Biotechnology Pharmaceutical Industry

News & Analysis as of

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

Court Report - May 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al. 3:16-cv-02356; filed April 26, 2016 in the...more

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY...more

To be prepared is half the victory

In the second in our series of alerts relating to drug pricing, we identify several considerations and potential actions that a pharmaceutical or biotechnology company can take to address the current headwinds impacting...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) 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...more

Legislative Developments in Post-Grant Proceedings

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

PTAB Statistics From Spring BIO IPCC Meeting

At the end of March, the Intellectual Property Counsels' Committee (IPCC) of the Biotechnology Innovation Organization (BIO) held its Spring meeting, convening in-house counsel and outside counsel involved in patenting the...more

[Webinar] Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs, and 505(b)(2) - April 14th, 9:00am...

Join Kurt Karst (Hyman, Phelps & McNamara, P.C.) (coauthor, "The FDA Blog") and Jeffrey Hovden (Robins Kaplan LLP) (coauthor, Generically Speaking) for a collaborative webinar. For generic drug companies, the biggest and...more

[Webinar] Recent Legal & Economic Developments That Affect Your Biotech Business - March 29th, 2:00pm EST

The greatest asset of a young biotech company is its intellectual property. Strategic decisions made during the initial organization and early growth of your company have a lasting impact on its success. In this webinar, we...more

Court Report - March 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc. 1:15-cv-00919; filed October 13, 2015 in the District Court of...more

Outlook for Patent Reform in 2016

With the final session of the 114th Congress under way, the likelihood of Congress taking up and passing comprehensive patent litigation reform legislation becomes more and more remote. From a timing standpoint alone, the...more

Court Report - February 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Actavis Laboratories UT, Inc. v. Par Pharmaceutical, Inc. 1:15-cv-00886; filed October 2, 2015 in the District Court of...more

Record breaker: US M&A in 2015

As the dust settles from the explosion of US M&A activity in 2015, it is fitting to reflect on the forces that fueled the boom and consider what last year’s trends may tell us about the year ahead. The record year...more

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

October 2015 IPO Market Review

The market produced 16 IPOs in October, bringing the total number of IPOs over the first 10 months of the year to 138. Gross proceeds for the month were $5.08 billion—the second highest monthly figure since September...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Court Report - October 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC 1:15-cv-06700; filed July 30, 2015 in the Northern District...more

High Court of Australia determines isolated BRCA1 gene not patentable in Australia

The High Court of Australia has unanimously overturned previous decisions from lower courts and has held that certain claims to Myriad's patent for isolated BRCA1 nucleic acid molecules are not patentable in Australia...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more

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