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Pharmaceutical Industry › Food and Drug Administration (FDA) › Joint Venture

Goodwin

Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

Goodwin on

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo. Susvimo is a refillable ocular implant - requiring refills every six months - that continuously delivers...more

Goodwin

FDA Approves NDA for Semglee (insulin glargine injection)

Goodwin on

Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid...more

Goodwin

Biosimilar Developers Comment on Regulatory Delays

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Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. ...more

McDermott Will & Emery

IRS Office of Chief Counsel Treated Collaboration Arrangement as Partnership

McDermott Will & Emery on

In a newly released Chief Counsel Advice, the Internal Revenue Service (IRS) Office of Chief Counsel treated a collaboration arrangement relating to the development and commercialization of a drug as a deemed partnership for...more

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