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.”
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Hetero, one of India’s leading generic pharmaceutical companies (through its biologics arm “Hetero Biopharma”) have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection – Sputnik V.
The parties intend to start the production of Sputnik V in the beginning of 2021.
The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers. Interim trial results have once again confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. Evaluation of efficacy was carried out among volunteers (n = 18,794) 28 days after receiving the first dose (7 days after the second dose) of the vaccine or placebo upon reaching the second control point of the trial in compliance with the clinical trial protocol. The analysis demonstrated a 91.4% efficacy rate for the Sputnik V vaccine.
The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses. So, preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95%.
Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.
The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades - while the history of use of human adenoviruses in vaccine development started in 1953. Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so called "spikes" forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body's stable immune response.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:
“We are delighted to announce the agreement between RDIF and Hetero that will pave the way to production of the safe and highly effective Sputnik V vaccine on Indian soil. The vaccine’s interim clinical trial results show 95% efficacy on the 42nd day after the first dose. I am confident that Sputnik V should become an integral part of the national vaccine portfolio of every country willing to protect its population from the coronavirus. Thanks to our cooperation with Hetero, we will be able to significantly increase production capacity and provide people of India with an efficient solution in this challenging period of the pandemic”.
B. Murali Krishna Reddy, Director – International Marketing, Hetero Labs Limited commented:
“We are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of Covid-19. While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients. This collaboration is another step towards our commitment in the battle against Covid-19 and realizing the objective of ‘Make-in-India’ campaign as envisioned by our Hon’ble Prime Minister of India.”
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