FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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The Pharma Data

OCTOBER 27, 2020

To purchase DermSafe: Just search for “DermSafe” in Amazon.ca’s search engine or click on www.amazon.ca/shops/dermsafe. Ovation earns revenues from licensing and development fees, royalties, the sale of Invisicare to its licensees and now revenue from its own product sales. The product listing offered on Amazon.ca

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. Engineering precision nanoparticles for drug delivery. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

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The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. The pipeline development is leveraged through the Company’s proprietary target discovery engine called “DIAMOND.” relevant government policies and regulations relating to our industry.

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The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. 1 Noyce RS, et al. 2018) PLoS One.

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Biological Engineering mScarlet3: a brilliant and fast-maturing red fluorescent protein. CRISPRi-mediated tunable control of gene expression level with engineered single-guide RNA in Escherichia coli.

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Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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Codon

APRIL 19, 2023

To combat these threats, genetic engineers are making bananas that fend off fungi or ripen slower than natural varieties. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( Friedman’s engineered bananas stay yellow for more than a month after being plucked from a tree.

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Codon

APRIL 19, 2023

To combat these threats, genetic engineers are making bananas that fend off fungi or ripen slower than natural varieties. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( Friedman’s engineered bananas stay yellow for more than a month after being plucked from a tree.

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Drug Target Review

OCTOBER 10, 2024

By promoting partnerships between biobanks, research institutions, regulators, and industry, we can create networks for information sharing, streamline access to diseased donor material, and facilitate joint research initiatives. Furthermore, fostering cross-industry collaboration is essential.

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The Pharma Data

MARCH 4, 2021

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

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Codon

MAY 2, 2023

To use it, mosquitoes are bred in exactly the same way that I’ve already described, but with one major difference: Instead of infecting females with a bacterium, they are genetically engineered to express the Cas9 protein (one part of the CRISPR system ), while male mosquitoes are engineered to express guide RNAs.

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Codon

MAY 2, 2023

To use it, mosquitoes are bred in exactly the same way that I’ve already described, but with one major difference: Instead of infecting females with a bacterium, they are genetically engineered to express the Cas9 protein (one part of the CRISPR system ), while male mosquitoes are engineered to express guide RNAs.

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The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. This work has led to the identification of molecular components regulating crucial processes impaired in depression.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

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Codon

JULY 27, 2023

But for a recent paper out of Nanjing, China, researchers engineered another enzyme and showed that, when mixed with FAST-PETase, the two worked together to break down plastic twice as fast as the Texas enzyme alone. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. No longer.

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Codon

JULY 27, 2023

But for a recent paper out of Nanjing, China, researchers engineered another enzyme and showed that, when mixed with FAST-PETase, the two worked together to break down plastic twice as fast as the Texas enzyme alone. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. No longer.

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Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

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The Pharma Data

JANUARY 13, 2021

TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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Agency IQ

NOVEMBER 3, 2023

None of the products discussed thus far should be confused with “synthetic biotics” “Synthetic biotics,” also referred to as engineered living therapeutics , are bacteria that have been genetically altered to perform a specific function for diagnostic or therapeutic benefit. The regulation of dietary supplements in the U.S.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. To a fat-burning engine…. It was like the floodgates burst wide open…. And the fat just came pouring off. When your thyroid isn’t producing enough of its two main hormones – T3 and T4….

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Codon

APRIL 16, 2023

Codon Digest is my weekly roundup of research, news, and industry highlights about engineered biology. These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study.

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The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. About COMET-ICE.

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The Pharma Data

SEPTEMBER 8, 2020

is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. For more information, visit. www.novavax.com. and connect with us on. the United States.

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The Pharma Data

SEPTEMBER 8, 2020

Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Gene Expression and Regulation. Nature (2005).

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Nature (2005). & Xie X.S.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. However, licensed software can be a UCC sale of “goods.” Page Engineering Co. , at 77 (citation omitted). In United States v. Brown , 348 F.3d 3d 1200 (10th Cir. Buena Vista Home Entertainment Inc. 1536, 1542 (N.D.

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