New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. This suggests that the CDK7 enzyme complexes are involved in multiple functions in the cell: cell cycle control, transcription regulation and DNA repair. Oct 1 5;24(20):2303-16, 2010; Blazek et al., Konig et al.,

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Production DNA RNA Regulations 62

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. It took two years to produce the phage cocktail to standards that regulators were happy with.

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Therapies Virus DNA Clinical Trials 135

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. 11):1583 (2004) 6 Karpusas M, et al. Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. CHATHAM, N.J., Holding Corp.

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Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. In October 2020, Roche announced a partnership with Atea Pharmaceuticals to jointly develop the investigational compound AT-527. About Roche.

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Treatment Virus Clinical Trials Pharmaceuticals 52

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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Regulations Compliance Production Science 40

Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Compliance Science Marketing 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Regulations Compliance Production Government 40

The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19.

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Clinical Trials Virus Trials FDA 52

New Drug Approvals

APRIL 14, 2025

PATENT Arena Pharmaceuticals, Inc.WO2023172685 Arena Pharmaceuticals, Inc., 1] [3] It is being developed by Longboard Pharmaceuticals. [1] 5] [6] [7] References ^ Jump up to: a b c d e f “Bexicaserin – Longboard Pharmaceuticals” AdisInsight. Menendez de la Prida L, Gal B (June 2004). 2017.00060.

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Clinical Trials Pharmaceuticals Pharmacokinetics Treatment 62

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Government Compliance Science 40

Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Janssen Pharmaceuticals, Inc. ,

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Compliance Government Production FDA Compliance 52

Drug & Device Law

OCTOBER 23, 2023

Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ). Ortho Pharmaceutical Corp. , 2004); Sheetz v. 2004) (Posner, J.); at 328 (citation omitted). 2023 WL 6216933, at *7. 2d 352 (Ill. 2015); E.L.T.,

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Government Regulations FDA Nurses 59

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. Brown , 348 F.3d

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Production Trials International Government 52

Drug & Device Law

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. 2004 WL 2827710, at *6 (Del. 15, 2004); Goodridge v. 15, 2004); Goodridge v. 2004) (“the trial judge” is “a gatekeeper of expert opinion”). Cooper , 496 P.3d 3d 430, 431-32 (Colo. 2021) (quoting Daubert v.

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Testimonials Trials Science Government 59