Hurricane's Impact of Pharma Manufacturing Leads Top Industry News

September 29, 2017

This week's sponsor:

1. FDA Addresses Pharma Mfg in Puerto Rico in Wake of Hurricane Damage

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

2. Congress Seeks Information on Pharma Cyberattack

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

3. Lonza, Sanofi Begin Construction of Biomanufacturing Facility

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

4. Fresenius Kabi To Invest $250 Million To Expand Sterile Mfg

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

5. Janssen Receives CRL from FDA for Arthritis Drug

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

6. GSK Sells Consumer Healthcare Plant

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

7. Amgen Settles Biosimilar Dispute With AbbVie; Enters Biosimilars Pact in China

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

8. FDA Selects Apple, Roche, J&J and Others for Digital Health Pilot

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

9. EMA Warns of Staffing Issues with HQ Change Post Brexit

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

10. FDA Issues Biosimilars Draft Guidance

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

Top Industry News is published and distributed by the Drug, Chemical & Associated Technologies Association (DCAT). The DCAT organization recognizes its members have minimal time to keep up with the continuous flow of news covering this dynamic industry. To help ensure our members never miss the most important stories impacting the global pharmaceutical manufacturing industry, we will deliver each Friday, the week's Top Industry News, as selected by DCAT Editorial Director Patricia Van Arnum. For more information, visit www.dcat.org .