2001, Licensing and Regulations - Drug Discovery Digest

2001

Licensing

Regulations

Gamma delta T cells: a rising star in cancer therapy

Drug Target Review

FEBRUARY 28, 2024

Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells. Science 294(5542):605-609 (2001). Kabelitz D, Serrano R, Kouakanou L, et al. Cancer immunotherapy with γδ T cells: many paths ahead of us. Cell Mol Immunol 17:925-939 (2020).

Therapies

Therapies Engineering Molecular Biology Science

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

Packaging

Packaging Licensing Licensing Regulations

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Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA

FDA Trials Therapies Regulations

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Article EMA Thank You What Europe’s proposed Data Act means for device manufacturers: A deep dive

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.

Regulations

Regulations Government Production International

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science

Science FDA Production Packaging

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

The Pharma Data

JANUARY 13, 2021

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. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583 11):1583 (2004) 6 Karpusas M, et al. Structure.

Pharmaceuticals

Pharmaceuticals Small Molecule Vaccine Protein Expression

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

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.

Regulations

Regulations Compliance Production Science

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. January 29, 2024).

Regulations

Regulations Production FDA Approval Drugs

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

Vaccine

Vaccine FDA FDA Approval Production

FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

FDA

FDA Nurses Production Regulations

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. However, licensed software can be a UCC sale of “goods.”

Production

Production Trials International Government

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA

FDA FDA Approval Testimonials Vaccine

Court Denies Motion to Dismiss Based on Implied Preemption

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 341 (2001), the U.S.

FDA

FDA Licensing Licensing Regulations

Court Denies Motion to Dismiss Claims Targeting a Biologic

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Plaintiff received the biologic just months after it had been licensed by the FDA. 341 (2001). 337(a), which applies to all products regulated under the FDCA, not 21 U.S.C. See 42 U.S.C. § See 21 C.F.R. Albrecht , 139 S.

FDA

FDA FDA Approval Licensing Licensing

Gamma delta T cells: a rising star in cancer therapy

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

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Trending Sources

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Webinars

Article EMA Thank You What Europe’s proposed Data Act means for device manufacturers: A deep dive

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

A Texas Mess

FDA and Off-Label Communication – Getting Closer to Truth

How the Fifty States View Electronic Data as a “Product”

The FDA and Feasible Alternative Designs

Court Denies Motion to Dismiss Based on Implied Preemption

Court Denies Motion to Dismiss Claims Targeting a Biologic

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