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Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker. 

Join Us – Risks and Rewards of Accelerated FDA Pathways

March 20, 2018 | Blog | By Bridgette Keller

Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway.
Ken Cohen discusses how raising money for life sciences companies is different than for technology companies and gives entrepreneurs advice on how to finance and grow their life sciences company.

Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

February 20, 2018 | Blog | By Samantha Kingsbury

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. 
The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state's Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers.

Biosimilar Market Developments Continue Apace in 2018

January 18, 2018 | Blog | By Joanne Hawana

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

January 2, 2018 | Blog | By Joanne Hawana

Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products.
On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.
On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit.

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

March 20, 2017 | Blog | By Thomas Wintner

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to commercialize a biosimilar version of Genentech’s cancer drug, Avastin®.

Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

January 12, 2017 | Blog | By Adam Samansky, Joe Rutkowski

On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.

The Health Policy Commission’s Annual Cost Trends Hearings

November 1, 2016 | Alert | By Steven Baddour, Daniel Connelly, Julie Cox, Daria Niewenhous, Stephen Weiner, Maxwell Fathy, Elena Horvit, Parnia Zahedi

The Massachusetts Health Policy Commission conducted its fourth annual Cost Trends Hearing on October 17 and 18, 2016, under the requirements of Massachusetts’s 2012 health care reform legislation (“Chapter 224”).
As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

July 12, 2016 | Alert | By Bethany Hills, Joanne Hawana

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft guidance documents on different aspects of NGS-based diagnostic tests.
On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA).
The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35 U.S.C. § 101.

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

February 10, 2016 | Advisory | By Theresa Carnegie, Ellyn Sternfield, Lauren Moldawer

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).

Biosimilars and FDA Regulatory Webinar Recap

February 2, 2016 | Blog | By Joe Rutkowski

Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation.

Preparation for 2015 Fiscal Year-End SEC Filings and 2016 Annual Shareholder Meetings

February 2, 2016 | Advisory | By Megan Gates, Pamela Greene, Breton Leone-Quick

As our clients and friends know, each year Mintz Levin provides an analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission (the “SEC”) and their annual shareholder meetings.
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