Biotechnology Healthcare

News & Analysis as of

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

Industry Reports on 3Q U.S. IPO Market Activity

Renaissance Capital released its Fall 2015 US IPO Preview in early September, which reported that 131 IPOs were completed, raising $22 billion. The healthcare sector led the IPO market in number of offerings thanks to the...more

Trans-Pacific Partnership May Have Far-Reaching Consequences for U.S. Industry

This week, the 12 Trans-Pacific Partnership (TPP) member countries decided the final terms of what they report is a far-reaching agreement (Agreement or TPP Agreement). The 12 TPP countries are Australia, Brunei Darussalam,...more

Precision Medicine - Even Medicare Will Pay for It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Crowdfunding and IP in Health and Biotech Start-ups (Part 2): The JOBS Act

Crowd Funding ImageThis is the second in a 3-part series about the use of crowdfunding in health and biotech start-ups. We started with the story of a tech start-up which set records for funding through a Kickstarter...more

Patent Profile: DermTech Receives Patent for Method of Detecting Melanoma in Human Subjects

The U.S. Patent and Trademark Office recently issued a notice of allowance for U.S. Application No. 14/199,900, which is entitled "Diagnosis of Solar Lentigo by Nucleic Acid Analysis." The '900 application, which is assigned...more

California Healthcare Institute Releases 2015 California Biomedical Industry Report

The California Healthcare Institute and PricewaterhouseCoopers, LLP have released their 2015 California Biomedical Industry Report describing industry trends through 2014. The CHI report highlights the continued strength of...more

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

North Carolina Legislative Report

The General Assembly’s Short Session began Wednesday, May 14, 2014. The MVA Public Affairs Legislative Report on North Carolina will be distributed weekly to keep you up to date on the latest legislative issues facing the...more

Organovo Forms Partnership with University of Queensland to Print Human Kidney Tissue Organovo Forms Partnership with University...

The government of Queensland, Australia recently announced a partnership between San Diego-based Organovo and UniQuest, the commercialization arm of the University of Queensland. According to Organovo’s website, the company...more

FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

Health Subcommittee Seeks Ideas on How Technology Can Improve Patient Care

Last Thursday, the House Energy and Commerce Subcommittee on Health held a hearing, “Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients,” to explore how technology can be harnessed to advance the...more

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

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