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.

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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 40

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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.

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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 40

Marketing Regulations Packaging Pharmaceutical Companies 40

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 123

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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 40

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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 40

Science FDA Packaging Production 40

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 52

Production International Licensing Licensing 52

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 40

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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 40

FDA Science Production Regulations 40

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.

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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.

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Vaccine Pharmaceuticals Small Molecule Virus 40

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 40

FDA Science Regulations Production 40

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 40

FDA Science Regulations Production 40

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.

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FDA Approval FDA Science Drugs 40

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.

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FDA Approval Treatment RNA FDA 52

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 87

Engineering Vaccine Production RNA 87

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 40

Regulations Compliance Production Science 40

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.

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Regulations FDA Science Production 40

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 52

Small Molecule Computational Chemistry Engineering Clinical Development 52

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 40

Regulations Compliance Government Science 40

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 52

DNA Therapies Engineering Clinical Trials 52

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 52

DNA Therapies Engineering Clinical Trials 52

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.

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Regulations FDA Science Production 40

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.

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