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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

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3 Things You Need to Know About Xtalks’ New Food Podcast

XTalks

She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences. She also writes informative blogs on topics including drug development, life science company profiles and HR content pertaining to the pharma and biotech industries.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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Merck’s KEYTRUDA® (pembrolizumab) Receives Two New Approvals in Japan

The Pharma Data

KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. months (95% CI, 7.6-11.3) months (95% CI, 5.3-7.5), months [95% CI, 5.4-32.4]

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Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy.

The Pharma Data

This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-590 trial. KEYTRUDA plus 5-FU and cisplatin reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; 0.86]; p<0.0001). The median OS was 12.4 months (95% CI, 10.5-14.0) months (95% CI, 8.8-10.8)

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Six months after authorization, what do we know about Paxlovid?

pharmaphorum

Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent. Paxlovid consists of two different drugs, nirmatrelvir 150mg tablets co-packaged with ritonavir 100mg tablets.

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