Life Sciences

News & Analysis as of

Healthcare & Life Sciences Private Equity Deal Tracker: Linden Capital Acquires ProPharma Group, Merical

Linden Capital Partners announced earlier this month that it acquired ProPharma Group and, in a separate transaction, acquired Merical. Linden, based in Chicago, seeks control equity in middle-market companies. A leading...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

Life Sciences Spotlight - Asia Pacific Issue 7, 2016

Welcome to the seventh edition of Life Sciences Spotlight, and our very first AusBiotech/Biofest conference edition. We are very pleased to provide updates on a number of developments in the life sciences sector across...more

Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers

Life sciences companies regularly review their labeling and promotional materials to ensure compliance with Food and Drug Administration requirements. FDA makes its Warning Letters publicly available, and failure to correct...more

Smart Regulations: The Oversight of Artificial Intelligence

The Obama administration's National Science and Technology Council released a report on artificial intelligence (AI) last week that shared findings on the current state of AI and its potential effect on society. The council...more

European Health Care Compliance Challenges (And Solutions)

Life sciences and health care companies (“health care companies”) rightly invest a significant amount of time and money into ensuring compliance with health care regulations in the countries in which they are based, but...more

Update on Life Sciences Exports to Iran and Sudan

On September 28, the Office of Foreign Assets Control (OFAC) at the U.S. Department of the Treasury issued its Biennial Report of Licensing Activities Pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000,...more

September 2016 IPO Market Review

The IPO market produced 14 IPOs in September, representing the second highest monthly figure for 2016 and only one behind May’s tally of 15 IPOs. The month’s total represents the third-busiest September since 2000, trailing...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

Second Quarter Venture Funding Increases 20% from First Quarter

Earlier this year, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VII, The Microbiology of the Built Environment

Many research efforts into the microbiome have focused primarily on the human microbiome, i.e., microorganisms within and on the body, and how changes in these microbial communities correlate with changes in health and...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

USPTO Announces 2016 Patents for Humanity Winners

On Thursday, the U.S. Patent and Trademark Office announced the latest winners of the Patents for Humanity program. The Patents for Humanity program, which was launched by the Office in February 2012 as part of an Obama...more

Donations and Grants in China: Compliance Controls Beyond T&E

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

PTAB Life Sciences Report - September 2016 #2

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Medtronic Xomed, Inc. v. Neurovision Medical Products, Inc. - PTAB Petition: ...more

Blog: Federal Court Gives Teeth to Operational Efforts Covenant in Sanofi/Genzyme Earn-Out Dispute

We keep a close eye on developing cases regarding earn-outs and contingent payment rights in light of the prevalent use of these arrangements in life sciences deals and their increasing use in non-life sciences deals. On...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)

The complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed...more

Healthcare & Life Sciences Private Equity Deal Tracker: Pharos Capital Acquires Controlling Stake in TechLab

Pharos Capital Group has announced it has acquired a controlling position in TechLab. Pharos is acquiring its stake from Alere and TechLab’s founders, who will remain with the company and maintain a minority investment....more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

Every U.S. Life Sciences Company Needs an Export Control Compliance Program (No, Really….)

Two recent settlements by the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) confirm that every U.S. life sciences company engaging in exports should have an effective U.S. export control compliance...more

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