Practical Cheminformatics

DECEMBER 4, 2022

In addition, the core code for extracting ring systems from molecules has been incorporated into the latest version of my pip installable useful_rdkit_utils package. In a 2012 paper, Peter showed how molecular descriptors can be used to characterize ring systems and perform similarity searches. Mühlbacher, J., Schuffenhauer, A., &

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The Pharma Data

AUGUST 3, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The Company has stopped enrollment in the Otezla arms of ongoing platform trials designed to evaluate the efficacy and safety of potential treatments for patients hospitalized with COVID-19.

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Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. That revised version remains in use today ( more on this below ).

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The Pharma Data

MARCH 31, 2023

Unitaid is working with implementing partners to ensure optimal use as part of a PrEP package that enables choice, and with the Coalition and other international partners to make long-acting PrEP options equitably accessible as quickly as possible.” Shionogi became a ViiV shareholder in October 2012. Access the sublicence agreements.

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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. Continuing this method may not scale.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. coli in mice. Paper by Sha G. in Nature.

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DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. coli in mice. Paper by Sha G. in Nature.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Digital Health Technologies Establish a secure cloud technology to enhance its infrastructure and analytics environment that will enable FDA to effectively receive, aggregate, store, and process large volumes of data from trials conducted using DHTs. But despite the law’s age, it is not yet fully operational.

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FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. 2012 WL 5932437 (N.D. 27, 2012), limited the undefined term “product” in an Alabama sales commission statute to tangible things, excluding franchise rights. 3d 316, 338 (Alaska 2012). 2012 WL 12886210, at *3 (C.D.

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Drug & Device Law

JUNE 6, 2022

2012), it had to apply the rule. 2012 WL 12848432, at *4 (E.D. 4, 2012) (no causation were, “[u]nderstanding the known risks,” the prescribing physicians testified that “they stand by their decisions to prescribe”), aff’d , 747 F.3d even with the addition of the language now found in the package insert”); McDaniel v.

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Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

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FDA Production Trials Government 69

Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. It turns out that our first post ended up describing the second worst case of the year. It also turns out the we were prescient, because the Louisiana Supreme Court ended up reversing the trial verdict for a number of the reasons we flagged.

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