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

Potential Product May Ring True for Hearing-Loss and Tinnitus Patients

By Sarah Ray,
Research Analyst

When some people hear a ringing in their ears, perhaps they think someone is talking about them.  Or, in an office environment, they may equate the noise to the steady hum of fluorescent lights.  For many, this scenario is a fleeting inconvenience.  But for others, this ringing, or tinnitus, is an ongoing concern.  Depending on its severity, tinnitus — often a byproduct of a larger ailment — can be debilitating. Continue reading

Advisory Board Functions Expanding in Pharma Industry

By Jacob Presson,
Research Analyst

Advisory boards have been part of the pharmaceutical landscape for a long time, providing companies with valuable expert opinions on topics ranging from ensuring thorough regulatory submissions to clinical trial protocols.  This role does not look to fade anytime soon, as regulatory requirements get tougher and payers look for ever more clinical data and health outcomes to prove the value of products on the market.  Many companies are working to create a cohesive advisory board strategy that encompasses which groups are best suited to handle the responsibility of coordinating advisory boards and how to achieve a useful deliverable out of a board meeting. Continue reading

Advaxis’ Cervical Cancer Treatment Comes to ASCO

The American Society of Clinical Oncology’s (ASCO) annual meeting is fast approaching, scheduled for May 31st to June 4th in breezy Chicago.  One of the many to present data this year is Advaxis, a biotechnology company that develops cancer and infectious disease immunotherapies.  The company’s keystone product, ADXS-HPV, is based on technology developed at the University of Pennsylvania and is currently being tested in five clinical trials.  The product targets HPV-related diseases, including cervical, head and neck and anal cancer.  The company will give presentations on two Phase II trials of the drug next month: one in the treatment of recurrent/refractory cervical cancer in Indian women and the other in the treatment of persistent or recurrent cervical cancer. Continue reading

New Clinical Trials Offer Promise for Melanoma Treatments

Melanoma is the deadliest form of skin cancer.  Although the World Health Organization estimates that melanoma accounts for only 5% of skin cancer cases — or 132,000 annual cases globally — it accounts for 75% of skin cancer deaths.  However, compared with other cancer types, melanoma remains a small area of study. shows that, over the past 10 years, excluding studies of unknown status, there have been approximately 1,070 melanoma clinical trials.  According to Biopharm Insight, 15 approved drugs exist to treat melanoma, with another 49 active drug programs in Phase 3. 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

Product Development Stage Dictates Medical Affairs Spending Patterns

Although marketing and market access functions may not support a developing drug until Phase 2 or even later, companies need to coordinate between several different teams as products move through different development stages beginning in the pre-clinical stage. Understanding the science behind the product is increasingly important for market access functions as payers increasingly require comparative effectiveness research and health outcomes data. 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