Pharmaceutical Industry China

News & Analysis as of

Your daily dose of financial news - The Brief – 8.23.16

The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....more

Business Litigation Report - July 2016

Article: Increase in Vertical Price Restraint Enforcement in China - In recent months, Chinese anti-monopoly enforcement actions scrutinizing and penalizing pricing-related issues have noticeably increased. A growing...more

CFDA Solicits Comments on Drug Registration Rules

The China Food and Drug Administration (“CFDA”) recently published long-awaited and comprehensive revisions (“Revisions”) to the Drug Registration Rules (“DRR”). The Revisions are now open to public comments until August 26,...more

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

China FDA Solicits Comments on Priority Review Designation Procedure for Devices

The China Food and Drug Administration (“CFDA”) recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority...more

Your daily dose of financial news - The Brief – 6.16.16

As expected, the Fed announced yesterday that it was holding current interest rates steady and would be slow to push rates up while the economy tiptoes toward stability. Much more from Chair Yellen and economists’ reaction...more

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Ken Adam and the Imagination of Reality – Corporate Governance

Ken Adam died earlier this month. If you are anything close to a James Bond aficionado, his name is well known to you for his creation of the fabulous sets on all the movies from Dr. No to Moonraker. I still marvel at the...more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

China FDA Launches a New Classification System for Registration of Chemical Drugs

China FDA formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs (“Reform Scheme”) on March 4, 2016. The Reform...more

Drug and Medical Device Corruption Risks in China

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

China’s Allopurinol Case: Double Jeopardy For One Anti-Competitive Scheme?

Two successive decisions from the SAIC and the NDRC, the Chinese antitrust agencies in charge of prosecuting cartels and abuses of dominance, in the same matter concerning allopurinol, a commonly used generic pharmaceutical...more

Your daily dose of financial news The Brief – 2.23.16

It’s a whole new ballgame for Wall Street traders—and one suspects it’s involving a lot fewer actual ballgames and a lot more algorithms, as the advanced-degree coders and their ETF firms take on the old guard – NYTimes...more

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Blood on the Tracks Hits No. 1 and the Lessons Learned from SciClone

On this week in 1975, Bob Dylan’s 15th studio album, Blood on the Tracks, reached the Number 1 album slot on the Billboard charts. This was in spite of no song rising above the 31st slot on the single charts. It came out in...more

SciClone Pharmaceuticals: A Textbook Case of FCPA Violations for Gifts, Meals, Entertainment and Travel

The Securities and Exchange Commission continues its steady march as the prominent FCPA enforcement agency against corporations.  The Justice Department has not brought any enforcement actions this year and continues to...more

Record breaker: US M&A in 2015

As the dust settles from the explosion of US M&A activity in 2015, it is fitting to reflect on the forces that fueled the boom and consider what last year’s trends may tell us about the year ahead. The record year...more

Alert: Top 10 Antitrust Developments and Trends to Watch in 2016

Attention in the US during 2016 will be on the presidential campaign, and the election in November will bring a change in the "antitrust guard" at the top of the DOJ and FTC – even if a Democrat wins – that will drive the...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

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