Remove 2011 Remove Clinical Development Remove FDA Approval
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International Women’s Day: Female life science leaders

Drug Discovery World

Linda Powers, CEO, Northwest Biotherapeutics Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011. Other roles include Head of Biology at TopoTarget A/S, where she was responsible for the pre-clinical development of belinostat which went on to gain FDA approval to treat peripheral T-cell lymphoma.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

Science 40
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A research team searches for every gene that helps tumors evade immunotherapy

Broad Institute

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors.

Research 137
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EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The Pharma Data

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits.

The Pharma Data

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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GBT Presents Data at 15th Annual Scientific Conference on Sickle Cell and Thalassemia

The Pharma Data

FDA approval. About Global Blood Therapeutics Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities.

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The genetic modifier approach: identifying the right target for rare diseases

Drug Target Review

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

Disease 111