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Licenses Pharmaceutical Industry Prescription Drugs

Hinshaw & Culbertson - Health Care

Don’t Jeopardize Your License: Ensure Compliance With California State Board of Pharmacy Notification and Reporting Obligations

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

Foley & Lardner LLP

Cancer Drugs: Deals and Licensing for Antibody-Drug Conjugates

Foley & Lardner LLP on

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

McDermott Will & Emery

California Law Requiring AG Notice for Retail Grocery and Pharmacy Transactions Now in Effect

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

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

Foley & Lardner LLP on

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

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

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

Goodwin

FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for...

Goodwin on

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

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