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
This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...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
Nearly one hundred life sciences professionals convened at Mintz’s Boston office last week for an event we hosted in partnership with the LES (Licensing Executives Society). I moderated a panel, “Structuring Your Life...more
This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A. In 2023, there were 240 reported life sciences licensing deals in China,...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
In the latest episode of the Founder Shares podcast, I had the pleasure of diving into the dynamic universe of university licenses with Dan O'Korn, a seasoned life sciences attorney specializing in licensing and development...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
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by...more
At a special called meeting on January 4, 2023, the Kentucky Board of Pharmacy (“Board”) was set to address public comment on new regulation, 201 KAR 2:460, and proposed amendments to 201 KAR 2:030. The amendments to 201 KAR...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
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
On September 30, 2019, the Minnesota Department of Commerce (Department) published in the State Register its Request for Comments relating to an upcoming rulemaking relating to Pharmacy Benefit Manager (PBM) Licensure and...more
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”)....more
The D.C. Circuit recently affirmed a lower court’s decision upholding regulations adopted by the Federal Trade Commission (FTC) requiring a Hart Scott Rodino (HSR) Act premerger notification filing for transfers of patent...more
In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity ...more
The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more
Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more
The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new...more
The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more
The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more
In This Issue: Investor Q&A; Key Regulatory Issues for Strategic Life Sciences Partnerships in China; Compulsory Patent Licensing in China; and New Developments on the “Patentable Subject Matter” Requirement of U.S....more
Many Canadian businesses are involved in researching and developing cutting-edge technology in a number of areas including: information technology, high-tech, life sciences, pharmaceuticals, clean technology, environmental...more