The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept.

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The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. VectivBio AG – Based in Switzerland, VectivBio named Sarah Holland as chief business officer and Aditya Venugopal as head of business development. Before GSK, Rosén was senior vice president, U.S.

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The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

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The Pharma Data

DECEMBER 15, 2020

1 Macarulla Mercade et al, Pancreas 2020 2 Petrelli et al Eu J Cancer 2017 3 Onivyde prescribing information 4 Wang Gillam Eu J Cancer 2019. NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. . Disease control rate (DCR).

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The Pharma Data

OCTOBER 28, 2020

GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. About Ultragenyx.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., Before that, Ms. About MultiStem ®.

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The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation.

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The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. The roots of Bayer’s platform began in 2014, when the company stepped into the gene therapy space through a collaboration for hemophilia A with Dimension Therapeutics, which was later acquired by Ultragenyx in 2017.

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The Pharma Data

APRIL 4, 2022

Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. 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. Regulatory filings around the world are also planned in 2022.

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Advarra

AUGUST 10, 2023

FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval.

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The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. 20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein].

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Drug Target Review

APRIL 11, 2025

Accelerating drug discovery with generative AI: case studies and timelines Pioneering efforts in applying generative AI (GenAI) on a large scale to drug discovery emerged in 2017, with companies like Insilico Medicine and AstraZeneca , alongside academic laboratories.

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The Pharma Data

JUNE 30, 2021

ZUMA-7 was initiated in 2017 and enrolled 359 patients in 77 centers around the world. 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.

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The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL.

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Drug Target Review

MARCH 20, 2025

Regulatory approval and market introduction Anthos Therapeutics is actively pursuing the clinical development of abelacimab. “This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. .

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