Sandoz Aims to Launch Biosimilar Version of Enbrel

Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Amgen’s Enbrel (etanercept).  Enbrel fights autoimmune diseases by acting as a tumor necrosis factor (TNF) inhibitor to treat inflammatory conditions like rheumatoid arthritis and psoriasis.  Generic production of biologics is tricky because biologics are proteins derived from cells of living organisms and cannot be perfectly duplicated.  Instead, Sandoz hopes to demonstrate the biosimilarity of its product to Enbrel. The new clinical trial will investigate the ability of the molecule to elicit the same immune response in patients with moderate to severe plaque-type psoriasis.  Safety and efficacy will also be determined. Continue reading

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

By Sarah Ray,
Research Analyst

Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought patterns. Patients may also exhibit negative symptoms like those typically associated with depression; things like lack of pleasure in everyday life and lessened emotional range. The World Health Organization estimates that schizophrenia affects up to 24 million individuals globally. In the US, an estimated 1% of the adult population — 2.4 million — have schizophrenia. Continue reading

FDA Closer to Regulating Dr. Smartphone

Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest.  Television ad spending is down as drug companies have increased their use of these new platforms to interact with patients and doctors.  Mobile health (mHealth) apps are on the rise.  And with an estimated 3.4 billion smartphone or tablet users with access to mobile health apps by 2017 (according to Research2Guidance), this market represents an enormous opportunity for pharma.  The market will continue to increase as smartphone use spreads into developing countries and as baby boomers age, two groups that could particularly benefit from improved healthcare information and access. Continue reading

Promising Oncology Drug Receives Third Breakthrough Designation from FDA

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17. For those keeping score at home, this is ibrutinib’s third breakthrough therapy designation. In February 2013, the FDA granted breakthrough designations for ibrutinib’s use in relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). Continue reading

Pharma, Drug Safety and REMS (Oh My!): Risk Mitigation and Pharmaceutical Companies

Pharmaceutical companies may not take the Hippocratic Oath, but, through dedicated pharmacovigilance programs, companies ensure that drug safety remains a top priority among their medical affairs responsibilities.  Within companies’ medical affairs teams, evaluating drug safety begins with determining a drug’s projected benefits and measuring them against any associated risks.  Upon determining a favorable balance, dedicated cross-functional teams propose strategies to best address and navigate any foreseen risks.  Continue reading

Longer regulatory approval timelines? It’s not all FDA’s fault.

Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some countries. Many companies are adding substantial numbers of regulatory affairs personnel, preferably of the very experienced variety, to deal with the increased issues. Continue reading

The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma

By Casey Ferrell,
Senior Research Analyst

In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn’t always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals more wins.

In pharmaceutical regulatory affairs, the same is increasingly true. To the detriment of smaller players and the benefit of bigger ones, talented regulatory affairs personnel are in high demand; this seems to be driving rapidly growing salaries. Companies with deeper pockets are snatching up the best and brightest regulatory affairs professionals working, creating a talent gap in the industry, the ripple effects of which are numerous and consequential. Continue reading

Physician Payment Disclosures and FMV Going Strong Despite Sunshine Act Delays

By Elio Evangelista,
Director of Research

The United States is still waiting for the Centers for Medicare and Medicaid Services (CMS) to issue its final ruling on how it will implement the disclosure rules outlined in the Physician Payments Sunshine Act. However, this has not deterred companies from continuing to make public disclosures or caused them to lose focus on determining fair-market value (FMV) physician fee schedules.

Initially, CMS was scheduled to give a ruling to drug and device manufacturers in October 2011. But the agency Continue reading