2009, Packaging and Pharmaceuticals - Drug Discovery Digest

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging

Packaging Regulations Laboratories Animal Testing

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

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. has a strong voice in the world. citizens; 2.

Pharmaceuticals

Pharmaceuticals Regulations Packaging Marketing

Getting Inside the Mind of the Medicinal Chemist with Machine Learning

Practical Cheminformatics

APRIL 3, 2023

In this case, I used the BMS filters from the rd_filters package. I then used the useful_rdkit_utils package to identify analogs with ring systems that do not occur in the ChEMBL database. An elegant approach to this question is the synthetic accessibility (SA) score published in 2009 by Peter Ertl and Ansgar Schuffenhauer.

Packaging

Packaging Drugs Marketing Pharmaceuticals

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

FDA

FDA Science Drugs Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations

Regulations FDA Science Production

The Book of Nimbus

LifeSciVC

APRIL 27, 2023

Chapter 1 – An Unreasonable Idea The year was 2009. Our small team was able to support multiple major pharmaceutical companies plowing through diligence, not just withstanding the onslaught but in fact delivering a data package of Phase 3-ready quality. Barack Obama had just been sworn in as the 44 th president.

Small Molecule

Small Molecule Computational Chemistry Engineering Clinical Development

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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.

FDA

FDA Science Biosimilars Regulations

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

The AWIA, section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

Regulations

Regulations Compliance Production Science

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

DECEMBER 15, 2023

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. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

Regulations

Regulations Compliance Production Government

Analysis Chemical Thank You What we expect the EPA to do in January 2024

Agency IQ

JANUARY 4, 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. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

Regulations

Regulations Government Compliance Science

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

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 developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted.

Clinical Trials

Clinical Trials Virus Vaccine Trials

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. 2009); see also Data Processing Services, Inc. 2009), aff’d in part & rev’d in part on irrelevant grounds , 659 F.3d 2d 968, 972 (Ariz.

Production

Production Trials International Government

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , Novartis Pharmaceuticals Corp. , at 1150 (citations omitted). Mason , 27 So.3d

Testimonials

Testimonials Production Pharmaceuticals Drugs

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. Janssen Pharmaceuticals, Inc. Wyeth Pharmaceuticals, Inc. Ortho-McNeil Pharmaceutical, Inc. See Allain v.

Testimonials

Testimonials Doctors Production Laboratories

Drug Discovery Digest

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Webinars

Trending Sources

Getting Inside the Mind of the Medicinal Chemist with Machine Learning

Webinars

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

The Book of Nimbus

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Chemical Thank You What we expect the EPA to do in January 2024

Making a “Miracle” HIV Medicine

How the Fifty States View Electronic Data as a “Product”

Confident Learned Intermediaries Defeat Warning Causation

Unimpressed Learned Intermediaries Defeat Warning Causation

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