The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Clinical Supply Gene Therapy Gene Development 52

XTalks

JUNE 16, 2023

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

Drugs 98

Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

Pharmaceutical Technology

MAY 30, 2023

Bisphosphonates are drugs that slow the progression of bone loss. EffRx has received several European regulatory approvals for drugs in its portfolio. Alkindi is one of EffRx’s three marketed drugs. In Italy, Abiogen began distributing its bisphosphonates in 2014 and has since seen some successful drug approvals.

Contract Manufacturing 130

Contract Manufacturing Clinical Supply Drugs Licensing 130

XTalks

APRIL 6, 2023

IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management. IRT development is a very risk-averse business because IRT systems randomize patients and determine what investigational drug is administered to a participant, among other things.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Supply Trials 98

Pharmaceutical Technology

APRIL 28, 2023

Its scope includes Syngene providing integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. until 2026. Syngene’s collaboration with Zoetis started in 2011.

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Manufacturing Antibody Clinical Supply Protein 130

BioPharma Reporter

APRIL 27, 2021

Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.

Gene Therapy 52

Gene Therapy Clinical Supply Gene Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

The list includes clinical packaging service contractors with expertise in material science, industrial design and information technology and providing innovative and cost-effective clinical trial packaging solutions.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

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.

Clinical Supply Chain 52

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

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.

Clinical Supply 52

Clinical Supply Clinical Trials Clinical Trials Life Science 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. Managing drug supply in the midst of unexpected and changing circumstances can be overwhelming.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130

The Pharma Data

DECEMBER 14, 2020

Over the last two years, AlgoTherapeutix took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production.

Clinical Development 52

Clinical Development Development Clinical Supply Packaging 52

pharmaphorum

NOVEMBER 2, 2022

“This collaboration is an exciting opportunity to complement CSL’s own next-generation mRNA programme with a partner who developed a platform to deliver late stage clinical supplies at scale,” said CSL’s chief operating officer Paul McKenzie.

Vaccination 52

Vaccination Vaccine Immune Response Gene Therapy 52

The Pharma Data

JANUARY 10, 2021

for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., In July 2020, the U.S.

Containment 52

Containment Clinical Development Antibody Development 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.

Regulation 59

Regulation Clinical Trials Clinical Trials Trials 59

The Pharma Data

NOVEMBER 22, 2020

Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

Trials 40

Trials Protein Clinical Trials Clinical Trials 40

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.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 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.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 52

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130

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.

Regulation 40

Regulation Clinical Trials Clinical Trials Trials 40

The Pharma Data

DECEMBER 4, 2021

The companies are exploring these advances through their newly created Pfizer Amazon Collaboration Team (PACT) initiative, which applies AWS capabilities in analytics, machine learning, compute, storage, security, and cloud data warehousing to Pfizer laboratory, clinical manufacturing and clinical supply chain efforts.

Manufacturing 52

Manufacturing Development Drugs Clinical Supply Chain 52

The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Clinical Development 52

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. About VTX-801.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Supply Chain 52

The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

Development 40

Development Protein Manufacturing Medicine 40

Cloudbyz

AUGUST 15, 2024

Supply Chain Management: Manages inventory, shipment, and resupply of trial drugs. How do RTSM systems address the challenge of drug accountability in clinical trials? Reconciliation Reports: Generating reports that reconcile the amount of drug shipped, dispensed, returned, and destroyed.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52