The Pharma Data

JUNE 17, 2022

As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL 2 and Hyrimoz HCF. 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

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The Open Targets Blog

JUNE 21, 2022

A brief history of our Front-end ecosystem We launched the Open Targets Platform at the end of 2015. The use of OT-UI was complicated by issues such as handling third-party library versions, developing in a local environment using NPM (node package manager), and integrating custom components.

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Advarra

JULY 19, 2022

Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date. of this guidance.

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Packaging FDA Trials Regulations 52

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. Trends in Cannabis Use Among Older Adults in the United States, 2015-2018. Adolescents exposed to cannabis marketing have greater odds of using the drug. 2020; 66(2):247-254.

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Dark Matter Blog

APRIL 4, 2023

Prior to 2015, I had a casual relationship, at best, with targeting RNA. Targeting RNA is a Whole New World Then in 2015, I became smitten and eloped with RNA, setting out to build a company devoted to bringing to bear industrial drug discovery concepts and methods on a new problem of drugging RNA with small molecules.

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

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Biosimilars Pharmacokinetics FDA Approval Packaging 40

The Pharma Data

NOVEMBER 18, 2021

Gilead’s option, on a program-by- program base, expires after a specified period of time following the achievement of a development corner for similar program and Arcus’s delivery to Gilead of the needful qualifying data package.

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Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Medical gases were one of several topics during the deliberations that led up to the passage of the final legislative package, which was known as the Food and Drug Administration Safety and Innovation Act (or FDASIA).

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Agency IQ

DECEMBER 15, 2023

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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Agency IQ

JANUARY 19, 2024

This approval type has always been uncommon – before the pandemic, this pathway was used just eight times between 2015 and 2019. [ See AgencyIQ’s analysis of this approval type from 2015-2021 here.] The clinical package, safety and label were not affected. Four drugs that were recommended for approval in the E.U.

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Agency IQ

JANUARY 26, 2024

In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. For example, the stability of the oral anticoagulant Pradaxa (dabigatran; Boehringer Ingelheim) is compromised once the original packaging is opened due to concerns related to moisture.

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Science FDA Production Packaging 40

Agency IQ

AUGUST 18, 2023

Its 2015 classification of popular herbicide glyphosate as a carcinogen 2A was notable, though both the EPA and the European Chemicals Agency (ECHA) have since declined designating glyphosate as a carcinogen. [ The IARC is also not against being the sole body to designate certain substances as carcinogens. European Union The E.U.

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Agency IQ

JUNE 17, 2024

However, in September 2015, the Federal Council – the Swiss executive – decided in consultation with stakeholders to pursue chemical regulatory policy independently of any formal cooperation with Brussels. Switzerland’s regulation of industrial chemicals, for the most part, follows that of the EU.

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Agency IQ

AUGUST 4, 2023

With respect to product verification, companies were required to have systems in place to verify “whether the product identifier affixed to, or imprinted upon, a package … corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager.”

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Codon

APRIL 23, 2024

Scientists announced evidence of liquid water on Mars in 2015, but it's important to consider the state of that water; cold brines that are kept in a liquid state by extremely high concentrations of salt. The entire planet is basically a desiccant, akin to those white packets found in packages of beef jerky that say “Do not eat.”

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Engineering DNA Hospitals International 81

Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. In 2015, the FDA revoked the GRAS status for PHOs.

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The Pharma Data

JUNE 18, 2021

The global burden of IBD: from 2015 to 2025. 2015 Dec;12(12):720-7. SYRIZI (risankizumab) [Package Insert]. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. Nat Rev Gastroenterol Hepatol. doi: 10.1038/nrgastro.2015.150. AbbVie Inc.

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Codon

MAY 30, 2023

This means that IscB base editors might be easier to package inside of AAVs, which can only store 4,700 bases of DNA for gene therapies. Malaria deaths plummeted between 2010 and 2015, thanks mostly to the billions of dollars in philanthropic funding that were used to purchase bed nets and medicines. This paper is a big deal!

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DNA RNA Engineering Vaccine 52

Codon

MAY 30, 2023

This means that IscB base editors might be easier to package inside of AAVs, which can only store 4,700 bases of DNA for gene therapies. Malaria deaths plummeted between 2010 and 2015, thanks mostly to the billions of dollars in philanthropic funding that were used to purchase bed nets and medicines. This paper is a big deal!

DNA 52

DNA RNA Engineering Vaccine 52

The Pharma Data

JUNE 18, 2021

The global burden of IBD: from 2015 to 2025. 2015 Dec;12(12):720-7. SKYRIZI (risankizumab) [Package Insert]. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov.

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Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits.

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Regulations FDA Science Production 40

Agency IQ

APRIL 8, 2024

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

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LifeSciVC

APRIL 27, 2023

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. For further reading about Nimbus’ first chapter, many an excellent blog has been written about those formative days.

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Small Molecule Computational Chemistry Engineering Clinical Development 40

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. And it really is the entire package that has been formed. … Last week, the FDA and AACR co-hosted a two-day workshop on the topic of optimizing dose-finding in oncology drug development. A lot of times the lower dose wins, right?

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Science FDA Trials Clinical Pharmacology 40

Practical Cheminformatics

JANUARY 3, 2023

However, after the Kaggle Merck Molecular Activity Challenge 2013 and the Tox21 Data Challenge 2015 , DNNs have emerged as the method of choice for QSAR applications in drug discovery.” A new package, Auto3D, from the Isayev group at Carnegie Mellon, could change this situation by making learned quantum chemical potentials very easy to use.

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Drugs Science Packaging Production 40

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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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.

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The Pharma Data

MAY 13, 2021

In a 2015 study published in the Journal of Traditional and Complementary Medicine…. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Once you’ve selected your package…. When it comes to supporting healthy insulin levels.

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Production Packaging Doctors Research 52

Agency IQ

MARCH 29, 2024

EPA previously revised the Steam Electric ELGs in 2015 and 2020. The 2015 limitations for combustion residual leachate and legacy wastewater discharged by existing sources were vacated by the U.S. The first two waste streams mentioned above are the subject of current litigation pending in the U.S. Appalachian Voices, et al.

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Agency IQ

JUNE 16, 2023

Proposed Rule Stage Revisions to the Air Emission Reporting Requirements (AERR) 2060-AV41 August 2023 This action proposes revisions to the existing Air Emissions Reporting Requirements (AERR) rule last revised on February 19, 2015 (80 FR 8787).

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Agency IQ

DECEMBER 1, 2023

This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. Since promulgation, advancements have been made in leak detection technologies that warrant review of the alternative work practice.

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Regulations Production Compliance Science 40

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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The Pharma Data

OCTOBER 14, 2020

“Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries.

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Agency IQ

FEBRUARY 2, 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.

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Regulations Compliance Engineering Government 40

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.

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Regulations Compliance Government Science 40

Agency IQ

JULY 28, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 But despite the law’s age, it is not yet fully operational.

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Drug & Device Law

DECEMBER 29, 2023

Also of interest is Acetaminophen ’s discussion of the FDA’s five reviews of the purported “risk” between 2015 and 2023, all of which ended the same way: that due to “limitations and inconsistent findings,” the science was “unable to support a determination of causality.”

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