Randi Hernandez, MS, Associate Editor/Online

Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product.

Aimee Tharaldson of Express Scripts explains why some hepatitis C patients who do not have signs of active disease may want to wait to receive treatment until later this year and early next year, when the FDA is expected to approve sofosbuvir and simeprevir for the treatment of this condition.

Manufacturing patents will play a larger role than molecule patents within the biologics development process, and these will also be a factor in terms of bringing complex products to market, argued Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.

Dr. Morrow spoke on a panel last month with other representatives from Pharma at the Therigy Specialty Pharmacy Congress in Orlando, Florida. Here are some of the most notable comments he contributed to the discussion surrounding pharmaceutical manufacturers' outlook on specialty pharmacy.

Last year there were 11 new cancer drugs approved, and so far this year, 6 oncology medications have been approved, notes Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics, Express Scripts.

The process of adding biosimilars to formularies will be much more rigorous than what the industry is accustomed to seeing in the generic molecule space, asserted Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.

We will see a new wave of oral antiviral hepatitis C medicines hitting the market towards the end of this year and the beginning of next year, noted Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics, Express Scripts.

Specialty Pharmacy Times spoke to Peter Wickersham, senior vice president, cost of care at Prime Therapeutics, to help us highlight the key points of the 2013 Specialty Drug Trend Insights report and its implications for the future of specialty spending.

The changing health care environment and the integration of specialty pharmacies into health systems were the biggest themes during one of the liveliest panels at the Therigy conference last month in Orlando, Florida.

Steven Lucio of Novation discusses why now is the time for pharmacists to educate themselves about biosimilars and the complexities surrounding biologic manufacturing.

Cultivating a career in specialty pharmacy has never been more exciting.

Mitchell Katz, PhD, executive director, medical research operations at Purdue Pharma L.P., explains the function of a Contract Research Organization (CRO) and its role in drug development.

Data presented by Gary Rice of Diplomat Specialty Pharmacy at the 2013 Academy of Managed Care Pharmacy Nexus meeting suggest that partial-fill strategies for specialty pharmaceuticals produce a sizable decrease in total spend.

In a session at the 2013 Academy of Managed Care Pharmacy Nexus meeting, Aimee Tharaldson, PharmD, identified the top specialty drugs in the pipeline and highlighted the most recent therapeutic trends within the inflammatory conditions class.

Formal oncology clinical practice guidelines are not as reliable as some may think, suggests a study presented at the 2013 Academy of Managed Care Pharmacy Nexus meeting.

During AMCP Nexus, we spoke to Beckie Fenrick, pharmacy practice leader at Stoney Hill Partners and Cambridge Advisory Group, about 340B, copay cards, integrating the pharmacy and medical benefits, and potential problems regarding site-of-service optimization. Listen to the audio now!

Leigh Ann Bruhn, director of Avalere Health, notes that limited distribution for specialty pharmaceuticals can improve a manufacturer's data capture capabilities.

A good response to tumor necrosis factor inhibitors taken to treat rheumatoid arthritis comes along with the added benefit of reduced risk of acute coronary syndrome, a study finds.

As the popularity of copay cards for expensive specialty medications increases, health plans are devising new ways to steer patients into using more cost-effective options.

In this video, Todd Speranzo of Avella talks about how to create video content that is compelling to patients.

In this video from the 2013 Armada Specialty Pharmacy Summit, Mark Zitter of Zitter Health Insights discusses stakeholder views on copay cards.

Specialty Pharmacy Times spoke with Eric Sredzinski, PharmD, AAHIVE, vice president, clinical affairs at Avella, to find out more about their adherence initiative with Novartis and how the GlowCap can help optimize patient health.

Secukinumab is the first therapy that selectively targets IL-17A in psoriasis to complete a Phase III trial.

Amid legislative shutdown, some drug review operations tied to residual user fees continue, but all nonemergency activities related to biosimilars have been suspended indefinitely.

Today, more than 30 pharmacy organizations across the globe will go on Twitter for American Pharmacists Month.

Manufacturers often select their specialty drug distribution strategy based on the level of REMS reporting required by the FDA. What are some things keeping specialty pharmacies and manufacturers from collecting the data they truly want?

Health care reform will undoubtedly change the way specialty drugs are managed within the distribution supply chain, and specialty pharmacy providers may soon be competing with hospitals for patient share.

Seniors have medication needs that cannot sufficiently be met by mail-service pharmacy, a recent study in the Journal of Managed Care Pharmacy suggests.

New online learning tools aim to educate users about crucial pharmaceutical industry topics in 45 minutes or less.

The National Psoriasis Foundation Medical Board released a statement supporting the prohibition of biosimilar substitution pending the fulfillment of 7 key measures.