Pfizer's elranatamab granted FDA Breakthrough Therapy Designation for relapsed or refractory multiple myeloma
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM). Elranatamab is a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery
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- Category: Business
Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.
This submission comes after two successful phase III clinical trials conducted between 2020 and 2021.
Pfizer and BioNTech announce positive early data from clinical trial of Omicron BA.4/BA.5-adapted bivalent booster in individuals 18 years and older
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).
Bayer signs grant agreement to advance innovation in non-hormonal contraception
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- Category: Bayer
Bayer announced that it has received a grant from the Bill & Melinda Gates Foundation. As part of the grant, Bayer and the Bill & Melinda Gates Foundation have each committed more than US$ 12 million over four years to co-fund pre-clinical research activities with the goal of providing women globally with an option for non-hormonal contraception.
GSK announces expanded collaboration with Tempus in precision medicine to accelerate R&D
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) and Tempus, a US-based precision medicine company, have entered into a three-year collaboration agreement that provides GSK with access to Tempus' AI-enabled platform, including its library of de-identified patient data. Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets.
Pfizer completes acquisition of Global Blood Therapeutics
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced the completion of its acquisition of Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities starting with sickle cell disease (SCD).
Lilly receives U.S. FDA Fast Track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities
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- Category: Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.
More Pharma News ...
- Pfizer completes acquisition of Biohaven Pharmaceuticals
- Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
- Pfizer to supply Global Fund up to 6 million PAXLOVID™ treatment courses for low-and-middle-income countries
- WHO grants prequalification to GSK's Mosquirix - the first and only approved malaria vaccine
- Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in European Union
- Novartis invests in early technical development capabilities for next-generation biotherapeutics
- FDA grants Breakthrough Therapy Designation to Pfizer's Group B Streptococcus vaccine candidate