FDA Commissioner Scott Gottlieb is addressing the impact to Puerto Rico's pharmaceutical manufacturing base following the damage from Hurricane Maria and has formed a hurricane task force. Read More

The US House of Representatives’ Energy and Commerce Committee is seeking information on a June 2017 cyberattack on Merck & Co. and the federal policies, plans, and procedures to deal with potential drug shortages and supply issues in the event of cyberattacks . Read More

Sanofi and Lonza have started constructing a large-scale biologics production facility in Visp, Switzerland. The companies formed a joint venture in February 2017 to build and operate a large-scale mammalian cell-culture facility for monoclonal antibody production. Read More

Fresenius Kabi has started a $250-million expansion of its pharmaceutical operations in Melrose Park, Illinois. The company is a provider in the US of generic sterile injectable medicines. Read More

Johnson & Johnson’s Janssen Biotech has received a Complete Response Letter (CRL) from the FDA requesting additional clinical data on safety for its biologics license application for sirukumab, a drug to treat rheumatoid arthritis. This is part of  DCAT Value Chain Insights  Pipeline News. Read More

Avara Pharmaceutical Services, a CDMO, has agreed to acquire GlaxoSmithKline’s 250,000-square-foot consumer healthcare manufacturing facility in Aiken, South Carolina. Read More

In two separate moves, Amgen has resolved intellectual property-related litigation with AbbVie for its proposed biosimilar to AbbVie’s top-selling cancer drug, Humira (adalimumab), and also has formed a biosimilar agreement in China. Read More

The FDA has selected nine companies to participate in a pilot program for digital health regulation in the US. Participating companies include Apple, Roche, J&J, Fitbit, and Google’s Verily. Read More

The European Medicines Agency, now headquartered in London, has outlined potential staffing issues with a re-location to another European Union member state in the wake of the UK exiting the EU. Read More

The FDA issued draft guidance to specify information needed for a proposed biosimilar with respect to the structural/physicochemical and functional attributes of the reference product, the analytical similarity assessment plan, and the statistical approaches for evaluating analytical similarity. Read More