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Latest From Celsion Corporation

‘Dangling’ Accelerated Approval Reviews Expand At US FDA

The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.

Advisory Committees Cancer

Endo Offloads Manufacturing Site To Strides Pharma

Endo enters into an agreement with the subsidiaries of Strides Pharma to sell its manufacturing site in Chestnut Ridge, New York. Meanwhile, the company sees a double-digit drop in its generics business. Furthermore, Endo executes settlement resolving all opioid-related claims in Tennessee.

Deals Generic Drugs

FDA Looks To Solve Chantix Shortage With Par ANDA Approval

Endo’s Par looks set to provide much needed supply in the US market for varenicline tablets, after originator Pfizer ran into supply and distribution problems due to the presence of a nitrosamine for its Chantix original.

Approvals Generic Drugs

Generic ‘Skinny Labels’ Get Reprieve As Court Agrees To Rehear Teva/GSK Case

Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.

Intellectual Property Legal Issues
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Egen, Inc.
    • Expression Genetics
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