life sciences – Duane Morris Life Sciences Law

December 12, 2023December 12, 2023 by Sean P. McConnell

Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction

On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.

Under the terms of the proposed licensing agreement between Genzyme Corporation, a wholly-owned subsidiary of Sanofi, and Maze, Sanofi would acquire an exclusive license to Maze’s glycogen synthase 1 products and related technology, including its candidate MZE001, a drug in development to treat the potentially fatal genetic order Pompe disease. According to a statement by Jason Coloma, Ph.D., Maze’s CEO, the FTC’s challenge “is the first time ever the FTC has moved to block a license of a Phase 1 investigational medicine.” The challenge seems consistent, however, with revised draft merger guidelines proposed by the FTC and Department of Justice that indicate that transactions “should not entrench or extend a dominant position” by, for example, “[e]liminating a nascent competitive threat.”

Continue reading “Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction”

June 26, 2023 by Duane Morris

Outlook for Life Sciences M&A: Industry Drivers Still Strong

In a recent GEN Edge article, Duane Morris partner Rebecca Guzman discussed the state of M&A activity in the life sciences.

“Following the most robust year for life sciences M&A on record, the sector saw a sharp decline in 2022 to levels below what we last experienced pre-pandemic. Many analysts pointed to supply chain issues, clinical development delays and other lingering effects of the COVID-19 pandemic as the cause. The 2021 catalysts of innovation following the pandemic breakout had finally worn off. On the surface, it appeared that key industry players had taken a step back, or even hit pause, but continued background activity tells a different story. While deal flow declined, the underlying drivers of M&A activity throughout 2022 (and continuing through today) remain strong.”

Read the full article at genengnews.com.

April 7, 2020 by Duane Morris

COVID-19 Therapies: Protecting Against Government Intrusion

As the COVID-19 pandemic continues to disrupt our lives, wreak havoc on our economy and force millions to social distance, shelter at home or even quarantine, scientists across the globe have turned their focus and expertise to developing new treatments and vaccines aimed at containing the effects of this virus.

The need for this life-saving work has never been more apparent or more urgent. We owe them a sincere debt of gratitude as our lives may literally depend on their success. And as the hard work of these scientists starts to bear fruit, the demand for these treatments will be so urgent and of such magnitude that no single company will likely be able to scale up, manufacture and distribute the treatment to all those in need.

The U.S. government has several options at its disposal to intervene―if necessary―to ensure a low priced treatment is rapidly made available to those in need.

To read the full text of this Duane Morris Alert, please visit the firm website.

February 6, 2020 by Duane Morris

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

May 16, 2019May 16, 2019 by Duane Morris

FDA Releases Draft Guidance on Voluntary Recalls – Comments Due June 24

The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA’s role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.

View the full Alert on the Duane Morris LLP website.

February 14, 2019 by Duane Morris

AdvaMed Releases Updated Code of Ethics, Effective 2020

The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.

The updated AdvaMed Code now includes “Key Concepts” at the beginning of each section, with visuals, graphics, callout boxes, examples, explanations and FAQs.

The AdvaMed Code provides medical technology companies with guidance on ethical interactions and relationships with healthcare professionals (HCPs) to ensure that medical decisions are based on the best interests of the patient.

Because the medical technology industry is highly divergent, the AdvaMed Code drafters recognize no single compliance program fits each company. Therefore, AdvaMed encourages companies to adopt an “appropriately tailored” ethics and compliance program, accounting for the specific types of risks that apply to their operations. Companies adopting the AdvaMed Code are encouraged to submit to AdvaMed an annual certification stating adoption of the AdvaMed Code and implementation an effective compliance program.

Read the full Duane Morris Alert.

November 9, 2018 by Duane Morris

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.

November 5, 2018 by Duane Morris

Five Good Habits of University Researchers Launching Spinouts

By Sandra G. Stoneman and Matthew C. Mousley

Photo of attorney Sandra Stoneman — Sandra G. Stoneman

Photo of attorney Matthew Mousley — Matthew C. Mousley

If you are a university researcher interested in launching a startup based on an invention developed in your lab, below is a list of some key guidelines to keep in mind as you start your company: Continue reading “Five Good Habits of University Researchers Launching Spinouts”

May 18, 2015 by Ryan Smith, Ph.D.

American Chemical Society Entrepreneurial Showcase 2015

The American Chemical Society held its annual Entrepreneurial Showcase in San Diego at Jannsen Labs (J&J Research Labs) in April 2015. ACS holds the biannual event, showcasing entrants from across the U.S., at Boston, Washington D.C., or San Diego.

The Showcase was a pitch event for emerging companies to present their technology, business plans, and answer some brief questions in front of angel investors, venture capitalists, corporate scouts, and Continue reading “American Chemical Society Entrepreneurial Showcase 2015”