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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Monoclonal antibodies (mAbs). Blood and blood components. Allergenics. Somatic cells. Gene and cellular therapies. Recombinant therapeutic proteins. Growth factors. Fusion proteins.

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News from AACR 2024: Wednesday’s highlights

Drug Discovery World

The company reported that these data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase II study. And thanks to the city of San Diego for its hospitality.”

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Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

The Pharma Data

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement.

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Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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Pfizer Responds to Research Claims

Pfizer

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In addition, to meet U.S. and around the world.

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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).