Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. Stakeholders now have until March 8 to provide feedback on the proposal. BY SCOTT STEPHENS, MPA | FEB 12, 2024 10:42 PM CST Bisphenol A (CAS No.

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The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Starting in 2016, many versions were developed through internal collaboration and change requests until, in 2022, eCTD v4.0

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Perficient: Drug Development

AUGUST 29, 2023

Sitecore recently announced they are moving away from MyGet and to NPMJS for its package provider. This change will affect three existing packages with the new prefix. Remove the NPM configuration that points to the MyGet registry Uninstall/reinstall Sitecore’s SXA CLI tool Update four files in the theme from the package repository 1.

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FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

While much of the effect may have been on the internal processes of the review division and other disciplines tasked with evaluating the approvability of applications submitted to CDER, a significant change also occurred in how CDER conveys information about the internal review process and conclusions that lead to an application approval.

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Perficient: Drug Development

FEBRUARY 29, 2024

Reverse Engineering the Existing SPA Editor The front-end portion of the SPA Editor is composed of five NPM packages. Of these five packages, three were specific to React or Angular. These are the three packages I would need to reverse engineer and replicate in Vue. of @adobe/aem-react-editable-components, version 1.1.8

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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The Pharma Data

MAY 17, 2021

JAMA Intern Med Gyawali et al. JAMA Intern Med Gunter et al. . Posted 17 May 2021 | By Jeff Craven . Although the UDI was enacted with good intentions, the FDA was wise to end it,” Gunter and colleagues concluded. © 2021 Regulatory Affairs Professionals Society. Source link.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

The Adverse Event codes accepted in sections F10 and H6 of the 3500A form will be updated to harmonize with maintenance updates from the International Medical Device Regulators Forum (IMDRF). For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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PPD

MARCH 13, 2024

The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams. As a conduit, their role is to assess the timelines together, being the liaison with the manufacturing organization and implementing risk management and mitigation.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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The ChEMBL-og

JUNE 13, 2023

ChEMBL database version ChEMBL 33 release notes _ # This version of the database, prepared on 31/05/2023 contains: 2,399,743 compounds (of which 2,372,674 have mol files) 3,051,613 compound records (non-unique compounds) 20,334,684 activities 1,610,596 assays 15,398 targets 88,630 documents BioAssay Data Sources: Number Assays: Number Compound Records: (..)

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DrugBank

SEPTEMBER 12, 2024

Data Integration For those integrating DrugBank data into internal systems, the Data Dictionary serves as a critical reference for mapping fields to your database schema accurately. This speeds up the exploration process, enabling you to uncover new insights faster.

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Perficient: Drug Development

AUGUST 1, 2024

The retailer alerts the drop-shipping partner – either the manufacturer or the wholesaler – who packages and ships the product to the customer. With white label customization, DSV can personalize things like packaging. It reduces storage and picking fees, plus it eliminates the risk of having items on hand that just won’t sell.

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The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

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The Pharma Data

MARCH 15, 2022

Teva is donating medicines valued at over $11M, for acute therapies in support of Ukrainian refugees The donations include over 1 million packages of antibiotics and other essential medicines as well as hygienic products for Ukrainian infants and children. Teva Pharmaceutical Industries Ltd.

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The Pharma Data

OCTOBER 27, 2020

or Canada , or 847-413-3238 from international locations, passcode 49992942. Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. Eastern Time to review the company’s performance and answer questions.

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The Pharma Data

JUNE 7, 2023

The launch of the expanded offering will coincide with Catalent exhibiting at the BIO International Convention (booth 785), which takes place at the Boston Convention & Exhibition Center, from June 5-8, 2023. At the BIO International Convention, Carey Connolly, Ph.D., at the BioProcess International Theater.

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Perficient: Drug Development

DECEMBER 8, 2023

There was an issue that occurred after adding a package: the compiler errored out demanding to specify the exact version number of this package.

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Practical Cheminformatics

JANUARY 8, 2024

increase in AUC-PR over internal models. A Tutorial on Encoding and Generating Small Molecules with COATI [link] COATI: multi-modal contrastive pre-training for representing and traversing chemical space [link] The team at AstraZeneca released version 4 of their software package REINVENT for generative design.

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The Pharma Data

NOVEMBER 5, 2021

The final product assembly and packaging plant will support the growing demand for Amgen’s medicines in the United States and is expected to be operational by 2024. Amgen today announced the groundbreaking of its newest biomanufacturing plant, located in New Albany, Ohio.

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Agency IQ

FEBRUARY 12, 2024

Lack of international harmonization is a challenge for generic products. The International Council for Harmonization (ICH) has developed limited standards for generic drugs, such as the M13 guideline on bioequivalence for immediate-release solid oral dosage forms [ Read AgencyIQ’s detailed analysis of that document here here. ]

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The Pharma Data

JANUARY 5, 2021

Lattice Biologics develops and manufactures biologic products to domestic and international markets. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction. and internationally.

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The Pharma Data

JANUARY 31, 2021

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR ® technology and structure-based drug design platform capabilities. ” About Sosei Heptares. For more information, please visit www.metrionbiosciences.com.

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Perficient: Drug Development

JULY 25, 2023

xConnect apps are usually set up inside a private network as no public access is required and they can communicate with each other internally as long as they are set up inside the same private network. This involved comparing files that are included in the WDP package for Azure and Solr and disabling/enabling them.

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The Pharma Data

NOVEMBER 22, 2020

Debra Kristensen, who has worked in vaccine innovation and supply chains at PATH, an international public health nonprofit, for thirty years, told NPR , “I believe it can be done. Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers.

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Agency IQ

FEBRUARY 23, 2024

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. 2030 is a short timeframe for compliance in supply chains.

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Agency IQ

JULY 26, 2024

It also implements EU commitments to the Rotterdam Convention on the prior informed consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade. Chemical CAS RN (or EC No.)

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The Pharma Data

NOVEMBER 30, 2020

Strong participation from international syndicate of investors, including Gilde Healthcare, Invus and BioMed Partners. The global consortium of new international investors includes Gilde Healthcare, Invus and BioMed Partners. . Highly experienced team leverages latest scientific discoveries in neuroscience.

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Translation

JULY 9, 2024

Kevin Leland: Do you find that these tech landscapes are any materially different whether you’re talking about packaging, gene therapy, or women’s health, for example, or do they all follow the same format? You could have two packaging companies that have completely different outputs based on the way they work internally.

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Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

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Agency IQ

JULY 12, 2024

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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LifeSciVC

AUGUST 21, 2024

As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate. I can tell you that CDMO summer shutdowns are a real thing.

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Perficient: Drug Development

MAY 8, 2024

This compiler will handle re-rendering internally, eliminating the need for developers to explicitly implement useMemo , memo , and useCallback. Developers often relied on external packages like ‘react-helmet’ to manage this. Developers often use useMemo , memo , and useCallback to mitigate these issues manually.

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NIH Director's Blog: Drug Development

MARCH 11, 2014

In an unprecedented effort aimed at finding and validating new therapeutic targets for T2D, an international team led by NIH-funded researchers recently analyzed the DNA of about 150,000 people across five different ancestry groups. Recent studies also suggest that this protein is important in insulin-clearance in the liver [5].

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The Pharma Data

DECEMBER 8, 2020

RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages. SciNeuro Pharmaceuticals . Most read today on BioSpace: Source link.

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Agency IQ

NOVEMBER 27, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. regulators “will also continue to collaborate with international partners on Nitrosamine to reflect scientific advances.”

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Existing published VCS may be identified internally by FDA or externally by stakeholders. The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation.

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