Drug Target Review

FEBRUARY 28, 2024

Chem Immunol Allergy 86:151-183 (2005). Normality sensing licenses local T cells for innate-like tissue surveillance. Human γδ TCR repertoires in health and disease. Cells 9(40):800 (2020). Holtmeier W, Kabelitz D. gammadelta T cells link innate and adaptive immune responses. Kalyan S, Kabelitz D. Cell Mol Immunol 10(1):21-9 (2013).

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The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs.

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The Pharma Data

MARCH 20, 2023

Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments.

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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. Nature (2005). Nature (2005). PNAS (2005). 📙 Seminal Papers to Get You Up to Speed Mostly open-access; some are paywalled.

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The Pharma Data

NOVEMBER 29, 2020

To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. 2005; 49(3):873-883. HOOKIPA’s non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation.

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Agency IQ

JANUARY 26, 2024

In response to this report, FDA researchers published extensive data on the SLEP program, reviewing the findings for 122 drugs products (3005 different lots) evaluated by the program between 1986 and 2005. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2005; 172; 149–60. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. J Intern Med 2012;272:121–32. 7 Wenzel S.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2005; 172: 149-160. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. 2019;12(5):539-549. Wenzel S.

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Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects. On September 14, 2018, the U.S.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2005) (no causation where prescriber “testified that he selected. . . Wyeth , 72 Pa. 2d 141 (Pa.

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Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

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Drug & Device Law

JANUARY 4, 2024

The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8). “To Alabama State Board of Pharmacy , 61 F.4th 4th 902, 905 (11th Cir.

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Drug & Device Law

FEBRUARY 2, 2023

Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law.

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