FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

FDA responded to the Citizen Petitions on February 27, 2004, and issued a Press Release on March 2, 2004 (yeah, we saved that as well) concerning the PIV List. 2000P-1556) was submitted by Hyman, Phelps & McNamara, P.C.,

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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Sygnature Discovery

JULY 31, 2023

Additionally, the company provides protein chemistry services and offers crucial knowledge-based expertise in structural biology at the initial stages of drug discovery to global biotech and pharmaceutical companies. Its staff of over 1,000, which includes 900 scientists, partners with global pharma, biotech and NFP organisations.

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The Pharma Data

SEPTEMBER 15, 2020

She continued her career as a health economist and in 2004, Seredina joined S-Clinica. Konneh has worked extensively in drug development for over 20 years, initially as a researcher at Novartis and in business consulting in the pharmaceutical practice of Accenture. Matthew Konneh, holds a PhD and MBA in Cardiovascular Pharmacology.

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Sygnature Discovery

SEPTEMBER 25, 2023

Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents. Its staff of over 1,000, which includes 900 scientists, partners with global pharma, biotech and NFP organisations.

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Sygnature Discovery

NOVEMBER 13, 2023

Martin LeBlanc is a seasoned pharmaceutical executive with a successful track record in driving innovation and growth within the life sciences sector. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents.

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Sygnature Discovery

MARCH 24, 2022

When DMPK scientist Lynette Ongeri joined Sygnature this month, she unknowingly helped us reach a landmark we couldn’t be prouder of… Sygnature Discovery – or Sygnature Chemical Services Ltd, as it was known then – opened its doors in 2004 with five colleagues. Back to Lynette, though.

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The Pharma Data

NOVEMBER 8, 2020

Absorption Systems is a leading scientific, non-clinical CRO that provides pharmaceutical, biotech, medical device companies and regulatory agencies with research and testing for small and large molecules, cell and gene therapies, ocular and medical device products. BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

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National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

This challenge may account for part of the reluctance of the pharmaceutical industry to invest in developing new medications aimed at reducing drug use. 2004 Jan;65(1):105-14. Curr Treat Options Psych. 2015;2:11321. link] Chung T, Maisto SA, Cornelius JR, Martin CS. J Stud Alcohol. doi: 10.15288/jsa.2004.65.105. 2004.65.105.

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Practical Cheminformatics

JANUARY 8, 2024

While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns. A 2004 paper by Vigers and Rizzi proposed a similar strategy for docking studies. For classification models, the participants reported a median 2.5-7.5% What’s old is new again.

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Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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Agency IQ

NOVEMBER 10, 2023

Fees supplemental to the basic fees can be collected for authorization of additional strengths and pharmaceutical forms. New tasks and amendments to existing tasks through the adoption of the 2004 Founding Regulation for the European Medicines Agency (EMA) increased fee amounts as well.

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The Pharma Data

NOVEMBER 15, 2020

Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004.

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Molecular Design

JANUARY 27, 2019

It is also worth pointing out that LE was touted as "useful" even as it was introduced in a 2004 letter to Drug Discovery Today and all three coauthors of that seminal contribution to the medicinal chemistry literature appeared to be blissfully unaware of the nontrivial dependency of their creation on the standard concentration.

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New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). Patent WO-2022130304 PATENT WO2023107861 [link] In some embodiments, the compound of formula (I) is (E)-N-(5-(3-(l-((5-cyclopropyl-lH-pyrazol-3-yl)amino)-3-methyl-l-oxobutan-2-yl)phenyl)pyridin-2-yl)-4-morpholinobut-2-enamide or a pharmaceutically acceptable salt or a stereoisomer thereof (Compound 44).

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Drug Target Review

JUNE 21, 2023

An example is Vertex Pharmaceuticals’ approved treatment for cystic fibrosis (Kalydeco) 6 , which counteracts the outcome of a specific mutation thereby stabilising the defective CTFR protein, and restoring proper pulmonary function. 2004 Feb 6;303(5659):808-13. Global mapping of the yeast genetic interaction network. PMID: 14764870.

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The Pharma Data

APRIL 28, 2021

OSAKA, Japan, April 28, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories. About Takeda Pharmaceutical Company Limited.

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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. And despite numerous high-profile, individual success stories in U.S. 4 But the same barriers still exist today.

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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The Pharma Data

AUGUST 19, 2021

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

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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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Sygnature Discovery

AUGUST 20, 2024

Jade Dagher – General Manager, Canada Jade is a “big hitter” in the sector and has over 35 years of experience in pharmaceuticals, including 25 years with Global pharma giant Merck. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 25 clinical compounds, with its scientists named on over 170 patents.

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Agency IQ

JUNE 21, 2024

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation.

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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. But despite the law’s age, it is not yet fully operational.

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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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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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Common Sense for Drug Policy Blog

NOVEMBER 15, 2023

Based on this premise, the first Canadian small-scale safer supply programs began operating in Ontario from 2017 onward, initially providing prescribed pharmaceutical-grade hydromorphone to small numbers of at-risk drug consumers. 2020 ; Tyndall, 2020 ).

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Agency IQ

SEPTEMBER 29, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. 2020) (LEAN). The residual risk and technology review (RTR) was promulgated pursuant to CAA 112(f) and 112(d)(6) on July 24, 2020.

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Pseudo/ephedrine detections peaked in 2004 (17 %) but practically disappeared after 2006, when the federal ban on over-the-counter pseudoephedrine sales took effect ( Rigdon, 2012 ). Pharmaceuticals (5 %) and supplements (4 %) appeared consistently as adulterants, but their prevalence has generally declined over time. 2024.112467.

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Agency IQ

JUNE 16, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2020) (LEAN).

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New Drug Approvals

APRIL 5, 2025

15] In February 2004, orphan designation (EU/3/04/186) was granted by the European Commission to medac Gesellschaft fuer klinische Spezialprparate mbH, Germany, for treosulfan for the conditioning treatment prior to haematopoietic progenitor cell transplantation. [16] 155 and Organic.Syntheses, (2004), Coll.Vol.10, 21 December 2022.

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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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Agency IQ

DECEMBER 15, 2023

The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2004) and related cases. The Lime Manufacturing NESHAP was promulgated pursuant to section 112(d) of the CAA on January 5, 2004. The current MPP ELGs also do not limit nutrient discharges from all regulated facilities.

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Agency IQ

JANUARY 4, 2024

2004) and related cases. The Lime Manufacturing NESHAP was promulgated pursuant to section 112(d) of the CAA on January 5, 2004. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. Circuit’s decisions in Northeast Maryland Waste Disposal Facility v.

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Codon

FEBRUARY 23, 2025

million by 2004. In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. Pharmaceutical companies generally charge high rates for patented drugs to recoup their huge investments into research, development, trials, and marketing.

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Drug & Device Law

MARCH 4, 2024

2004), held that “plaintiffs had a full and fair opportunity to develop and defend their choice of experts. Allied Erecting & Dismantling Co. United States Steel Corp. 2023 WL 5322213, at *6 (6th Cir. Likewise, Lippe v. Bairnco Corp. , 274 (2d Cir. 49, 55 (2005). In Rimbert v. Eli Lilly & Co. 2009 WL 10672150 (D.N.M.

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Drug & Device Law

JANUARY 15, 2024

2004) (pre- Tincher product liability case; “assessment of the dangers of unfair prejudice and confusion of the issues are procedural matters that govern in a federal court notwithstanding a state policy to the contrary”); Kelly v. Janssen Pharmaceuticals, Inc. , at 354 (citations omitted). Blaw-Knox , 360 F.3d 3d 426, 431 n.3

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