addgene Blog

OCTOBER 3, 2024

This includes the first Addgene prep packaged in the AAV9-X1.1 If the fall colors are inspiring you to paint your cells in equally vivid colors, you'll want to check out the 34 new preps available in the Addgene viral vector repository! serotype.

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Packaging 129

PPD

NOVEMBER 11, 2024

According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8 From an aging population increasing health care demand to urgent, unmet medical needs, there are clear drivers to advance safe and effective medicines to patients faster than ever. billion in 2035.

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Broad Institute

MARCH 19, 2024

Researchers roll out a more accurate way to estimate genetic risks of disease By Claire Hendershot March 19, 2024 Breadcrumb Home Researchers roll out a more accurate way to estimate genetic risks of disease Two new approaches for generating polygenic scores demonstrate that compiled data improves score accuracy. Online March 19, 2024.

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Perficient: Drug Development

MAY 9, 2024

Continue reading below for a summary of what we’ve done in 2024 thus far! Restoring One’s Hope – Feed the Hungry On March 9th 2024, Atlanta colleagues volunteered with Restoring One’s Hope Atlanta for their Feed the Hungry program to prep and package full meals and hygiene kits for the unhoused population in Atlanta.

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Packaging 52

Broad Institute

JANUARY 8, 2024

Williams January 8, 2024 Credit: Susanna Hamilton, Broad Communications Researchers have developed virus-like particles that can deliver gene-editing cargo to cells, including those in the mouse brain. Online January 8, 2024. By Sarah C.P. Paper cited: An, M. Nature Biotechnology.

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Broad Institute

JULY 10, 2024

Next, researchers will need to develop ways to package and deliver the prime editing machinery to the airways in mice and ultimately humans. Online July 10, 2024. The new approach also generated 3.5 times fewer unwanted insertions and deletions per edit than previous methods that use the Cas9 nuclease enzyme.

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Engineering Packaging DNA Treatment 145

Broad Institute

MAY 16, 2024

By Allessandra DiCorato May 16, 2024 Credit: Deverman lab Brain vasculature (in blue) surrounded by RNA (in orange) transcribed from the gene delivered to the brain in humanized mice using an engineered AAV targeting the human transferrin receptor. Online May 16, 2024. Paper cited Huang Q, Chan KY, et al. DOI: 10.1126/science.adm8386.

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Fierce BioTech

OCTOBER 8, 2024

Ana Kuschel Francis Carroll Sonia Adamidis Marc Uerdingen Duration 90 Minutes Join West experts to learn about solutions for today’s drug products and tomorrow’s novel applications and gain insights to understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery. Click here to login.

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Packaging Drugs Production 52

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

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Clinical Trials Trials Science FDA 52

Broad Institute

AUGUST 7, 2024

Machine learning approach helps researchers design better gene-delivery vehicles for gene therapy By Allessandra DiCorato August 7, 2024 Breadcrumb Home Machine learning approach helps researchers design better gene-delivery vehicles for gene therapy The method could accelerate the development of more effective adeno-associated viruses (AAVs).

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Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Name CAS RN Hazard endpoint proposed for vertebrate testing Deadline 10 testing proposals for seven chemical entries, including for dibromomethane, diethyl succinate, and triisobutyl phosphate.

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Broad Institute

JUNE 27, 2024

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We’re about to find out.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. This edition reviews developments that occurred in late 2023 and early 2024.

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FDA Law Blog: Biosimilars

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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FDA Packaging Production Drugs 52

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Alta Sciences

APRIL 6, 2024

Strategies for Safe and Timely Shipments blussier Sat, 04/06/2024 - 23:35 HTML Your Samples Are in Good Hands With Us! From regulatory precision to preserving sample integrity, shipments can be challenging.

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Packaging Compliance 52

Broad Institute

FEBRUARY 21, 2024

By Claire Hendershot February 21, 2024 Credit: Allison Colorado, Broad Communications Khalid Shakir is a principal software engineer in the McCarroll Lab. I’ll say I’m excited about interactive visualizations, which are built on top of open source plotting packages such as R.

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Fierce BioTech

MAY 2, 2024

In this webinar, you will learn about: The challenges and risks related to the packaging and filling of high-value drug products. On Demand Start Date Wed, 06/12/2024 - 12:00 Listing Image WEST_ListingLogo_250x190.png

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Biosimilars 40

Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. These address classification and labeling harmonization (CLH) of dazomet (ISO) and occupational exposure limit (OEL) values for N-(hydroxymethyl)acrylamide, anthraquinone, butanone oxime, and acetone oxime.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Under REACH, these address testing proposals for five entries, including trimethylolpropane diallyl ether and 5-(hydroxymethyl)-2-furaldehyde.

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Cannabis products are often sold in colorful packages that mimic kid-friendly snack foods, for example, making them appealing to children and to young people. Published July 8, 2024. Published January 2, 2024. Published 2024. Accessed September 26, 2024. The Lancet. 2023;401(10383):1194-1213. doi: [link] CDC.

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FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024. By Deborah L.

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Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

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Drugs Packaging Compliance Drug Development 52

Agency IQ

MARCH 15, 2024

BY WALKER LIVINGSTON, ESQ | MAR 13, 2024 2:33 PM CDT Background: CalRecycle and plastic waste regulations in California The California Department of Resources Recycling and Recovery (CalRecycle) oversees the state’s initiatives towards reducing waste and reusing materials. That amount will increase to 40% in 2030 and 65% in 2032.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA is receiving comments until the end of March on one substance being considered for exemption. The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment.

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Regulations Production Packaging Science 40

FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

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Agency IQ

MAY 10, 2024

BY WALKER LIVINGSTON, ESQ | MAY 7, 2024 10:50 PM CDT Background: PFAS Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

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Molecular Design

DECEMBER 31, 2023

Matches with PAINS substructures would not rule out the use of a compound as a tool if the appropriate package of measured data is available. In contrast, a compound that does not match any PAINS substructures cannot be regarded as an acceptable tool if the appropriate package of measured data is not available.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. July 31, 2024. [ii] 89 FR 61474.

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Alta Sciences

NOVEMBER 5, 2024

Their advantages include ease of scalability and manufacturing, ease of packaging, and high product stability. This blog was originally posted 07/26/2021 and updated on 11/05/2024 Reference [link] Image Thumbnail_Blog-LFHSCs-alt.jpg Synopsis Liquid-filled capsules can be rapidly developed and tested, moving quickly from R&D to clinic.

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Agency IQ

JULY 12, 2024

BY WALKER LIVINGSTON, ESQ | JUL 11, 2024 6:28 PM CDT Background: PFAS and TSCA Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been in use since the 1940s. On April 18, 2024, the EPA announced receipt of the petition and stated that the agency would grant or deny the petitions by July 10, 2024.

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