On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application...

On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment...

As we have previously reported, on June 21, 2023, the FDA accepted Xbrane's sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech's LUCENTIS (ranibizumab).

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen's complaint is filed under seal. Based on the list of 28 asserted patents...

On April 25, 2023, Bristol-Myers Squibb ("BMS") filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca's anti-PD-L1 antibody product, IMFINZI (durvalumab)...

On December 19, a German court invalidated CureVac's messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac...

Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc.

Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims...

As we enter the heart of Form 10-Q review season for calendar year-end companies and look ahead to Form 10-K review season early next year, a recent decision in a securities fraud class...

The law is the first to regulate collection of brain data, raising new questions for tech companies and privacy advocates.

At the NAREIT Law and Accounting Conference on March 20, 2008, Karen Garnett, Assistant Director in the SEC’s Division of Corporate Finance, announced that the staff at the SEC (the "Staff") has begun to issue comments requiring real estate companies to provide detailed descriptions of material properties and disclose property operating data in their Form 10-Ks.

On November 24, 2010, the U.S. District Court for the Southern District of Ohio dismissed ERISA breach of fiduciary duty claims arising from the continued holding of a bank’s stock in a 401(k) plan sponsored by the bank for its employees.

To this end, we have prepared a Form 10-K Checklist and Guide.

eaders from Shellworks, Emerson Collective, Dispatch Goods, and Galvanize Climate Solutions discuss their experiences building business focused on sustainability.

In this webinar, Caroline Bullerjahn, Tucker DeVoe, and Justin Ward from Goodwin, and Frank Schneider from Cornerstone Research will discuss key updates...

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President ("OIRA") has held stakeholder meetings...

In this Fintech Flash: Investor Insights issue, David Ajalat, Goodwin partner and Fintech practice co-chair, interviews TX Zhuo, General Partner at Fika Ventures.

On June 13, 2007, the IRS issued Notice 2007-55, stating its position that two common uses of the domestically controlled REIT structure do not achieve their intended result of allowing non-U.S. investors to avoid U.S. income tax and withholding under the Foreign Investment in Real Property Tax Act ("FIRPTA") with respect to gains from U.S. real estate.

Section 913 of the Dodd-Frank Act requires the SEC to deliver a study on the standards of care applicable to broker-dealers and investment advisers and to evaluate whether there are gaps or shortcomings to the existing legal and regulatory standards.

The American Tax Relief Act of 2012 included a number of real estate/sustainability provisions.