Life Sciences and Healthcare

Med-techs extend borders seeking new opportunities

Medical device companies, eager to drive growth, are now increasingly seeking new opportunities – and approvals from regulators – throughout the world. Three recent examples of companies extending their reach across borders include: U.S.-based Abiomed garnering approval in India for three heart pumps; I. Ceram, a French company, achieving CE mark certification in Europe for […]

Shire’s Takhzyro expected to dominate in hereditary angioedema

The 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics,  anticipated the approval and market entry of Shire’s Takhzyro (lanadelumab).  The drug was approved in the U.S. under accelerated review, with Orphan Drug, Fast Track and Breakthrough Therapy status, as expected in August 2018, for the prevention of hereditary […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]

Understanding the HIV challenge in South Africa

The quest to reduce the HIV burden in Sub-Saharan Africa (SSA) involves a multi-faceted and multi-disciplinary approach. While detailed understanding of the pathogenesis, virology, immunology and epidemiology as it relates to HIV/AIDS is crucial, ways to curb the disease require constant attention and innovation, as do the socio-economic implications. Working in partnership is critical, given […]

FDA draft guidance addresses inclusion of adolescents in oncology trials

With an eye toward helping industry, investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials. Allowing adolescents in relevant trials would allow for earlier access to life-saving drugs in this […]

The contribution of Type 2 diabetes to the disease burden in South Africa

In South Africa, 1,826,100 cases of diabetes were reported in 2017, corresponding to a prevalence of 5.4%. Overall, numbers are reported to be increasing over time. Diabetes also ranked high among the top 10 leading natural causes of death, accounting for 5.4% of deaths (year 2015). Approximately 14% of ischemic heart disease, 10% of stroke, […]

It’s the end of the Medicare Shared Savings Program as we know it

The Centers for Medicare & Medicaid Services’ long-awaited proposed changes to the Medicare Shared Savings Program are designed to usher in a new phase of the program beginning in 2020. The changes would require that all MSSP accountable care organizations be held accountable for both the cost and quality of care. The biggest proposed change […]