The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

Treatment 40

Treatment Disease FDA Therapies 40

Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. The EPA received a petition for reconsideration of the 2006 rulemaking and, in 2007, EPA announced its reconsideration of several aspects of the rule.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

MARCH 29, 2024

EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). The Perc Dry Cleaning NESHAP, 40 CFR part 63, subpart M, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on September 22, 1993 (58 FR 49354).

Regulations 40

Regulations Compliance Production Government 40

Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

Laboratories 137

Laboratories Research Disease Science 137

Agency IQ

FEBRUARY 2, 2024

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This routine Methods Update Rule (rMUR) was proposed in February 2023.

Regulations 40

Regulations Compliance Engineering Government 40

Codon

FEBRUARY 9, 2025

In 2006, The Howard Hughes Medical Institute's Janelia Research Campus initiated FlyEM , a project aiming to reconstruct the complete connectome of the Drosophila brain using state-of-the-art EM and computational tools. .” “Once we have these maps,” Payne says, “you can start changing people's lives by using them.”

Research 110

Research Disease Engineering Regulations 110

Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. Researcher Jerome Horwitz at the Michigan Cancer Foundation developed it as a potential cancer treatment by chemically-modifying thymine, a DNA building block. By February, the U.S.

Clinical Trials 76

Clinical Trials Virus Vaccine DNA 76

Drug & Device Law

JULY 31, 2023

2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F. Ohio 2006) (“the same reasoning is even more appropriate in this context of broadcast media”). In Gorran v.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 4, 2023

Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim. 2006), aff’d by equally divided court , 552 U.S. Warner-Lambert & Co. , 3d 85, 98 (2d Cir.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Lineberger v. Wyeth , 894 A.2d

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. at *3 (emphasis original).

Testimonials 59

Testimonials Doctors Production Laboratories 59