Licenses, Pharmaceutical | JD Supra Law News

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 3/7/2013

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

by Katherine Wang | Ropes & Gray LLP on 3/4/2013

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

China Life Sciences - January 2013

by Gabriel Bloch, Peng Chen, Gordon Milner, Kun Wang | Morrison & Foerster LLP on 1/17/2013

In This Issue: Investor Q&A; Key Regulatory Issues for Strategic Life Sciences Partnerships in China; Compulsory Patent Licensing in China; and New Developments on the “Patentable Subject Matter” Requirement of U.S....more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

Doing Business in Canada: Technology

by Bennett Jones LLP on 10/18/2012

Many Canadian businesses are involved in researching and developing cutting-edge technology in a number of areas including: information technology, high-tech, life sciences, pharmaceuticals, clean technology, environmental...more

FTC Sights Set on Pharma Deals – Calls for Additional Hart-Scott-Rodino Reporting

by Proskauer Rose LLP on 8/29/2012

The Federal Trade Commission has proposed expanding Hart-Scott-Rodino reporting and waiting period obligations for certain pharmaceutical, biologics and medicine manufacturing licenses. The new rules are subject to public...more

Yet Another Turn of the Screw: The FTC Again Targets Pharmaceutical Industry, This Time Through the HSR Act

by K&L Gates LLP on 8/21/2012

Fresh from its victory in the Third Circuit on “pay-for-delay” deals involving brand name and generic pharmaceutical companies, the Federal Trade Commission (“FTC”) has announced yet another initiative aimed at the...more

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Licenses › Pharmaceutical