Agency IQ

SEPTEMBER 29, 2023

GDPR) and “is without prejudice” to the laws on protection of intellectual property (2001/29/EC, 2004/48/EC and (EU) 2019/790). The proposed law is subsidiary to Union and national laws on the protection of personal data, privacy and confidentiality (e.g., app interfaces) automatically and through bulk download where technically feasible.

Regulations 40

Regulations Government Production International 40

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. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries.

Therapies 137

Therapies Virus DNA Clinical Trials 137

The Pharma Data

AUGUST 1, 2021

Financial considerations AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

Trials 52

Trials Therapies Disease Treatment 52

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. Some of the affected former NDAs were approved using drug master files (DMFs).

FDA 40

FDA Science Biosimilars Regulations 40

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.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

JANUARY 13, 2021

11):1583 (2004) 6 Karpusas M, et al. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

Codon

JANUARY 2, 2024

In 2004, Gilson filed a lawsuit against Rainin, accusing Rainin executives of “a campaign to disparage Gilson's Pipetman products and route customers to their own competing product lines.” The German company that first licensed Schnitger’s 1957 invention, Eppendorf, also made the first disposable polypropylene tips.

Laboratories 130

Laboratories DNA Licensing Licensing 130

The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

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.

Clinical Trials 52

Clinical Trials Virus Trials FDA 52

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

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. 2020) (LEAN).

Regulations 40

Regulations Compliance Production Science 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Current Genetics (2017). Science (2021).

DNA 98

DNA Cell Biology Molecular Biology Engineering 98

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. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Science (2021).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

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. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. However, licensed software can be a UCC sale of “goods.”

Production 52

Production Trials International Government 52

Drug & Device Law

FEBRUARY 2, 2023

2004); and Hackett v. 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. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir.

Production 59

Production FDA Approval Vaccine FDA 59

New Drug Approvals

APRIL 27, 2025

6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] billion in 2004. [23] billion in 2004. [23] billion in 2004.

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

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, to 105 C (214.7

FDA 62

FDA FDA Approval Production Treatment 62

BMG Labtech

FEBRUARY 24, 2025

2004 Mar 23;101(12):4003-8. Epub 2004 Mar 12. 3 in this blog adapted from this reference under license CC-BY 4.0. 4 in this blog adapted from this reference under license CC-BY 4.0. 5 in this blog adapted from this reference under license CC-BY 4.0. Proteomics. 2015 Jan;15(2-3):185-7. doi: 10.1002/pmic.201400592.

Small Molecule 52

Small Molecule Disease Licensing Licensing 52

Codon

FEBRUARY 23, 2025

million by 2004. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative. For more than two decades, the U.S. This has happened before with other drugs.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80