International Law & Trade, Health Law, Science, Computers & Technology

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

US Sues Novartis for Alleged Pharmacy Kickback Scheme

by Josh Crank | Lawyers.com on 4/30/2013

Swiss drug maker Novartis has been sued by a U.S. Attorney for allegedly paying kickbacks to pharmacies that converted thousands of patients to one of its drugs. The civil fraud suit accuses the company of disguising the...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 4/29/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

China Clarifies Fast Track Approval Eligibility for Novel Biologics

by Katherine Wang | Ropes & Gray LLP on 3/13/2013

The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1)...more

China Life Sciences Health Industry Client Briefing – February 2013 (March 11, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 3/12/2013

In This Issue: New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced (China Securities Journal 2013-02-20) – February 20, 2013; China to Encourage Innovative Drug Development (Xinhua News Agency...more

News from Abroad: Bill to Diminish Term of Patents for Medicaments

by McDonnell Boehnen Hulbert & Berghoff LLP on 3/6/2013

Originally published in Olivares & Cia. on March 4, 2013. In January, the Mexican Senate published a Bill adding article 23 bis to the Industrial Property Law (IP Law). This Bill intends to establish a "special" life...more

China Life Sciences Health Industry Client Briefing – January 2013 (February 21, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 2/22/2013

In This Issue: Li Keqiang Comments from the 12th Plenary Meeting of the Medical Reform Leading Group (USCBC 2012-01-06) – January 6, 2013; MOH Announces Roadmap for Medical Reform (USCBC 2012-01-10) – January 10, 2013;...more

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

by Bill Devinney | BakerHostetler on 2/7/2013

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

January 2013: European Litigation Update

by Quinn Emanuel Urquhart & Sullivan, LLP on 2/6/2013

The European Court of Justice (ECJ) on European Supplementary Protection Certificate (SPC) for Further Medical Uses: With a remarkable ruling from July 2012 (Neurim Pharmaceuticals, C-130/11), the European Court of Justice...more

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

by Brian P. Dunphy, Kimberly J. Gold, Karen S. Lovitch, Kate Stewart | Mintz Levin - Health Law on 2/5/2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

by Katherine Wang | Ropes & Gray LLP on 2/5/2013

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

China Trade Marks – Inclusion of Retail and Wholesale services relating to medicines and pharmaceuticals

by Jonathan Feder, Shalini Jayaweera, Anthony Watson | K&L Gates LLP on 1/21/2013

The China Trade Marks Office (CTMO) recently announced that from 1 January 2013 it is accepting applications to register trade marks in relation to retail or wholesale services for pharmaceutical, veterinary and sanitary...more

Spread of Laboratory-generated Antibiotic Drug Resistance in Chinese Rivers

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 12/28/2012

A generation ago, Jeremy Rifkin famously convinced the Cambridge city council to ban genetic engineering in that city, using the fear of "tinkering" with nature and producing a "superbug" that would hurt the public health and...more

EC Introduces Major Changes to Medical Device Regulation

by Jana Grieb, Kristian Werling | McDermott Will & Emery on 12/19/2012

The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics. The proposed legislation will significantly broaden the scope of medical device...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

China Life Sciences and Health Industry Client Briefing – October 2012 (November 16, 2012)

by Reed Smith on 11/20/2012

In This Issue: - China Becoming Healthcare R&D Hub (China Daily 2012-10-09) – October 9, 2012 - Imported Drugs to Go on China's Electronic Monitoring Network (Xinhua News Agency 2012-10-08) – October 9, 2012...more

China Issues Human Genetic Resources Management Regulations

by Foley & Lardner LLP on 11/19/2012

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more

Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs

by Katherine Wang | Ropes & Gray LLP on 11/15/2012

The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for...more

Physicians and Pharmacies Must Be Aware of the Dangers and Potential Penalties Associated with Importing Prescription Drugs

by Fuerst Ittleman David & Joseph, PL on 10/11/2012

Introduction - As the price of healthcare continues to increase, healthcare practitioners have become more innovative and creative in their attempts to keep costs affordable for their patients. One technique which has...more

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