The Pharma Data
DECEMBER 15, 2020
Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.
The Pharma Data
NOVEMBER 2, 2020
We will also use data provided by our Korean R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative. The same data that will be produced by the company’s Pennsylvania testing partner will be used for submissions to the EU and Russian Federation.
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The Pharma Data
JULY 21, 2021
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Roots Analysis
FEBRUARY 15, 2022
Specifically, the multi-step process of production of cytotoxic payloads, which are used in ADCs, requires a contained environment, dedicated manufacturing facilities, specialized analytical and purification techniques, and storage facilities. As per the estimates, 70-80% of ADC manufacturing operations are outsourced.
The Pharma Data
DECEMBER 23, 2020
INOVIO is also assessing nonclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia.
The Pharma Data
NOVEMBER 5, 2020
The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50% Oncology Program. 50% PD-L1 expression. 30%. *. *.
The Pharma Data
JANUARY 27, 2021
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
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