News & Analysis as of

Best Practices For Laser-Assisted Cataract Surgery

A femtosecond (FS) laser is exciting new technology, but it requires consideration of some important governance and compliance issues. Best practices require the surgeon and the facility (ASC or Hospital) to identify covered...more

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

CMS Posts ICD Technology Assessment

CMS has posted a new technology assessment for implantable cardioverter-defibrillators (ICDs) addressing the evidence for use of ICDs for “primary prevention” of sudden cardiac death (SCD)—prevention of SCD in patients who...more

From Personal Computers to Personalized Medicine

Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry....more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

China Life Sciences Health Industry Client Briefing – May/June 2013 (July 12, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - .. Medical Devices Regulations and News - Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more

Court Report -- June 30, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more

SCOTUS: Human Genes Cannot Be Patented. Is This the End or Beginning of Genetic Research?

For a Legal Perspective on today's much-anticipated U.S. Supreme Court "Myriad" decision that naturally occuring substances are not patentable, we turned to IP attorneys writing on JD Supra...more

Federal Court Rules That Issuers Face Strict Liability for Erroneous Statements About Legal Compliance in Registration Statements,...

A recent federal appeals court decision addressing pleading standards for shareholder suits under Section 11 of the Securities Act of 1933, as amended, highlights the potential dangers of giving broad assurances of legal...more

Sharing an Umbrella

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

Bilski v. Kappos: Effects on Biotechnology Patents

Although long-anticipated, the Supreme Court's opinion in Bilski did not provide much in terms of “pellucid” teachings regarding the metes and bounds of patent-eligible subject matter. Against this backdrop, the Court decided...more

Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries

Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more

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