The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. About KEYNOTE-158.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

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The Pharma Data

APRIL 4, 2022

The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S.

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Drug Target Review

OCTOBER 10, 2024

Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinical development and escalate costs. In conclusion, over-reliance on healthy donor material in cell therapy development creates a precarious foundation for clinical translation.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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The Pharma Data

JANUARY 13, 2021

said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function 1. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

DECEMBER 9, 2020

Additionally, the capital will be used to further expand the existing laboratory capacities. announced a research collaboration to develop hormone receptor antagonist (GHRA) peptides as potential treatments for acromegaly, a rare but serious endocrine disorder with significant unmet medical need.

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The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Merck will not receive any milestone payments for the development of lonafarnib for the treatment of Progeria, and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

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The Pharma Data

MARCH 4, 2021

vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.” They lose much more than just hair,” said Lotus Mallbris, M.D.,

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The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. The most common Grade 3 or 4 laboratory abnormalities (?2%) 8] , [9] , [10] , [11] , [12]. **In

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

OCTOBER 29, 2020

vice president of immunology development at Lilly. “The results of this study underscore baricitinib’s potential in alopecia areata, and we look forward to continuing the clinical development program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.”

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease.

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The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

OCTOBER 26, 2020

billion related to certain license and collaboration agreements, and certain other items. Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Non-GAAP EPS of $1.74

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The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Senior Vice President and Head of Global Clinical Development at Regeneron.

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The Pharma Data

JUNE 30, 2021

Today’s results show us the potential power of cell therapy for patients with lymphoma when used earlier, and instead of standard treatment options,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. The most common non-laboratory adverse reactions (incidence ?20%)

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). R&D: Up-front payments related to license and collaboration agreements. (85).

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The Pharma Data

DECEMBER 27, 2020

Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%), and anemia (8%) based on laboratory measurements, were reported in patients treated with BRUKINSA monotherapy. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Cytopenias.

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Merck’s Commitment to HIV.

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