December 2019

Gilead Sciences, Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in 2013. Although compounded drugs can fill an important role for patients and the FDA recognizes the need to preserve access to these products, they may also present a greater risk to patients because, among other things, they are not required to undergo the agency’s premarket review for safety, effectiveness and quality. These risks have become evident during inspections of outsourcing facilities when the agency has found concerning production practices that have resulted in recalls of compounded drug products and enforcement action against some firms.

World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.

The number of cholera cases decreased globally by 60% in 2018, the World Health Organization (WHO) announced in a report that points to an encouraging trend in cholera prevention and control in the world’s major cholera hotspots, including Haiti, Somalia and the Democratic Republic of the Congo.

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme.

In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. NASEM was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence where future research is needed. We greatly appreciate all the work done by NASEM to produce the consensus reportExternal Link Disclaimer released.