News & Analysis as of

Life Sciences

Seattle Genetics Acquires Cascadian Therapeutics, Continuing a Strong 2018 Start in Biotech Mergers and Acquisitions

by Knobbe Martens on

On January 31, two Seattle biotech companies, Seattle Genetics and Cascadian Therapeutics, announced a merger agreement under which Seattle Genetics will acquire Cascadian Therapeutics for $614 million. The announcement...more

What’s trending: The factors that can trigger supply chain disruption and litigation in the life sciences industry

by Hogan Lovells on

Change is coming to the life sciences industry. Price pressure, new market entrants, the emergence of personalized medicine, and even climate change are adding complexity to traditional manufacturing processes and supply...more

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Practical GDPR Steps for US-Headquartered Life Sciences Companies

In case you had not heard, the European Union is replacing its current privacy laws with a new, comprehensive General Data Protection Regulation (GDPR), which takes effect May 25, 2018. The essential principles of the EU’s...more

Dechert survey: Developments in securities fraud class actions against U.S. life sciences companies

by Dechert LLP on

2017 was a record year for class action securities litigation, and life sciences companies continued to be popular targets of such lawsuits. During 2017, plaintiffs filed a total of 88 class action securities lawsuits against...more

Government data mining leads to more aggressive investigations

by Hogan Lovells on

The government is leveraging its access to big data in order to aggressively pursue healthcare investigations. Maria Durant and Gejaa Gobena, partners in our Boston and Washington, D.C. offices, discuss the steps life...more

Technology and Life Sciences IPO Survey – 2017, Full Year

by Fenwick & West LLP on

This report analyzes key aspects of initial public offerings (IPOs) for technology and life sciences companies that went public in 2017, with emphasis on data from the second half of the year. Our IPO Survey was developed for...more

Blog: The Cooley Outlook for 2018 M&A

by Cooley LLP on

What’s on tap for 2018 M&A? A recap of 2017 trends and the Cooley outlook on this year’s dealmaking: - Buying Innovation: Retention and Non-Competes. For both old-line companies and tech giants, innovation is the name of...more

JPM Conference Takeaways: Biotech and Biopharma Set for Growth in 2018

Coming off a year that saw a record number of new drug approvals, significant scientific breakthroughs and a year-end tax reform package that both significantly lowers corporate taxes and provides the long-awaited tax...more

January 2018: Federal Circuit Issues Important Decision On Written Description And Enablement In Amgen Inc. v. Sanof

In Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), the Federal Circuit acknowledged the relevance of post-priority date evidence in determining whether claims satisfy the written description and enablement requirements,...more

New Jersey Regulation Caps Payments to Health Care Providers by Pharma Manufacturers

by Reed Smith on

On January 16, 2018, New Jersey enacted a new regulation which regulates the payments and items of value that prescribers can accept from pharmaceutical manufacturers. The regulation limits acceptance by prescribers of such...more

PTAB Life Sciences Report - February 2018

About the PTAB Life Sciences Report: periodically, we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH - PTAB Petition: ...more

FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders

by Morgan Lewis on

The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and announced a public meeting on enrollment criteria, signaling the agency’s...more

Hogan Lovells Moscow Life Sciences team secures major win in a precedent patent case for Novartis against a generic producer in...

by Hogan Lovells on

Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more

A Framework for Readying Your Institution for Complying With the Revised Common Rule

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19,...more

PTAB Life Sciences Report - January 2018 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Acclarent, Inc. v. Ford Albritton, IV - PTAB Petition: IPR2018-00268; filed December 1, 2017....more

A road map to successful Life Sciences transactions in Europe

by Hogan Lovells on

In this road map, members of our European Life Sciences Transactions Team provide country-specific perspective and guidance to help you navigate the jurisdictional challenges and differences that you may run into when...more

Securities Class Action Filings Reach Record High

As expected, securities class action filings reached a high-water mark in 2017. In fact, last year’s total of 400-plus filings was the second-highest on record, topped only by 2001, when the number was skewed by more than 300...more

In Case You Missed It: Launch Links - January, 2018 #2

by WilmerHale on

Some interesting links we found across the web this week: 5 New Venture Deliverables Put You Ahead of the Crowd - Building a thorough business plan helps many founders articulate and express their ideas to investors....more

Moratorium on Medical Device Excise Tax Extended for Two Years

by Morgan Lewis on

With the passage on January 22 of continuing appropriations through February 8 (HR 195), the moratorium on the medical device excise tax has been further extended until January 1, 2020, providing relief to medical device...more

A data-driven era: Why digital tools are critical to life sciences players

by Hogan Lovells on

Dr. Jörg Schickert discusses the critical role digital health tools will play in the future of life sciences....more

The CRISPR Chronicles -- Broad Institute Wins One and Loses One

The interference between the Broad Institute and the University of California/Berkeley has been in the spotlight over the past year. But there have been other skirmishes between the parties, each of which has recently been...more

Novel Theories Emerge in Merger Enforcement

Antitrust merger enforcement historically has focused on horizontal mergers — consolidation of two firms that compete directly in the same space. This is especially true in the U.S., where antitrust authorities have...more

What Pharma Companies Need to Know about FDA’s New Draft IVD Guidance

by Morgan Lewis on

As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more

2018 outlook for drugs and medical devices in China: regulatory reform fueled by innovation

by DLA Piper on

The year 2017 ended with a central government directive to reform the regulatory approval system for drugs and medical devices and a subsequent flood of CFDA changes and proposed changes to the system, and we should see...more

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