Drug Discovery World
APRIL 4, 2023
The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February.
Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels.
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Drug Discovery World
AUGUST 14, 2023
While CGT is still an emerging market, its growth has accelerated over the last five years, resulting in a wave of products approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). And the robust CGT pipeline suggests there could be an influx of new approvals on the horizon.
XTalks
APRIL 24, 2023
Out of over 7,000 rare diseases, only 5 percent (or less) of rare diseases are thought to have approved treatment options, known as “orphan” therapies. Dr. Eagleton recently spoke on a webinar with his colleagues from Medpace about lessons learned from successful approaches from rare disease and gene therapy product approvals.
The Pharma Data
DECEMBER 13, 2020
Based on the feedback received at the meeting with FDA, Gamida Cell intends to submit a full BLA for omidubicel in the second half of 2021 in lieu of the company’s previous plan to initiate a rolling BLA submission by the end of 2020. chief executive officer of Gamida Cell. About Omidubicel.
XTalks
AUGUST 17, 2020
This typically involves taking T cells from the body, engineering chimeric receptor antigens (CAR) and inserting them into the cells, expanding the cells ex vivo and injecting them back into the body. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. Immune system modulators (i.e.
The Pharma Data
DECEMBER 10, 2020
.–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. This blocking of viral replication was observed in both the lung and nasal passages.
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