Duane Morris – Page 3 – Duane Morris Life Sciences Law

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.

June 8, 2023 by Duane Morris

Silica Exposure-Related Lawsuits in California Exploding

Silica is an abundant mineral found in materials including sand, stone, and concrete. While serving as a principal component of glass, cement, and ceramics, silica also presents an increasingly pertinent issue for those with interests in toxic torts, as well as businesses involved in the manufacturing or distribution of silica products: occupational exposure to airborne silica, a leading cause of silicosis and lung cancer.

Silicosis is a severe, incurable lung disease that is often fatal. Upon inhalation of fine particles created through workers’ manipulation of the material, small amounts of silica become trapped in the lungs, causing the scarring of lung tissue. Resulting effects are severe, often requiring lifelong care and a possible lung transplant.

Cases commonly appear among those working in construction or mining, and symptoms can present after only a few years of occupational exposure. More often than not, workers use little to no protective equipment, leaving them vulnerable to inhalation of the harmful substance. With the number of silicosis cases on the rise, the issue has been denoted an “emerging epidemic” constituting a “public health problem of great urgency.”

To read the full text of this blog post by Duane Morris partner Robert Kum, please visit the Duane Morris Products Liability Blog.

May 19, 2023 by Duane Morris

Supreme Court Affirms Federal Circuit Ruling Regarding Satisfaction of Enablement Requirement

On May 18, 2023, the Supreme Court of the United States issued its opinion in Amgen, Inc. v. Sanofi, clarifying the standard of satisfying the enablement requirement, in particular, for broad functional genus claims. The Court, in a unanimous decision affirming the Federal Circuit’s holding, focused on whether the specification enabled the full scope of the invention to be practiced.

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

March 6, 2023 by Duane Morris

US FDA Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris.

The move will allow the FDA to implement MoCRA more efficiently and effectively, she told Chemical Watch. To this end, the agency “anticipates closer collaboration between cosmetics and other FDA subject matter experts” in the Center for Drug Evaluation and Research and the Office of Women’s Health, she said.”

To read the full text of this article, please visit the Chemical Watch website (subscription required).

February 22, 2023February 23, 2023 by Duane Morris

Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment

On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.

To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.

February 14, 2023 by Duane Morris

Latin America Sees Increased Enforcement of U.S. Foreign Corrupt Practices Act

The United States enacted the Foreign Corrupt Practices Act (FCPA) in 1977 to criminalize the bribery of foreign government officials in exchange for new business or maintaining old business. The risk to Latin American companies is that the FCPA is applicable to not only U.S. citizens and companies, but also to foreign persons residing in the United States and foreign companies listed on U.S. exchanges. Moreover, the FCPA also applies to foreign firms and persons who have substantial contacts in the United States. Importantly, enforcement officials may hold U.S. companies liable for the actions of their foreign subsidiaries in cases where the subsidiary acts as an agent of the parent company.

Read the full Alert on the Duane Morris LLP website.

January 23, 2023 by Duane Morris

Rick Ball and Coleen Hill to Speak at MassMedic Regulatory Roundup Event

Duane Morris attorneys Rick Ball and Coleen Hill will speak at the MassMedic Regulatory Roundup Event webinar on February 16, 2023, starting at 9 a.m. Their presentation is titled “Recent Developments on the ‘Fraud on the FDA’ Theory of False Claim Liability” at 10:45 a.m.

This program is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.

For more information or to register, please visit the MassMedic website.

January 4, 2023 by Duane Morris

Year-End Appropriations Bill Overhauls FDA Cosmetics Authority

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since 1938. Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation Act contains a number of key provisions, requirements and dates for compliance.

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

November 9, 2022 by Duane Morris

Board Directors Beware: U.S. Antitrust Agencies Ramp Up Enforcement of Interlocking Directorates

The Antitrust Division of the Department of Justice (DOJ) has indicated a recent interest in enforcing Section 8 of the Clayton Act, which prohibits individuals from serving on boards of competing corporations, known as “interlocking directorates.” (See 15 U.S.C. § 19.) Assistant Attorney General Jonathan Kanter has called Section 8 an “important but underenforced” antitrust law. After DOJ announced a focus on Section 8, the agency reported that seven board members announced their resignations in response. Since then, DOJ has continued its focus on Section 8, issuing civil investigative demands and confidential investigation letters to firms, including private equity funds and investors. Life sciences companies, and companies that invest in the life sciences industry, should be on the lookout for interlocking directorates, as there is empirical evidence suggesting that the industry is particularly at risk of a Section 8 investigation.

Read the full text of this Alert on the firm website.

October 21, 2022 by Duane Morris

DOJ Announces an Enhanced Approach to Corporate Criminal Enforcement

On September 15, 2022, Deputy Attorney General Lisa O. Monaco of the Department of Justice (DOJ) delivered a speech at New York University addressing new guidance on corporate criminal enforcement. Her speech made it clear that DOJ is prioritizing investigations and prosecutions against corporate entities. DOJ’s approach in this area is fundamentally grounded in individual accountability and corporate responsibility. Building off those ideas, the new guidance provides for: (1) increased focus on individual liability; (2) consideration of the full criminal, civil and regulatory record of any company when deciding the appropriate resolution; (3) expanding voluntarily self-disclosure programs across DOJ; and (4) the consideration of compensation systems that reward or deter compliance when evaluating the strength of a company’s compliance program. Monaco also announced increased transparency and consistency by DOJ when determining issues related to monitors. DOJ intends these policies to communicate to corporate entities that it is “not accepting business as usual” and that personal liability and the specifics of a corporation’s cooperation and integration of compliance programs will be heavily scrutinized in criminal corporate prosecutions.

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