FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. 2003) , and Biogen lnt’l v.

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The Pharma Data

OCTOBER 19, 2020

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP).

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The Pharma Data

NOVEMBER 4, 2020

From 2003 to 2014, Mr. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B. XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.: Hugh Rogers, CEO and Director.

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. A company called LuminOre will soon bring copper-coated air ducts to the market. Not dissimilarly, biocidal products—those that destroy living things—must satisfy demanding regulations. Credit: Qi S.

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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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The Pharma Data

DECEMBER 15, 2020

Klisyri will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch. Mr. Peter Guenter, CEO of Almirall, stated, “We are delighted to partner with Athenex to market Klisyri in the U.S. Founded in 2003, Athenex, Inc.

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. The FDA recently concluded its work on a proposed rule focused on PMI.

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The Pharma Data

NOVEMBER 9, 2020

About NANOBIOTIX: www.nanobiotix.com Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

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Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 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. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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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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Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 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. TSCA risk management rules.

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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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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. These considerations led to several members finding ethical implications of keeping phenylephrine on the market.

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The Premier Consulting Blog

AUGUST 21, 2024

The major markets follow ICH guidelines, which affords harmonization of a significant portion of the chemistry, manufacturing, and controls (CMC) content. August 2021: [link] Pharmaceutical Regulations in Japan: Drug Development: [link] [link] [link] Stability conditions for WHO Member States by Region, March 2021: [link]

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Policy Prescription

MARCH 12, 2021

Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). State of Reform does a nice job covering this bill, but this post gives some underlying and important history.

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Drugs Regulations FDA Pharmaceuticals 52

Codon

NOVEMBER 1, 2024

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. In the pursuit of truth, science needs no market; technology, on the other hand, has no reality beyond its application and exists only in relation to the marketplace. billion letters’ of DNA within the human genome.

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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. The illicit marijuana market remains strong despite state laws legalizing marijuana. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 506 (N.Y.

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Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. 2002); Tracker Marine, L.P. Ogle , 108 S.W.3d

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Drug & Device Law

JANUARY 30, 2023

Mensing , 564 U.S. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

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Drug & Device Law

NOVEMBER 16, 2023

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). The court granted the motion and JAMA appealed. The appellate court reversed in Gibbons v.

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