Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Biosimilars Packaging Labelling Drug Development 130

European Pharmaceutical Review

SEPTEMBER 2, 2022

Netherlands Medicines Evaluation Board (CBG-MEB) 2022 [cited June 2022]. US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. References.

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European Pharmaceutical Review

FEBRUARY 7, 2023

Regulation of clinical trials Eight years following its adoption in 2014, the Clinical Trials Regulation 536/2014 (CTR) entered into application on 31 January 2022. However, those proposals that are adopted could have wide-ranging impact.

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Packaging Drug Development 117

European Pharmaceutical Review

DECEMBER 21, 2022

10 Diagnostics and biologics also heavily utilise carbon-based materials as constituting building blocks, processing aids, single-use reactors, or packaging materials. He is currently group leader of the Technology Development and Discovery Group at the Bioprocess Laboratory of the ETH. Chem Rev 2022 122 (3), 3637‒3710.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The company focuses on small molecule, oral liquid, and solid dose products, providing formula development, method development, cleaning verification methods, tech transfer, pilot studies, commercial scale-up, and packaging. Avéma’s newest facility in Miami, which will come online in October 2022, will add 135,000 sq.

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Packaging Controlled Substances Documentation Pharmaceutical Companies 59

European Pharmaceutical Review

JANUARY 13, 2025

Research shows that the overall carbon emissions of the biotechnology sector globally totalled 193 million tCO2-e (tonnes of carbon dioxide equivalent) in 2022. Research shows that the overall carbon emissions of the biotechnology sector globally totalled 193 million tCO2-e (tonnes of carbon dioxide equivalent) in 2022. NHS England.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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PharmaShots

FEBRUARY 27, 2023

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. We can order drugs online and can have online consultations.

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Biosimilars Diabetes Packaging Hospitals 40

pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Chair for 2022: Gretchen Vandal, Sr. Featured 2022 Speakers Include: Joyce Zhao, Associate Director, Combination Product, Takeda. Who should Attend: Drug-delivery developers. Primary Packaging material designers. Drug developers.

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Packaging Documentation Vaccines Drug Development 52

STAT

OCTOBER 10, 2023

The state’s biotech scene   exploded in the mid-2010s and early in the pandemic as exuberant investors disregarded the high failure rate in drug development and bet on buzzy technologies such as gene editing and messenger RNA vaccines. But the   drumbeat of layoffs in 2022   has only grown louder this year.

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pharmaphorum

FEBRUARY 28, 2022

As part of SMi’s leading series of drug delivery device conferences, the 2022 event will provide insights into the rapidly accelerating market of combination product development with industry, device developer and regulatory perspectives. Amin Sedighiamiri, Associate Director, Device Development, AstraZeneca.

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Packaging Vaccines Drug Development 52

European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drug development. Significance of Annex 1–2022 for implementing Pharma 4.0 Yet in 2021, 100 nanomedicines had been marketed.

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Process Improvement Packaging Vaccines Drug Development 95

Putting Patients First Blog

SEPTEMBER 30, 2024

The goal of the rare pediatric disease PRV program is to incentivize drug development for rare pediatric diseases. The Act went into effect January 2022 and created billing requirements including cost-sharing rules and notice and consent requirements.

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Department of Veterans Affairs Packaging Drug Development 98

Express Pharma

AUGUST 20, 2023

In 2022, there were $37 billion in global sales of Pfizer’s Comirnaty and over $2 billion of J&J’s Jcovden. Even generics giant Teva Pharmaceuticals – a potential beneficiary of the reform – echoed the innovative drug developers’ preference for a voluntary licensing scheme.

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Packaging Vaccines Drug Development 98

European Pharmaceutical Review

DECEMBER 26, 2023

Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5 million hemophilia gene therapy is world’s most expensive drug [Internet]. Scientific American; 2022 [cited 2023 Jun]. 2022 [cited 2023 Jun].

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Drug Pricing Packaging Vaccines Drug Development 98

Pharmaceutical Technology

MARCH 22, 2023

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand.

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European Pharmaceutical Review

AUGUST 25, 2022

IN 2022, treating glioblastoma (GBM) remains an uphill battle. By packaging the oncolytic virus into stem cells, like a trojan horse, the cells protect the virus from the immune system until they arrive at the tumour site. The remaining missing piece of the puzzle has been how to shield them from destruction by the immune system.

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European Pharmaceutical Review

FEBRUARY 23, 2023

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

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Labelling Packaging Drug Development 121

Pharmaceutical Technology

DECEMBER 9, 2022

Rankings 2022. M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Solvias is well equipped to provide stability testing for all stages of drug development.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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