Life Sciences

News & Analysis as of

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

TransEnterix Acquires ALF-X for $99.8 Million

Research Triangle Park, North Carolina-based TransEnterix, Inc. announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company. According to the announcement, the deal is a...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

Cantel Acquires Medical Innovations for $79.5 Million

Cantel Medical Corp. has acquired medical device business Medical Innovations Group Holdings Ltd. for $79.5 million, according to press releases. According to its website, Cantel Medical is a global company dedicated to...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

Back to school – the last year in patents: September 2015

The vexed question of how to enforce second medical use patents has dominated the headlines in the last half year. The case of Warner-Lambert v Actavis1 in the English High Court highlighted the serious difficulties...more

Compensation to Human Clinical Study Participants: A (Very) Informal Survey

At least once a month, life science clients reach out to us to ask us about best practices on a particular topic or to benchmark a proposed activity against what others in the industry might be doing. One such request,...more

HeartWare International To Acquire Valtech Cardio

HeartWare International recently announced that it has entered into a definitive agreement to acquire Valtech Cardio, Ltd. Yehuda, Israe-based Valtech Cardio currently provides a transcatheter mitral valve repair product for...more

Greatbatch, Inc. Completes $1.73 Billion Acquisition

Greatbatch, Inc. recently announced that it has acquired Lake Region Medical (previously known as Accellent Inc.) pursuant to a deal valued at about $1.73 billion.  Reuters reports that Greatbatch will pay $478 million in...more

Blog: BEWARE: DOJ Announces New Policy to Increase Prosecutions of Individuals Involved in Corporate Fraud

Earlier this week, Deputy Attorney General (AG) Sally Quillian Yates issued a memorandum to Department of Justice (DOJ) attorneys discussing the need to hold individuals accountable for corporate wrongdoing in both civil and...more

Edwards Completes Acquisition of CardiAQ

According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Healthcare & Life Sciences Private Equity Deal Tracker: Intellia Therapeutics Secures $70 Million in Financing

Intellia, based in Cambridge, Mass., is gene editing company focused on the development of curative medicines utilizing a developed biological tool known as the CRISPR/Cas9 system....more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Claims Are Construed After Interference Proceedings

The court first determines that when a party is challenging a claim’s compliance with the written description requirement during an interference, the originating disclosure provides the meaning of the pertinent claim...more

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

Long-Awaited Notice of Proposed Rulemaking for Federal Policy for the Protection of Human Subjects Released

On September 2, 2015, the Department of Health and Human Services released the long-awaited Notice of Proposed Rulemaking seeking comment on proposed revisions to the Common Rule, aimed at modernizing, strengthening, and...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Octopus Genome Sequenced

Invertebrate zoology is in many ways the most comprehensive survey course on biology, encompassing most multicellular life on the planet. (Indeed, the study of the Order Coleoptera alone, comprising the beetles, would...more

Intellectual Property and Technology News - Issue 27 Q3 2015

In This Issue: How Private is That Connected Car? US v EU Among the fastest growing sectors in the industry of smart things is the connected car. No longer a simple way from point A to point B, cars now comprise a...more

Generating Life Sciences Brand Names: 5 Key Tips

In the challenging and complex world of life sciences product development, choosing a brand that survives the US Patent and Trademark Office and US Food and Drug Administration clearance processes is critical. Brand names in...more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

Healthcare & Life Sciences Private Equity Deal Tracker: Wave Life Sciences Secures $66 Million in Financing

WAVE Life Sciences, based in Boston, is a genetic medicine company focused on developing stereopure nucleic acid therapies for patients impacted by rare diseases....more

Healthcare & Life Sciences Private Equity Deal Tracker: Metacrine Secures $36 Million in Financing

Metacrine, based in San Diego, Calif., is a biotechnology company focused on advancing research in nuclear hormone receptors for treatment of metabolic diseases originated at the Salk Institute for Biological Studies....more

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