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The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Data privacy in the Americas - At a glance

As multinational employers are aware, data privacy laws can vary greatly from jurisdiction to jurisdiction. Ensuring compliance with the different requirements can be challenging, and the penalties for noncompliance can be...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

DOD Adopts Interim Cyber Rules As Claims of Chinese Cyber Attacks Continue

U.S. officials have blamed Chinese government-backed attackers for many of the recent cyber attacks on U.S. government and business computer networks: “Researchers and government officials have determined that the Chinese...more

Summer is (Almost) Over & Congress is Back!

While summer isn’t officially over until September 22, for most here in the nation’s capital the vacations are nearly completed and it is back to work as Congress returns from the long August recess and Labor Day...more

The Telehealth Top 10 for 2015

Telehealth continues to be an innovative alternative to traditional brick-and-mortar medicine. The number of providers offering telehealth services is rapidly increasing and states are enacting laws requiring health plans to...more

Telemedicine or just a gadget for fitness addicts? Mobile Health Apps and the law

Mobile health (mHealth) apps are becoming more and more popular. Back in 2013, more than 97,000 health apps were already on the market. According to the European Commission (EC), this figure now amounts to around 100,000...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

EMBA Medical’s Hourglass™ Device Awarded CE Certificate

EMBA Medical Ltd., headquartered in Dublin, Ireland, recently announced that it has received CE certification for its Hourglass™ Peripheral Embolization Plug as a Class IIb medical device....more

China FDA Solicits Comments on Resolving the Backlog of Drug Applications

The China Food and Drug Administration (“CFDA”) recently published a draft circular to address the backlog of drug applications. The Circular Regarding Several Draft Policy Opinions to Accelerate the Resolution of the Backlog...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

China Removes Price Ceilings from Most Drugs

Chinese consumers have long complained about high drug prices. To address this problem, in 2000 the Chinese government adopted a price ceiling system for drugs. At that time, the medical insurance system and the drug bidding...more

Health Alert (Australia) - June 1, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Australia. Family Court - 22 May 2015 - Re Ashley [2015] FamCA 37 The Family Court has found that a 17 year old...more

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