Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers.

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Drug Discovery World

AUGUST 8, 2023

.” “At Merck, we are always seeking new and innovative ways to optimise process efficiency while maintaining product integrity,” said Dr Michael Kress, Senior Vice President, Development Sciences and Clinical Supply, Merck Research Laboratories. The post Ginkgo Bioworks and Merck collaborate to improve biologic manufacturing (..)

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Manufacturing Clinical Supply Production Engineer 52

The Pharma Data

SEPTEMBER 14, 2020

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Maintaining optimization during clinical trial design.

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Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. Underproduction and drug stockouts can result in patients not receiving scheduled doses.

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pharmaphorum

NOVEMBER 2, 2022

billion on offer in milestones if the programmes meet development and commercial objectives. According to a statement from the two companies, Arcturus will contribute its STARR self-amplifying mRNA vaccine and LUNAR lipid nanoparticle delivery platform, which has already been deployed in the development of COVID-19 vaccine ARCT-154.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. Food and Drug Administration (“FDA”) approval.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

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Containment Clinical Development Antibody Development 52

Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. CGT drugs fall into two major categories: autologous and allogeneic. Differences in CGT vs traditional trials supply chain.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

The Pharma Data

SEPTEMBER 18, 2020

BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and gene therapy candidates to support the development of its diversified cancer and infectious disease product pipeline.

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Vaccination Vaccine Manufacturing Clinical Supply Chain 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for Syros Pharmaceuticals’ SY-5609 for the treatment of pancreatic cancer. . The Phase I clinical trial that is underway is assessing SY-5609 plus chemotherapy in subjects with pancreatic cancer whose disease has advanced after Folfirinox treatment.

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Drugs Clinical Supply Trials Clinical Trials 130

XTalks

APRIL 6, 2023

Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management. How is Modern Software Impacting IRT Platforms?

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Clinical Trials Clinical Trials Clinical Supply Trials 98

Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. The 10-year agreement is for manufacturing the drug substance for Librela® (bedinvetmab), a first-in-class monoclonal antibody used for treating osteoarthritis in dogs. until 2026.

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The Pharma Data

DECEMBER 4, 2021

company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials. (AWS), an Amazon.com, Inc.

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Manufacturing Development Drugs Clinical Supply Chain 52

Drug Discovery World

MARCH 13, 2023

While there is no silver bullet for increasing the availability of CGTs, improving manufacturing processes that enable their development at scale can help reduce the cost of these treatments and get them to those who need them most. One example: Zynteglo, a newly approved gene therapy priced at a record-breaking $2.8M

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

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Client Pharma

DECEMBER 13, 2021

Collaboration provides clinical trial sponsors with access to the world’s most efficient clinical supply processes using a single contract. As a result, global clinical supply and operations teams can now single source their commercial drug requirements by utilizing two best-in-class solution providers.

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Clinical Supply Clinical Trials Clinical Trials Life Science 52

VirTrial

APRIL 18, 2024

The data highlights fast or slow recruitment and how the drug supply is managed. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

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Drug Discovery World

NOVEMBER 3, 2022

Paul Viggers , Chief Commercial Officer at TrakCel, explains how it fits into the drug discovery and development sector. . 1 Emily was a seven-year-old girl who relapsed a second time following two years battling leukaemia, out of standard treatment options, and her life was saved by a CAR-T treatment in early clinical trial.

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The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.

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Gene Therapy Gene Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Chief Medical Officer of Molecular Partners.

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Pharmaceutical Technology

MARCH 20, 2023

These high rates of diseases in largely untapped patient pools, present invaluable opportunities to trial new drugs that can help people living with chronic conditions and battling serious illnesses. This is because many patients in these regions already have access to comparable drugs. You have a drug-naïve population in Africa.

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Pharmaceutical Technology

MAY 23, 2023

Oncology was the main therapy area, accounting for 218 trials, followed by central nervous system drugs having 185, and infectious diseases next with 138. Multinational clinical trials dominated the total with 95% at 1,119, compared with 58 for single-country trials – or just under 5%. Credit: Oximio.

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