Drafting Consumer Breach Notices — From a Litigation Perspective - Unauthorized Access Podcast
Landlord and Tenant Lease Risk Reduction for the Cannabis Industry
Insurtech Briefly Podcast: Licensing, Google and Lead Gens
Edible Bites Episode 7: Oregon Psilocybin Services Act, Measure 109 Overview and Licensure
PODCAST: GovCon Perspectives - Are You Interested in Investing in a Company With a Federal Firearms License (FFL)?
Bill on Bankruptcy: Supreme Court Cases Will Have Wide Impact
Polsinelli Podcast - Avoiding Professional Liability
Patent Series: Protecting inventions
License to travel: how regulation is benefiting business abroad
Uncertainty Surrounds Illinois’s Nationally-Watched Collaborative Legislation On Fracking
Harlem Shake's Copyright Issues
Craft Beer Boom in Michigan
Unlocking Your Cell Phone Is Now Illegal, but Not for Long
Weekly Brief: New DOJ Tact Pushes Bank Subsidiaries To Admit Guilt
Looking Ahead to Washington State’s Legalized Marijuana Marketplace
Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more
On January 1, 2024, Assembly Bill 853 (AB 853) went into effect in California. It requires parties to a transaction involving retail grocery firms or retail drug firms to file a notice with the California attorney general 180...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more
On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes...more
In response to the opioid crisis, the Drug Enforcement Administration (DEA) is cracking down on pharmacies, pharmacists, and prescribers by leveraging an old enforcement weapon: revocation of controlled substance...more
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more