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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Japan Regulators Kept On Track Despite Pandemic

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

Japan Regulation

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Review Pathway Post Market Regulation & Studies

Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

Approvals Review Pathway

Hanmi And LG Chem Highlight Vaccine Prowess, Novel R&D At JPM

Hanmi showcases at JPM its contract production capabilities for COVID-19 vaccines as South Korea prepares to bring in candidates from several global developers, while LG Chem highlights progress across multiple pipeline projects.

South Korea Research and Development Strategies
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Company Information

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  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
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