The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Rozibafusp alfa (AMG 570). Olpasiran (AMG 890).

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Agency IQ

OCTOBER 6, 2023

Data on these novel approvals is published throughout the year by both CDER and CBER. AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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Agency IQ

NOVEMBER 10, 2023

Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics. MoCRA also requires all marketed cosmetic products to be listed with the FDA by December 29, 2023.

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Alta Sciences

SEPTEMBER 20, 2023

In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ nonclinical site in Columbia, MO. Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences.

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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). After all, companies already have FDA-approved labels.

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Agency IQ

MAY 31, 2024

Shield is already available as a laboratory developed test (LDT), which allowed the sponsor to utilize a unique data set: Adherence The PMA for the Shield blood test was submitted to FDA in May 2023. Notably, CRC screening methods are currently available and have generally high performance (i.e.,

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Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. from 2021 to 2022, up to $625 million. Nature Biotechnology. Gene Therapy. Press release.

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. billion eggs in 2022 alone.

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Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Read our analysis of that rule here and here. ]

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The December calendar is packed with regulatory and industry meetings.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. cropland in 2022 — 300% year-over-year growth.” Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. cropland in 2022 — 300% year-over-year growth.” Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

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Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

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Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Legally the State of California – or, more accurately, a private litigant purporting to exercise state powers – has no such power, because warnings on OTC drugs must be approved by the FDA.

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Drug & Device Law

SEPTEMBER 12, 2022

9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post- Merck Sharp & Dohme Corp. Both propositions are well recognized, but Pfaff ties them together in one neat package. We recently received a copy of Pfaff v. Merck & Co. , 12-md-02331 (BMC), slip op.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. 2022 WL 4237528 (D. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.

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Drug & Device Law

MARCH 10, 2022

Kind LLC , 2022 WL 464149 (N.D. 2022), a decision holding that 21 U.S.C. § 3d —-, 2022 WL 390815 (N.D. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. 2022 WL 390815, at *3. Kashi Co. , — F.

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