale pharmacy automation that exceeds Six-Sigma accuracy.
Among the featured speakers will be Paul Oesterman, associate professor of pharmacy practice for the University of Southern Nevada College of Pharmacy; Robert Oscar, president of RxEOB; Robert Franz, director of clinical outcomes for Medco; Rick Sage, VP clinical practice for Emdeon; and Wayne Armstrong, SVP for Argus Health Systems. Paul Hooper, VP pharmacy network services for Emdeon, will moderate.
Pharmacists and pharmacy technicians who attend this program will be able to earn continuing education credits provided by AmerisourceBergen. Click here to register.