News & Analysis as of

Life Sciences › Pharmaceutical Industry › License Applications

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

American Conference Institute (ACI) on

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Proskauer - The Patent Playbook

BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

Proskauer - The Patent Playbook on

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA Accepts Bio-Thera’s BLA for Bevacizumab Biosimilar

Rothwell, Figg, Ernst & Manbeck, P.C. on

On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA Accepts Review of Samsung Bioepis and Biogen’s Ranibizumab Biosimilar

Rothwell, Figg, Ernst & Manbeck, P.C. on

On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed...more

MoFo Life Sciences

Pediatric Exclusivity For Biologics

MoFo Life Sciences on

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy...more

Fish & Richardson

How Biosimilars Are Approved and Litigated: Patent Dance Timeline

Fish & Richardson on

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Foley & Lardner LLP

Industry Perspectives On The Biosimilar Patent Dance

Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

8 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide