Y-mAbs Therapeutics, Inc. a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration has approved DANYELZA (naxitamab-gqgk) 40mg/10ml.
Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration
USFDA approved for its Abbreviated New Drug Application (ANDA) for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation). The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie Inc. (AbbVie).
Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).
Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of US$ 107 million for twelve months ending September 2020 according to IQVIA.
Alembic has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from USFDA.
Applied DNA Sciences, Inc a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that expands the installed base of RT-PCR platforms that can process the Company’s Linea™ COVID-19 Assay Kit. The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems’ (ThermoFisher Scientific) QuantStudio™ Dx and QuantStudio™ 5 Real-Time PCR systems to include Applied Biosystems™ 7500 Fast Dx Real-Time PCR System (ABI 7500). The ABI 7500 has the capacity to perform 400 – 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.
“With this amendment to our EUA, we significantly increase the number of authorized devices on which our assay kit can run and remove a gating factor to the more widespread adoption of our high sensitivity test,” said Dr. James A. Hayward, president and CEO, Applied DNA. “We are actively engaged with clinical laboratories nationally with which our opportunities for assay kit contracts are bolstered by the addition of an RT-PCR system in wide use by the diagnostics industry. Additional planned amendments, we believe, will further differentiate our assay in the marketplace and to operators of clinical diagnostic labs.”
Update on Applied DNA Clinical Laboratories CLEP-CLIA Certification
Separately, the Company announced that an inspection report from the State of New York Department of Health (DoH) following the DoH’s initial inspection of Applied DNA Clinical Laboratories, LLC (ADCL) on October 7, 2020, highlighted deficiencies in ADCL’s clinical standard of practice at the time of inspection that require remediation prior to the submission of a re-inspection request. The Company expects to complete remediation actions during the first calendar quarter of 2021. In the interim, ADCL’s safeCircle™ platform, its pooled COVID-19 surveillance testing program that does not require CLEP-CLIA certifications, is leveraging infrastructure designated for diagnostic testing to support safeCircle clients and Applied DNA’s internal surveillance testing program for employees.
“While disappointed with the push-out in our CLEP-CLIA certification timeline, our pooled surveillance testing platform can generate more revenue per pooled sample comprising 5 individuals than from the diagnostic testing of 1 individual in the same amount of time and using the same personnel, procedures, and equipment,” concluded Dr. Hayward. “Surveillance testing is readily scalable, and in recent weeks, we have concentrated our efforts on ramping up surveillance testing capacity. Our sales efforts are focused on tapping into the need for consistent, ongoing, and high sensitivity PCR-based COVID-19 testing that is becoming as foundational to stopping the spread of the virus as masks, handwashing, and social distancing. We believe the value of our safeCircle platform is that its sensitivity allows our clients to identify and isolate infected populations early – in many cases before population members suspect they are ill – to help break the chain of transmission that could otherwise fuel the exponential growth of COVID-19.”
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