Clinical Development, Clinical Trials, Contract Manufacturing and Manufacturing

Interview: The evolution of data management in clinical development

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

Risk adjusted net present value: What is the current valuation of Pfizer’s PF-06835375?

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. The drug candidate is administered through intravenous or subcutaneous route.

Contract Manufacturing

Contract Manufacturing Manufacturing Production Pharmacy

Enzalutamide by Pfizer for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Hormones

Hormones Contract Manufacturing Manufacturing Development

Enzalutamide by Pfizer for Myelofibrosis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Myelofibrosis. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Hormones

Hormones Contract Manufacturing Manufacturing Development

Enzalutamide by Pfizer for Relapsed Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Hormones

Hormones Contract Manufacturing Manufacturing Development

ADCs Pipeline Update: Avacta Partners with ADC Therapeutics

Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

Antibody

Antibody Licensing Licensing Contract Manufacturing

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Manufacturing

Manufacturing Vaccination Vaccine Clinical Trials

Lumos Pharma’s Patient-Centric Strategy for Rare Disease Drug Development

XTalks

JANUARY 23, 2024

Hawkins: I started my professional journey at Johnson & Johnson, gaining extensive experience in both the preclinical and clinical development of pharmaceuticals, as well as regulatory insights. Together, we developed the world’s first growth hormone receptor antagonist, Somavert (pegvisomant), targeting acromegaly.

Development

Development Hormones Drugs Trials

First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development

The Pharma Data

AUGUST 3, 2021

Boehringer Ingelheim also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor, for improving cognition in adults with schizophrenia. In the first six months, the company generated net sales of 9.8

Development

Development Research Contract Manufacturing Sales

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Corporate and Business Development Update. Business Highlights.

Sales

Sales Production Manufacturing Antibody

Athersys to Host a Virtual Investor Day

The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

Athersys Announces Three Appointments to Board of Directors

The Pharma Data

NOVEMBER 15, 2020

MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. About MultiStem ®.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

Clinical Research Informer

Interview: The evolution of data management in clinical development

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Trending Sources

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Risk adjusted net present value: What is the current valuation of Pfizer’s PF-06835375?

Enzalutamide by Pfizer for Relapsed Multiple Myeloma: Likelihood of Approval

Enzalutamide by Pfizer for Myelofibrosis: Likelihood of Approval

Enzalutamide by Pfizer for Relapsed Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval

ADCs Pipeline Update: Avacta Partners with ADC Therapeutics

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

Lumos Pharma’s Patient-Centric Strategy for Rare Disease Drug Development

First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Athersys to Host a Virtual Investor Day

Athersys Announces Three Appointments to Board of Directors

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

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