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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

They may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologics include a wide range of products , including: Vaccines. Allergenics.

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

The Pharma Data

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52
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Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

HR 52
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Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

Drugs 69
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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

Drugs 110
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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR 52