Life Sciences Pharmaceutical Industry

News & Analysis as of

MoFo BioMeter, Volume 5, Issue 1

The full-year 2015 BioMeter paints the picture of a strong year for biotechnology, but deeper analysis shows a cautionary trend. The average BioMeter value for the entire year across all transactions reporting up-front...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

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

A Look at Tax Issues of the Life Sciences and Tech Industries

Wolters Kluwer had the opportunity this past week to sit down with Pepper Hamilton LLP partners Todd Reinstein, Washington, D.C., and Joan Arnold, Philadelphia, to discuss current tax issues particularly relevant to the life...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

Celltrion Opposes Expedited Trial and Delayed Launch Date

On Monday, Celltrion filed a response to the letter Janssen submitted to the Court on April 12 requesting an expedited trial schedule. Celltrion maintains that Janssen improperly argues the merits of Janssen’s claim of...more

Alert: Life Sciences Company Hit with $4 Million SEC Penalty

On March 29, the US Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay a $4 million penalty to settle fraud charges that it failed to...more

Guest Post: Coalition for 21st Century Medicine Comments on Expected Ariosa Cert Petition

The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is...more

European Life Sciences Review: Issue 2

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

AGG Food and Drug Newsletter - February 2016

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

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Obesity and other Metabolic Disorders

The gut microbiome, a collection of microbes living in the gastrointestinal tract, has emerged as an attractive target for pharmaceutical intervention for the treatment of a variety of disorders. This is the fourth article...more

Life Sciences. Major Russian legislation changes for 2015

1. Entry into force of the set of amendments to the Federal Law on the Circulation of Medicines that were approved in December 2014 - Federal Law No. 429-FZ of December 22, 2014 on Amendments to the Federal Law on the...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...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

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

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

Life Sciences Spotlight - Asia Pacific - Issue 6, 2015

Trends and developments in cyber security and data protection: Why pharma and life sciences companies should take action. Pharmaceutical and life sciences companies are increasingly the target of cyber-attacks and...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

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

International Life Sciences Data Transfers After Schrems

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

Compensation to Human Clinical Study Participants: A (Very) Informal Survey

At least once a month, life science clients reach out to us to ask us about best practices on a particular topic or to benchmark a proposed activity against what others in the industry might be doing. One such request,...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

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