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  1. Services
  2. Pharmaceuticals & Medical Devices

Insights on Pharmaceuticals & Medical Devices

144 total results. Page 2 of 6.

Health Care Counsel Blog
Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory Opinion 22-07
May 20, 2022
Douglas A. Grimm, Gayland O. Hethcoat II

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions.

Events
IBA 8th Annual World Life Sciences Conference
May 17, 2022
Alexander H. Spiegler

ArentFox Schiff Intellectual Property Partner Alex Spiegler will present at the International Bar Association (IBA) 8th Annual World Life Sciences Conference.

Health Care Counsel Blog
OIG Issues Advisory Opinion Approving Biopharmaceutical Manufacturer’s Sponsorship of Free Genetic Testing and Counseling
May 5, 2022
Douglas A. Grimm, Gayland O. Hethcoat II

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the Requestor’s provision of free genetic testing and counseling.

Events
Paragraph IV Disputes Conference 2022
April 26, 2022
Richard J. Berman, Sailesh K. Patel, Imron T. Aly, Kevin M. Nelson, Bradford C. Frese, Taniel E. Anderson

ArentFox Schiff is sponsoring the ACI Paragraph IV Disputes Conference and Rich Berman and Sal Patel will present.

Events
HDA 2022 Distribution Management Conference
March 8, 2022
Stephanie Trunk

Health Care Partner Stephanie Trunk is presenting at the Healthcare Distribution Alliance’s 2022 Distribution Management Conference on March 8.

Health Care Counsel Blog
Nevada To Begin Enforcing Pharma Sales Force Registration Law
February 23, 2022
Stephanie Trunk

Back in 2017, the state of Nevada passed a sweeping bill into law that addressed not only drug pricing transparency, but also reporting obligations applicable to pharmacy benefit managers and non-profit organizations and also imposed certain requirements on manufacturer sales forces.

Consumer Products Watch
Trending in Tort Law Part II: Courts Address the Growing Use of Public Nuisance in Mass Torts
January 11, 2022
James D. Cromley, Elizabeth Runyan Geise

Since prescription opioids were first introduced for pain treatment in the 1990s, the number of drug overdose deaths has quadrupled, and more than a half million Americans have died from an overdose involving an opioid.

News
Nelson Quoted on Viability of Carveouts in Generic Drug Marketing
January 6, 2022
Kevin M. Nelson

Partner Kevin Nelson was quoted on a Federal Circuit Court ruling in GlaxoSmithKline v. Teva, which has caused concern among some generic drug manufacturers regarding their ability to sell generic drugs that leave patent-protected uses off the label.

Press Release
LMG Life Sciences Recognizes the Firm and 3 Partners in 2021
September 30, 2021

Schiff Hardin has been ranked “Recommended” by LMG Life Sciences in the Hatch-Waxman Patent Litigation (Generic) category of its 2021 guide.

Events
Trends in Hatch-Waxman Litigation
September 2, 2021
Sailesh K. Patel

IPR Connexion

Events
Section 112 Considerations on Pharmaceutical Patents and Litigation
September 1, 2021
Sailesh K. Patel

IPR Connexion

Press Release
Schiff Counsels Altaris on its $1.55B Acquisition of Padagis
July 7, 2021

Schiff advised Altaris Capital Partners, LLC on its acquisition of Padagis LLC, formerly the generic prescription pharmaceuticals business of Perrigo Company plc, for $1.55 billion.

Press Release
Firm and Four Attorneys Ranked in the 2021 IAM Patent 1000
June 30, 2021

Schiff Hardin LLP is proud to announce that the firm and four of its attorneys have been ranked in the 2021 edition of IAM Patent 1000: The World’s Leading Patent Professionals, a guide that identifies top patent professionals based on 1,800 interviews with private practice and in-house professionals.

Press Release
The Legal 500 US 2021 Ranks Four Practices, 12 Attorneys
June 9, 2021

Schiff Hardin LLP is pleased to announce that four of the firm’s practice groups have been recognized in The Legal 500 United States 2021 guide, which provides a nationwide analysis of law firms that provide cutting-edge and innovative advice.

Press Release
Schiff Counsels CNS Pharmaceuticals on $11.5M Public Offering
March 8, 2021

Schiff Hardin advised CNS Pharmaceuticals, Inc. in connection with its public offering of 5,750,000 shares of common stock and 2,875,000 warrants to purchase common stock for gross proceeds of $11.5 million.

Press Release
Schiff Advises Altaris on its Agreement to Acquire $1.55 Billion Perrigo’s Prescription Pharmaceuticals Business
March 1, 2021

Schiff Hardin LLP represented Altaris Capital Partners, LLC, a private investment firm focused on the healthcare industry, in its agreement to acquire Perrigo Company plc’s prescription pharmaceuticals business (Rx) for $1.55 billion.

News
Nelson Quoted on Patent Thicket Appeal that Could Alter Biosimilar Landscape
February 23, 2021
Kevin M. Nelson

Law360

News
Nelson Quoted on AbbVie Humira Patent Thicket and Settlements Seventh Circuit Appeal
February 19, 2021
Kevin M. Nelson

Pharmaceutical Technology

Press Release
Schiff Acted as Underwriters’ Counsel in GT Biopharma’s $23.7M Nasdaq Up-Listing Offering
February 17, 2021

Schiff Hardin LLP advised Dawson James Securities, Inc. as underwriter in GT Biopharma, Inc.’s Nasdaq up-listing offering of 4.3 million units.

Press Release
Schiff Advises Moleculin Biotech, Inc. on its $78M Public Offering
February 10, 2021

Schiff Hardin LLP advised Moleculin Biotech, Inc. in connection with its public offering of 16,414,736 shares of common stock for gross proceeds of approximately $78 million.

Health Care Counsel Blog
Early Christmas Presents for Pharmaceutical Manufacturers: Court Grants Temporary Ban on Medicare Part B Most Favored Nations Reimbursement Rule
December 24, 2020
Stephanie Trunk

On December 23, 2020, Judge Catherine Blake of the US District Court for the District of Maryland put in place a 14-day restraining order while she considers whether to issue a preliminary injunction. She plans to consider whether the Centers for Medicare & Medicaid Services rulemaking was adequate

Health Care Counsel Blog
HOPPS and Physician Fee Schedule Proposed Rules: What Pharmaceutical and Device Manufacturers Need to Know
August 21, 2020
Stephanie Trunk

CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.

Alerts
White House Issues Executive Orders Addressing Drug Pricing
July 30, 2020
Stephanie Trunk

The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” 

News
A New Antitrust Approach After Humira 'Patent Thicket' Ruling
June 26, 2020
Kevin M. Nelson

Law360

Health Care Counsel Blog
Proposed ‘Kitchen Sink’ Medicaid Rule Could Bring Changes for Pharmaceutical Manufacturers
June 24, 2020
Stephanie Trunk

Pharmaceutical manufacturers and other stakeholders should submit comments on the Proposed Rule by July 20, 2020.

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