Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 dwf_admin Tue, 10/29/2024 - 14:01 Source Russell E, Hawk M, Neale J, et al. Published online September 17, 2024.

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The Pharma Data

JUNE 24, 2025

Key Highlights from the 2024 Corporate Responsibility Report Baxter’s newly published report details progress toward its long-term sustainability and impact goals, focusing on measurable achievements made in 2024 across environmental sustainability, community engagement, product stewardship, and employee well-being.

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Perficient: Drug Development

JANUARY 14, 2025

Let me take you through the event that perfectly wrapped up 2024! Rajiv’s session focused on Docker, explaining how it allows developers to package, deploy, and run applications in isolated containers, ensuring consistency across different environments. We’re already excited about the next one!

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Drugs.com

SEPTEMBER 24, 2024

24, 2024 -- Food sold in shrink wrap, on cardboard trays or in paper containers might contain any of nearly 200 chemicals linked to breast cancer, a new study warns.Commonly used food packaging materials contain 189 chemicals that. TUESDAY, Sept.

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The Pharma Data

JULY 2, 2025

These grants, made in accordance with Nasdaq Listing Rule 5635(c)(4), were issued under Incyte’s 2024 Inducement Stock Incentive Plan and approved by the Compensation Committee of the Board of Directors. The design of Mr. Meury’s inducement package underscores Incyte’s emphasis on performance-driven leadership and shareholder alignment.

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Drugs.com

FEBRUARY 28, 2024

28, 2024 -- PFAS "forever" chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. WEDNESDAY, Feb. Food and Drug Administration announced Wednesday."Grease-proofing Grease-proofing materials.

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Drugs.com

SEPTEMBER 17, 2024

17, 2024 -- That plastic wrap you find around the food you eat is far from benign: A new study shows that more than 3,600 chemicals leach into food during the packaging process.Of TUESDAY, Sept. that number, 79 chemicals are known to cause cancer.

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Packaging 246

Drugs.com

FEBRUARY 1, 2024

1, 2024 -- Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday.The packaging for South Moon, Rebright and FivFivGo eyedrops. THURSDAY, Feb.

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Drugs.com

APRIL 16, 2024

TUESDAY, April 16, 2024 -- In the wake of a sharp rise in the number of young children accidentally eating melatonin supplements, an industry group has called for tougher safety guidelines for packaging and labeling the sleep-aid.

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Drugs.com

MARCH 12, 2024

TUESDAY, March 12, 2024 -- Be sure to check your fridge for any Johnsonville turkey kielbasa sausage -- over 35,000 pounds of the product is under recall due to some customers finding "pieces of rubber" in the packaged meat. Denmark, Wisc.-based.

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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 141

Drugs.com

FEBRUARY 12, 2024

12, 2024 -- Think twice if you're pregnant and craving a packaged pastry or a take-out burger and shake.That indulgence can do more than cause unwanted weight gain. MONDAY, Feb. A new study shows that phthalates, chemicals associated with plastics,

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Packaging 244

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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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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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

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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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. Analysis One wonders what role the envisioned ECHA basic regulation will have in supporting this reform package.

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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

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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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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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. BY SCOTT STEPHENS, MPA | FEB 12, 2024 10:42 PM CST Bisphenol A (CAS No. The substance has a harmonized classification entry (i.e.,

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FDA Law Blog: Biosimilars

JULY 10, 2025

These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

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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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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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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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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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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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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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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

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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The Premier Consulting Blog

APRIL 27, 2023

applications from any sponsors who choose to use it in Q1 of 2024, and by 2028, it will be required in the US for all sponsors. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 The agency will begin accepting eCTD v4.0

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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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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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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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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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