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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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

Pharmaceutical Technology

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company offers consumer, prescription and automation products. Its investigational medicinal products comprise R-107, R-131 and R-147.

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

Pharmaceutical Technology

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company offers consumer, prescription and automation products. Its investigational medicinal products comprise R-107, R-131 and R-147.

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Enzalutamide by Pfizer for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,

Hormones 113
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Enzalutamide by Pfizer for Myelofibrosis: Likelihood of Approval

Pharmaceutical Technology

Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,

Hormones 100
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Enzalutamide by Pfizer for Relapsed Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval

Pharmaceutical Technology

Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,

Hormones 100
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Outsourcing Peptide Synthesis: Preferred Choice of Drug Developers

Roots Analysis

However, there are several challenges and complexities that impact both product yield and purity associated with the peptide synthesis and purification of complex long-chain macromolecules. They also play important roles in antibiotics , toxins, hormones, and enzymes. It is a preferred techniques for creating a 40-amino acid peptide.