Biologics

01
Sep

Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Porter attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]

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09
May
Law and justice concept

Is Help on the Way? Contrast Agents and Drug Device Conundrum May Be Legislated Away

In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal.  This court decision dealt with […]

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09
Dec

FDA Finalizes Guidance on Annual Reportable CMC Changes for Specified Biologic Products

In today’s Federal Register (here), the FDA announced the availability of a final guidance for chemistry manufacturing and control changes (CMC) that may be reported in an annual report (AR).  CMC changes that may be submitted in an annual report are considered minor changes.  The FDA says, “This final guidance updates the draft guidance of […]

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09
Nov

AAM GRx-Biosims Day 1 – Afternoon, Part II

The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage.  The […]

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29
Jul
First

Big Day in the Biosimilar World – First Interchangeable Product Approved for Insulin!

Everyone knew this day would come and it has been a long time in coming.  Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product.  An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider. According to the FDA announcement, “Semglee (insulin glargine-yfgn) […]

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24
Feb
Corona Virus covid-19 illustration

Staying Ahead of SARS-CoV-2 Variants as You Develop Your Monoclonal Antibody Products

As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals.  Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population.  The good news is that the FDA […]

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11
Dec

NEWS FLASH – COVID-19 Vaccine Vote from the Advisory Committee Meeting

Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine.  I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study. […]

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