News & Analysis as of

Life Sciences Pharmaceutical Industry

Excessive pricing in pharmaceutical products attracts the European Commission's attention

by Hogan Lovells on

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...more

PTAB Life Sciences Report -- Part II - May 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd. PTAB Petition: IPR2017-01053; filed...more

PTAB Life Sciences Report - May 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd. PTAB Petition: IPR2017-01034; filed...more

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

by Jones Day on

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

PTAB Life Sciences Report - May 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pain Point Medical Systems, Inc. v. Blephex LLC - PTAB Petition: IPR2016-01670; filed August...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Relocation of the EU Medicines Agency – Germany

by Hogan Lovells on

"EMA" and "gErMAny" – far more in common than mere letters - The European Medicines Agency (the "EMA"/"Agency") has reached celebrity-style status in the aftermath of the Brexit vote, and is being wooed by most European...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. InnoPharma Licensing, LLC v AstraZeneca AB - PTAB Petition: IPR2017-00900; filed February 17,...more

California Federal Court Allows Indirect Purchasers of Securities to Sue Issuers for Fraud Under California Statute

by Carlton Fields on

A federal magistrate judge in California has allowed a securities fraud suit against a late-stage private company to proceed despite the plaintiff investors holding a security interest only through intermediary,...more

Relocation of the EU Medicines Agency – Ireland Island of Saints and Scholars

by Hogan Lovells on

The EMA is looking for a new home. In this blog post partner Elisabethann Wright argues the case for Ireland. For thousands of years Ireland has been known as the Island of Saints and Scholars. The country is also world...more

Securities Litigation Alert: District Court Says Indirect Purchasers of Shares Can Bring Fraud Claims Against Private Company and...

by Fenwick & West LLP on

In a case with important implications for late-stage private companies, a federal magistrate judge ruled last week that investors in funds holding private company securities can bring fraud claims against the issuer of the...more

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Smith & Nephew, Inc. v. ConforMIS, Inc. PTAB Petition: IPR2017-00778; filed January 26,...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

PTAB Life Sciences Report -- Part II - April 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Teva Pharmaceuticals USA, Inc. v. Allergan, Inc. - PTAB Petition: IPR2017-00576; filed...more

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Europe: Combatting illegal pharma trade

by Hogan Lovells on

We are delighted to announce the launch of our Combatting illegal pharma trade enforcement guide. This publication is a pharmaceutical industry-specific brochure which complements our suite of brand and trademark protection...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

2016 – a year at a glance

by FPA Patent Attorneys on

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...more

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