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Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

Health Alert (Australia) - December 22, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 19 December 2014 – Dr Reid v Medical Council of NSW - [2014] NSWCATOD 152 - The Medical Council...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Realizing the Potential of Telemedicine in China, Part 2: Data Privacy and Security

The Chinese market presents a tremendous opportunity for U.S. hospitals and providers, as long as the intricacies of data privacy and security issues are thoroughly understood. This includes Chinese regulations regarding...more

25 Ways Manufacturers Can Drive Profitability

Cohen & Company recently hosted “25 Way to Drive Profitability,” a workshop in Youngstown geared specifically toward manufacturers. Beginning with an overview by Rick Schiraldi of the Valley’s manufacturing roots and history,...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Health Alert (Australia) - November 3, 2014

In This Alert: Judgments; Legislation; and Reports. Excerpt from Legislation: Dental Benefits Legislation Amendment Bill 2014 passed both house 30 October 2014 Amends the Dental Benefits Act 2008 and...more

Africa Update - October 2014 #5

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

China to Open Up Its Hospital Market to Foreign Investment on a Pilot Program

On August 27, 2014, the National Health and Family Planning Commission (“NHFPC”) and Ministry of Commerce (“MOFCOM”) jointly released Notice on Conducting Pilot Work of Setting Up Wholly Foreign Owned Hospitals) (“Notice”)...more

Health Alert (Australia) - October 27, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 23 October 2014 - Vision Eye Institute Ltd v Kitchen & Anor [2014] QSC 260 In 2006, Kitchen sold...more

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Africa Update - October 2014 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from Leading the...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

Lame Duck Preview

With the November elections looming, the House and Senate completed their work last week before departing Washington to campaign, leaving any remaining legislative work for the post-election lame duck session. The brief work...more

Privacy Tuesday – September 2014

Happy autumnal equinox Home Depot Breach – By the Numbers: - 56 million cards at risk (compare to Target = 40 million) - $62 million in estimated costs (compare to Target =$146 million and...more

China Issues New Telemedicine Opinions for China and Foreign-Based Providers

Telemedicine providers and vendors doing business in China, whether based in China, the United States, or elsewhere, received new guidance on the use of telemedicine in China....more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services

In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were...more

Health Alert (Australia) - August 18, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 25 July 2014 (published 8 August 2014) - Cotterell v Redcliffe Assembly [2014] QCAT 357 - The...more

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

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