News & Analysis as of

Life Sciences

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

USITC Responds to Trade Representative’s Request to Identify ‘Unforeseen Developments’ That Led to Solar Cell Decision

by Morgan Lewis on

US International Trade Commission’s response to unforeseen developments signals strong administration action on solar cell tariffs....more

PTAB Life Sciences Report - January 2018

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Micro Labs Ltd. v. Santen Pharmaceutical Co. - PTAB Petition: IPR2017-01434; filed May 12,...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

2017 Technology and Life Sciences IPO Report

Wilson Sonsini Goodrich & Rosati’s 2017 Technology and Life Sciences IPO Report sets forth data related to 61 U.S.-based technology and life sciences initial public offerings that priced between January 1 and December 15,...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery on

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim

by Morgan Lewis on

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act. Shortly after Amgen received US Food and Drug Administration (FDA)...more

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

by Hogan Lovells on

Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

Patent Owners’ Use of Unexpected Results Before IPR Institution

Patent owners in the life sciences and chemistry areas must frequently decide whether to submit evidence of unexpected results as part of their preliminary responses in inter partes review (IPR) or other post-grant...more

The Enneagram and the Practice of Law

by Zelle LLP on

You may have heard of the Enneagram in passing or at dinner parties, and growing interest may be considered by some to be a fad, or a parlor-game, similar to interpreting astrological signs, or business-focused personality...more

Healthcare & Life Sciences Private Equity Deal Tracker: NovaQuest Acquires Viamet Pharmaceuticals

by McGuireWoods LLP on

NovaQuest Capital Management has agreed to acquire Viamet Pharmaceuticals, according to a news release. Viamet, based in Durham, N.C., is a biopharmaceutical company focused on the discovery, development and...more

Top Stories of 2017: #10 to #14

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe...more

PTAB Life Sciences Report - December 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Visionsense Corp. v. Novadaq Technologies, Inc. PTAB Petition: IPR2017-01426; filed May 11,...more

California Supreme Court Recognizes “Innovator Liability”

Last week, the California Supreme Court in T.H. v. Novartis Pharmaceuticals Corp., became the first state high court to recognize the doctrine of “innovator liability,” unanimously holding that brand-name prescription drug...more

2017 Biosimilar Approvals in Europe

The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products –...more

Biotech M&A: What Happened in 2017 and the Year Ahead

by Locke Lord LLP on

Looking across the entire M&A spectrum, overall deal values were generally on the decline in 2017. PricewaterhouseCoopers reports that ‘‘M&A values decreased by over 60% in Q3 2017 as compared to Q2 2017, and the $30.0...more

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

by Goodwin on

The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

by McDermott Will & Emery on

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications

by Ropes & Gray LLP on

What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations? In this recap of our fourth quarter presentation, which...more

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

by Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

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