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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
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Looking Ahead to Washington State’s Legalized Marijuana Marketplace
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
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The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of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
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009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
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