2019, Packaging, Pharmaceuticals and Regulations

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

The commission is proposing the introduction of temporary emergency marketing authorisations 1. Extra foreign inspections Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

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. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

Packaging

Packaging Regulations Laboratories Animal Testing

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Agency IQ

NOVEMBER 3, 2023

Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. See AgencyIQ’s analysis of the proposed regulation.] wide level.

Regulations

Regulations International Pharmaceuticals Production

Transcending expectations for cell & gene therapy development

Drug Discovery World

JULY 11, 2022

As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. For regulatory purposes, they may be treated more like a pharmaceutical or a blood product. 2019,January 15). A quality system that is set up to handle both is required. Molecular therapy.

Therapies

Therapies Clinical Trials Production Trials

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. points of disruption).

Regulations

Regulations Packaging Production FDA

Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

The Pharma Data

MARCH 25, 2021

Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. About Dengue.

Vaccine

Vaccine Virus Trials Hospitals

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

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

FDA

FDA Science Drugs Regulations

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

JANUARY 9, 2021

. Revenue Metrics Total revenues for 2020 are expected to be in the range of $1,545 and $1,555 million, an increase at the midpoint of $444 million or 40% as compared to 2019. 2019 (Actual). 2019 (Actual). 2019 (Actual). FOOTNOTES.

Government

Government Vaccine Production Licensing

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

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations

Regulations FDA Science Production

Deliberate Dysentery

Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. And if I'm a pharmaceutical company, I don't get any profit out of designing a model to test a vaccine or medicine.

Vaccine

Vaccine Trials Disease Virus

Extraordinary General Meeting in Oncopeptides AB (publ) – Nov 03, 2020

The Pharma Data

NOVEMBER 2, 2020

US Co-worker LTIP 2020 is intended for employees in Oncopeptides in the US hired or to be hired within the buildup of the US operation during 2019 and earlier, 2020 and 2021. All persons hired in the US business during 2019 and earlier, 2020 and 2021, excluding all members of the global senior management, can be granted Share Awards.

Marketing

Marketing Regulations Packaging Pharmaceutical Companies

Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

Agency IQ

NOVEMBER 27, 2023

In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug. By early 2019, it became apparent that NDMA was not the only nitrosamine forming in API synthesis. By early 2019, it became apparent that NDMA was not the only nitrosamine forming in API synthesis. guidelines.

Regulations

Regulations Production FDA Packaging

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science

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Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

AUGUST 6, 2020

Otezla® Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. All comparisons are made versus the same period in 2019 unless otherwise stated. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019. Second Quarter. . .

Production

Production International Licensing Licensing

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

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations

Regulations Compliance Production Government

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

FDA

FDA Science Production Regulations

Overcoming inefficiencies to improve access to cell and gene therapy

Drug Discovery World

MARCH 13, 2023

Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed. Jude Children’s Research Hospital where she researched mechanisms of immune regulation. McKinsey &Company Pharmaceuticals & Medical Products Practice.

Therapies

Therapies Drug Development Clinical Trials Cell Based Assays

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

But while the plan may be approved, the decision by FDA still leaves open plenty of questions – and the potential that pharmaceutical trade groups may sue to halt the implementation of the plan. Then, in December 2019, the FDA issued two proposed pathways to allow for drug importation, which were finalized in September 2020.

FDA Approval

FDA Approval FDA Science Drugs

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. TITUSVILLE, N.J. , cp-51575v4.

FDA Approval

FDA Approval Treatment RNA FDA

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

Beyond Steel Tanks

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering

Engineering Vaccine Production RNA

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

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations

Regulations Compliance Production Science

The Book of Nimbus

LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g., It was January 3 rd , 2019, and BMS just announced that they were acquiring Celgene.

Small Molecule

Small Molecule Computational Chemistry Engineering Clinical Development

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

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Compliance Government Science

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Paper by Sha G.

DNA

DNA Therapies Engineering Clinical Trials

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Paper by Sha G.

DNA

DNA Therapies Engineering Clinical Trials

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations

Regulations FDA Science Production

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

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2019 WL 4751807, at *8 (D. 30, 2019) (“a patent application is not a tangible good. . . Medicis Pharmaceutical Corp. , 2019), precluded assertion of strict liability in litigation over a bank loan.

Production

Production International Trials Government

Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

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

Trending Sources

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Transcending expectations for cell & gene therapy development

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

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

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

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

Deliberate Dysentery

Extraordinary General Meeting in Oncopeptides AB (publ) – Nov 03, 2020

Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

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

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

Overcoming inefficiencies to improve access to cell and gene therapy

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Beyond Steel Tanks

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

The Book of Nimbus

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

Codon Digest: Hackathon Prize Winners

Codon Digest: Hackathon Prize Winners

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

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

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