Pharmaceutical Technology

DECEMBER 8, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan.

Licensing 305

Licensing Licensing Gene Therapy Gene 305

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. The discussion paper starts with an acknowledgment of the benefits of 3D printing at the point of care.

Manufacturing 98

Manufacturing Regulation Compliance Production 98

Rethinking Clinical Trials

AUGUST 3, 2023

If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety. One step journals can take is checking to see if cited papers have been retracted. AI generated work has been submitted to journals and other publications. How will it be framed in the public discourse?

Medicine 130

Medicine Research Vaccination Vaccine 130

Advarra

AUGUST 1, 2023

Typically used for investigator-initiated trials (IITs), EDC is used for transcribing paper source into an application, with a team providing downstream analysis for endpoint adjudication and data submission. In IITs especially, EDC users are responsible for submitting their own data. Additionally, eSource helps with analyzing data.

Compliance 52

Compliance Clinical Research Research Trials 52

Pharmaceutical Technology

JANUARY 17, 2023

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Development 276

Development Gene Therapy Antibody Gene 276

Pharmaceutical Technology

DECEMBER 18, 2022

The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. The EMA positive opinion is based on clinical findings of mRNA.1273.214, 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company.

Gene Therapy 304

Gene Therapy Vaccination Vaccine Clinical Trials 304

Pharmaceutical Technology

MARCH 20, 2023

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The partnership will focus on developing potential new vaccines to treat certain selected autoimmune indications, as well as food allergies.

Vaccination 245

Vaccination Vaccine Development Allergies 245

Pharmaceutical Technology

MARCH 28, 2023

Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D). The gene-editing technology allows for precise, directed changes to genomic DNA. The system comprises the Cas9 enzyme and a guide RNA.

Gene Editing 235

Gene Editing DNA Gene Gene Therapy 235

Pharmaceutical Technology

MARCH 8, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. Topic sponsors are not involved in the creation of editorial content.

Gene Therapy 244

Gene Therapy Manufacturing Gene Production 244

Pharmaceutical Technology

FEBRUARY 16, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development.

Development 242

Development Gene Therapy Gene Drugs 242

Pharmaceutical Technology

DECEMBER 5, 2022

Sanofi has signed an agreement with the Queensland Government in Australia to establish a $190m (A$280m) research facility in Brisbane. With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub. Free Whitepaper. By Cytiva Thematic.

Research 246

Research Gene Therapy Vaccination Vaccine 246

Worldwide Clinical Trials

MARCH 7, 2024

Once the CTA is submitted, the EU requires a new CTA for any new protocols amended. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”. The two regulatory frameworks offer distinct benefits and disadvantages, but which one is right for your drug development program?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

JANUARY 5, 2023

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. According to the deal, Capsida will get $55m, comprising an upfront payment and a commitment to participate in its next funding round.

Gene Therapy 237

Gene Therapy Gene Development Engineer 237

Pharmaceutical Technology

NOVEMBER 29, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. The takeover will offer AstraZeneca access to TCR-Ts, which possess the potential for fighting solid tumours. Free Whitepaper.

Gene Therapy 279

Gene Therapy Gene Development Manufacturing 279

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. The discussion paper starts with an acknowledgment of the benefits of 3D printing at the point of care.

Manufacturing 75

Manufacturing Regulation Compliance Production 75

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. Personalised medicines will also be developed at the centre. Topic sponsors are not involved in the creation of editorial content.

Gene Therapy 264

Gene Therapy Manufacturing Gene Clinical Trials 264

Pharmaceutical Technology

DECEMBER 12, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Development 264

Development Gene Therapy Clinical Trials Clinical Trials 264

Pharmaceutical Technology

FEBRUARY 9, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics.

Development 241

Development RNA Gene Therapy Genetics 241

FDA Law Blog

AUGUST 30, 2021

By Philip Won — On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. In this discussion paper , FDA emphasizes cybersecurity challenges related to a non-OEM (original equipment manufacturer) entity’s activities in the following four areas.

Production 52

Production Manufacturing 52

Drug Discovery World

JULY 20, 2023

The EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. AI/ML tools can also support data recording and analyses which will in turn be submitted to regulators in marketing-authorisation procedures.

Drugs 40

Drugs Regulation Medicine Big Data 40

Pharmaceutical Technology

MARCH 30, 2023

The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms. Moreover, the agency encouraged sponsors to submit applications for approval of OTC naloxone products. This approval comes at a time when the US is facing a growing opioid crisis.

Manufacturing 130

Manufacturing Packaging Packaging Production 130

Pharmaceutical Technology

JANUARY 27, 2023

The chimeric antigen receptor T-cell (CAR-T) therapy axicabtagene ciloleucel has been recommended for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients who have previously received two or more lines of systemic therapy.

Gene Therapy 147

Gene Therapy Clinical Trials Clinical Trials Gene 147

Pharmaceutical Technology

FEBRUARY 23, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies.

Gene Editing 147

Gene Editing Gene In-Vivo Gene Therapy 147

Pharmaceutical Technology

MARCH 27, 2023

Technology-focused biomanufacturing company National Resilience has signed a $410m long-term loan financing deal to establish a resilient end-to-end biomanufacturing capacity. The company received approval for the loan financing from the US Department of Defense (DoD) in partnership with the US International Development Finance Corporation (DFC).

Gene Therapy 130

Gene Therapy Manufacturing Vaccination Vaccine 130

Pharmaceutical Technology

MARCH 23, 2023

With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country. The latest authorisation from the Chinese health authority comes as cases of Covid-19 decline after a recent surge. efficacy after 14 to 28 days. in clinical trials. in clinical trials.

Vaccination 130

Vaccination Vaccine Gene Therapy Clinical Trials 130

Pharmaceutical Technology

JANUARY 11, 2023

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Gene Therapy 147

Gene Therapy Gene Development Licensing 147

FDA Law Blog

MARCH 13, 2024

Karst — After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156 for certain FDA-regulated products, we know what you were thinking. Part 3: Who’s Buried in Grant’s Tomb?

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

Pharmaceutical Technology

NOVEMBER 30, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. The University of Texas Medical Branch (UTMB) and HDT Bio have received a funding worth up to $87.4m Free Whitepaper. By Cytiva Thematic.

Vaccination 147

Vaccination Vaccine Development Gene Therapy 147

Pharmaceutical Technology

FEBRUARY 17, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The latest move follows an exclusive distribution deal signed by the companies for CAP-1002 in the US in January last year. Topic sponsors are not involved in the creation of editorial content.

Gene Therapy 130

Gene Therapy Sales Clinical Development Gene 130

Pharmaceutical Technology

JANUARY 12, 2023

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Solid Biosciences stated that the partnership boosts its scientific capabilities along with commercial potential in cardiac therapy.

RNA 130

RNA Gene Therapy Genetics Genetic Disease 130

Pharmaceutical Technology

MARCH 1, 2023

Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Tevard Biosciences and Vertex Pharmaceuticals have announced a four-year global research partnership to develop new tRNA-based therapies to treat Duchenne muscular dystrophy (DMD) patients.

Development 130

Development Gene Therapy Genetics Genetic Disease 130

WCG Clinical

NOVEMBER 20, 2023

WCG’s IRB has identified two broad types of deficiencies which frequently lead to the IRB’s inability to determine the Criteria for Approval are met: Regulatory status of the test article(s) is/are not provided, and Submitted protocol information is incomplete. By law, when a 1571 is submitted, FDA must respond within 30 days with a decision.

Research 52

Research Clinical Trials Clinical Trials Production 52

Pharmaceutical Technology

DECEMBER 14, 2022

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Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

Pharmaceutical Technology

DECEMBER 20, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. In the Breyanzi group, the median PFS was observed to be 14.8 months versus 5.7 months for the standard therapy arm. Free Whitepaper.

Gene Therapy 147

Gene Therapy Trials Gene Clinical Trials 147

Pharmaceutical Technology

JANUARY 10, 2023

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Gene Therapy 130

Gene Therapy Sales Gene Production 130

Pharmaceutical Technology

JANUARY 4, 2023

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Engineer 130

Engineer Gene Therapy Gene Development 130

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). See 21 CFR 807.81(a)(3)

Manufacturing 98

Manufacturing Marketing Regulation Cosmetics 98