News & Analysis as of

Biopharmaceutical Pharmaceutical Industry

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...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FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market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Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

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

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

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

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

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

Lessons From The 1st Biopharma Inter Partes Reviews

by Knobbe Martens on

Recently, the Patent Trial and Appeal Board issued its first set of final written decisions in three inter partes reviews relating to molecules in the large molecule biopharma space (IPR2013-00534, IPR2013-00535 and...more

Refashioning IP Asset Protection Strategies for Biotechnology and BioPharma Clients in View of the New Legal Realities of Subject...

by Thompson Coburn LLP on

In the 1970s, the biotechnology industry was in its infancy. Many academic researchers were developing faster, more efficient ways to clone and characterize gene products of interest, and companies arose to provide practical...more

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

GEN Compiles List of Top Biopharma R&D Spenders

Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012"). The biotech...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

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