News & Analysis as of

Biopharmaceutical

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage...more

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

by Knobbe Martens on

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

Considerations for Developing a Global Patent Term Extension Strategy

Many jurisdictions provide for the extension of the term of the patents that cover a regulated product. Patent term extension (PTE) is particularly important in the bio/pharma industry given that development of an innovative...more

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

Global Patent Prosecution Newsletter - August 2017

Worldwide Patent Term Extension Provisions - Mechanisms to recover patent term lost during regulatory approval are available in many countries throughout the world. The August 2017 issue of Sterne Kessler’s Global Patent...more

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

by Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

by Knobbe Martens on

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the...more

First Circuit Holds that Scienter Requires Knowledge That Non-Disclosure Risked Misleading Investors, Not Just Knowledge of...

In Brennan v. Zafgen, Inc., — F.3d –, 2017 WL 1291194 (1st Cir., April 7, 2017), the First Circuit affirmed a District of Massachusetts decision dismissing claims against Zafgen, Inc., a biopharmaceutical developer, and its...more

EMA on optimising the development of advanced therapies

by Hogan Lovells on

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

Aralez’s YOSPRALA wins FDA approval

by Knobbe Martens on

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

Coming Soon? Part D Covered Drug Moves to Part B

by BakerHostetler on

We may soon see a provision in the 2015 final rule addressing the utilization of end-stage renal disease related drugs and biologics come into action in the next few months. Specifically, the oral-only drug Sensipar may...more

Off-Label Marketing – Industry Groups Step into the Breach

by Reed Smith on

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

Bloomberg/BNA Releases Report on Biopharma IPRs

As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been...more

Legislative Developments in Post-Grant Proceedings

by Fish & Richardson on

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

IPR Petitions in BioPharma Grow in Popularity

by Fish & Richardson on

The popularity of IPR petitions in the biopharma space has steadily grown since 2012 when IPRs were first introduced as a means of challenging the validity of patents. In 2013, 34 IPRs were filed, and the number nearly...more

Fish & Richardson’s Post-Grant Report 2015

by Fish & Richardson on

Since the enactment of the America Invents Act (AIA) in September 2012, post-grant proceedings have become an important part of litigation strategy, and in some instances are helping to reduce the time and cost associated...more

Healthcare & Life Sciences Private Equity Deal Tracker: Synlogic Secures $40 Million in Funding

by McGuireWoods LLP on

Synlogic has announced it has secured $40 million in series B financing. Synlogic, based in Cambridge, Mass., is a biopharmaceutical company focused on the development of a class of therapeutics, called synthetic...more

Polymer for Celiac Disease is Confirmed as Class IIb Medical Device in European Union

by Knobbe Martens on

According to a press release from the Israeli company BioLineRx, their novel polymer for treating Celiac Disease has been confirmed as a Class IIb medical device in the European Union (EU).  According to the company, the...more

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most...more

New Delaware Chapter 11 Filing – Kalobios Pharmaceuticals, Inc.

by Cole Schotz on

Kalobios Pharmaceuticals, Inc., a biopharmaceutical company that develops cancer treatments, has commenced a case under Chapter 11 of the Bankruptcy Code by filing a petition for relief with the U.S. Bankruptcy Court for the...more

Healthcare & Life Sciences Private Equity Deal Tracker: Allena Pharmaceuticals Secures $53 Million in Funding

by McGuireWoods LLP on

Allena Pharmaceuticals has announced it has secured $53 million in series C financing. Allena, based in Newton, Mass., is biopharmaceutical company focused on developing and commercializing nonsystemic oral protein...more

Intellectual Property Issues Under the Trans-Pacific Partnership | Orange County Business Journal

by Knobbe Martens on

The recently announced Trans-Pacific Partnership (TPP), a multi-national trade agreement between Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam, and the United...more

Orphan Drug Ruling Disrupts the 340B Program

by Polsinelli on

On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

Healthcare & Life Sciences Private Equity Deal Tracker: Syndax Secures $80 Million in Financing

by McGuireWoods LLP on

Syndax, based in Waltham, Mass., is a clinical stage biopharmaceutical company. It is developing entinostat, an investigational, targeted, epigenetic immunomodulator, as a combination therapy in multiple cancer indications...more

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