Regulatory Oversight and Compliance

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.

FDA announced a public workshop to explore strategies for addressing the crisis of opioid addiction through innovations in packaging, storage, and disposal.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.

The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.

The agency has published educational material for physicians promoting the benefits of biosimilars.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The agency has published a continuity plan for its move from the United Kingdom.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

Europe updates the guideline on excipients information in labeling and packaging.

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

FDA published guidance on the format and content of REMS documents.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.