Remove Hormones Remove Protein Remove Trials
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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen. AstraZeneca stated that its NDA is being reviewed under Project Orbis.

HR 245
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Povorcitinib Phase III Results Stir Mixed Signals for Incyte and Investors

XTalks

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. By inhibiting this protein, povorcitinib reduces the inflammatory signals that contribute to abscess and nodule formation. for placebo.

Trials 59
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Pfizer puts up $1bn to buy into Arvinas breast cancer programme

pharmaphorum

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease.

Protein 116
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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. Recombinant therapeutic proteins. Fusion proteins. Gene and cellular therapies. Growth factors. Interferons. Monoclonal antibodies (mAbs).

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Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

XTalks

Hereditary ATTR has an autosomal dominant pattern of inheritance and is caused by point mutations in the transthyretin ( TTR ) gene that codes for the transthyretin transport protein found in the plasma and cerebrospinal fluid. Evaluate Vantage speculates that given Amvuttra’s potential for ATTR cardiomyopathy, the drug could reach $1.8

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. Acromegaly. Prevalence: 50 to 70 people per 1 million.

Trials 98
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Protein Precision: “Harnessing Targeted Protein Degradation”

Roots Analysis

Proteins are the chains of amino acids linked together in different combinations and perform a wide variety of functions. However, continuous regulation of the cellular proteome is essential for maintaining the right balance of different proteins necessary for normal cellular function, survival, and proliferation.

Protein 40