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Pharmaceutical Industry › Fast Track Process

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO News Briefs

McDonnell Boehnen Hulbert & Berghoff LLP on

In a notice published earlier this summer in the Federal Register (85 Fed. Reg. 41570), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program. ...more

Robins Kaplan LLP

Financial Daily Dose 6.11.2019 | Top Story: Opioid Maker Insys Files for Chapter 11 Protection

Robins Kaplan LLP on

Opioid manufacturer Insys Therapeutics, which just last week agreed to pay $225 million to “settle a federal investigation into the marketing practices for its powerful fentanyl painkiller,” has filed for bankruptcy...more

Knobbe Martens

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

Knobbe Martens on

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

Knobbe Martens

FDA Approves Zelboraf for Treatment of a Rare Cancer

Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Global Patent Prosecution Newsletter - November 2017

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues - We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more

Hogan Lovells

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

Hogan Lovells on

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

Knobbe Martens

Bayer Receives Accelerated Approval for Aliqopa

Knobbe Martens on

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

Foley & Lardner LLP

Pacific Rim Countries Reach Historic Agreement on the Trans-Pacific Partnership, But Will Congress Approve It?

Foley & Lardner LLP on

Trade ministers from 12 Pacific Rim countries announced, on October 5, 2015, that they had reached an agreement in principle on the Trans-Pacific Partnership (TPP). The TPP would arguably be the largest free trade agreement...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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