Industry News

The United States faces a converging public health crisis as the nation’s opioid epidemic fuels growing rates of certain infectious diseases, including HIV/AIDS, hepatitis, heart infections, and skin and soft tissue infections. Infectious disease and substance use disorder professionals must work together to stem the mounting public health threat, according to a new commentary in the Journal of Infectious Diseases. The article was co-authored by officials from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore.

Acute flaccid myelitis (AFM) presents significant challenges not only to patients but also to researchers, and efforts must be accelerated to learn more about the condition, experts from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, write in a new perspective published in mBio.

WHO is urging governments to enforce bans on tobacco advertising, promotion and sponsorship at sporting events, including when hosting or receiving broadcasts of Formula 1 and MotoGP events.

U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples common devices used in many surgeries and to provide updated recommendations to help reduce risks associated with their use.

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus.

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisationin the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.

The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for the treatment of the familial chylomicronaemia syndrome (FCS).

U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.