News & Analysis as of

Due Diligence Pharmaceutical Industry

Goodwin

Life Sciences Licensing and M&A Update: Catching Up on Recent Decisions Affecting Commercially Reasonable Efforts Definitions and...

Goodwin on

Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

McDermott Will & Emery

[Webinar] Investing In Clinical Trial Site Management Organizations: Key Regulatory and Diligence Considerations - April 17th,...

Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations. Investing in pharma services is complicated, but our team...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Gardner Law

Getting What You Paid For: Acquisition Claims Considerations

Gardner Law on

While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create...more

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

Gardner Law on

Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

Sunstein LLP

The Nagoya Protocol: Regulating Research in the Wake of Biopiracy

Sunstein LLP on

What if I told you that there was a plant that could be used to treat diabetes, liver problems, ulcers, leukemia, and malaria? Understandably, you would want that plant to be studied and turned into medicine if possible....more

Mintz

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

Mintz on

As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

McDermott Will & Emery

[Event] HPE Miami 2022 - March 9th - 10th, Miami Beach, FL

McDermott Will & Emery on

Join us in person on Miami Beach for exclusive networking and to hear from leading investors helping shape the future of healthcare private equity. The annual HPE Miami event features a world-class faculty, offers creative...more

Womble Bond Dickinson

Opportunity Economy: Risks in Antitrust Enforcement

Womble Bond Dickinson on

Takeaways - ..The Biden administration’s recent executive order takes a hard line on limits to employment mobility, such as non-compete agreements. ..No-poach agreements—companies agreeing not to recruit each other’s...more

McDermott Will & Emery

HPE Miami 2021: Subsector Insights - Urgent Care

McDermott Will & Emery on

In recent years, the service offerings available at urgent care centers have expanded beyond traditional “urgent care” into several ancillary services. “Historically, urgent care was for urgent needs, such as flu or strep or...more

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

American Conference Institute (ACI)

[Webinar] Special Guidance on DEA's COVID-19 Response Concerning the Production of Controlled Substance Medications - June 3rd,...

Complimentary webinar with the DEA on Controlled Substances! During this global pandemic, the Diversion Control Division is working to assure that there is an adequate supply of controlled substances in the United States,...more

McDermott Will & Emery

[Webinar] Diagnostics, Antibody Testing and Vaccines: Global Outlook on Life Sciences COVID-19 Advances and Evolving Deal Trends -...

Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more

Fenwick & West LLP

Delaware Reaffirms High Bar for Establishing a Material Adverse Effect

Fenwick & West LLP on

In the first case following Akorn v. Fresenius to rule on a party’s entitlement to terminate a merger agreement on the basis of a material adverse effect (MAE), the Delaware Court of Chancery ordered Boston Scientific...more

McDermott Will & Emery

Collaborative Transformation: Life Sciences Partnerships – Delivering Deals that Work

McDermott Will & Emery on

The life sciences marketplace has been ripe for collaboration for the past decade, but new players, new technologies and new regulations are changing the space. Traditional life sciences companies are working together in new...more

McDermott Will & Emery

International News Life Sciences - Winter 2018

McDermott Will & Emery on

Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to comply. ...more

Dechert LLP

Recent Delaware Case Makes First Finding of "Material Adverse Effect": Key Takeaways

Dechert LLP on

The recent decision of the Delaware Court of Chancery in Akorn, Inc. v. Fresenius Kabi AG et. al is the first time a Delaware court has found a material adverse effect in the M&A context, and reinforces current Delaware law...more

Akin Gump Strauss Hauer & Feld LLP

United States Intervenes in Suit Against Private Equity Firm Based on Health Care Portfolio Company's Alleged False Claims Act...

• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more

Troutman Pepper

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

Hogan Lovells

FTC Takes Another Look at Merger Remedies

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On 3 February 2017, the U.S. Federal Trade Commission (FTC) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to 2012. Nearly two decades after it issued a similar...more

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