George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
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apologies if posted:
https://www.evaluate.com/vantage/articles/news/tiziana-takes-deep-breath-and-targets-covid-19
Cheers N-M, shouldn't be too much longer before news arrives and a sudden and significant re-rate in sp, given the urgency to find a treatment and the FDA's new plans to accelerate development etc.....Gl ;-)
Good find moneymunch. Make no doubt about it we do need news here. But good news would provide us with significant upside. A quieter day so far trades wise, volume at just 144k, even so the price has been quite volatile throughout the day so I suspect yet again we may see some delayed trades published after hours. Will report later.
1 April 2020
News
FDA launches new programme to speed-up Covid-19 therapies
The US Food and Drug Administration (FDA) has launched a new programme aimed at accelerating the development of potential treatments for Covid-19 infection.
Under the Coronavirus Treatment Acceleration Program (CTAP), FDA is working to quickly bring therapies to patients.
Furthermore, the agency is supporting research to validate the safety and effectiveness of these Covid-19 treatments.
Commenting on the programme, US Department of Health & Human Services secretary Alex Azar said: “The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible.
“As part of this new programme, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.”
Currently, multiple companies and researchers are working on Covid-19 therapies.
FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing guidance and assistance under the agency’s accelerator programme.
Furthermore, the agency is working with federal partners, developers and researchers to devise protocols for use across institutions and programmes.
FDA Commissioner Stephen Hahn said: “Quickly after the emergence of this virus, we began working directly with federal health partners, academia and industry to advance medical countermeasures against Covid-19.
“Our staff continues to work across all sectors to expedite the development of numerous, innovative potential prevention and treatment approaches. We are also looking at pragmatic and expedited ways to make these products available to patients, while still ensuring the FDA’s standards are met.”
To support the fight against the pandemic, the regulator reassigned medical and regulatory staff, as well as designed specific processes and operations, for developers and scientists.
Therapies, developed across different areas, include antiviral drugs such as remdesivir, interleukin-6 (IL-6) receptor inhibitors and existing drugs such as hydroxychloroquine.
FDA is also collaborating with various public and private partners to rapidly gather and analyse real-world data, including illness trends and treatment outcomes.
The aim is to expedite the collection of clinical trial data required to approve a therapy for marketing.
We could also get additional funding for the patient trials from BARDA, if and when they get the green light. Gla ;-)
Biomedical Advanced Research and Development Authority
Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID).
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22/3/20
BARDA throws weight behind Kevzara, Actemra studies as IL-6 inhibition gains momentum for late-stage COVID-19
Mar 22, 2020
HHS will fund trials of Regeneron’s Kevzara and Genentech’s Actemra to treat COVID-19. Both IL-6 inhibitors, which will be evaluated in patients with later-stage disease and respiratory deterioration, entered pivotal studies in the past week.
The agency said Saturday it would fund the Phase II/III study of Kevzara sarilumab, the start of which was announced March 16 by Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NASDAQ:SNY). The adaptive trial is to enroll up to 400 hospitalized patients with severe disease, who will receive best supportive care plus Kevzara or placebo.
The trial’s first part will evaluate Kevzara’s impact on fever and patients’ need for supplemental oxygen, the agency said. A larger second part will examine longer-term outcomes, including effects on mortality and the need for mechanical ventilation, supplemental oxygen, or hospitalization.
On Monday, Genentech said FDA has cleared the start of a 330-patient Phase III trial of Actemra tocilizumab in hospitalized patients with severe COVID-19 pneumonia, which HHS’s Biomedical Advanced Research and Development Authority (BARDA) is backing as well. Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), said March 19 that it would start the global, placebo-controlled trial, which is evaluating Actemra plus best supportive care.
Genentech said it would provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile as well.
According to ClinicalTrials.gov, the primary completion date is in December 2020 for the Actemra study, and in March 2021 for the Kevzara trial.
IL-6 inhibitors such as Kevzara and Actemra may ameliorate the immune response that leads to acute respiratory distress syndrome (ARDS) in patients with COVID-19. Anti-inflammatory could play a role in the treatment strategy for patients with advanced disease after respiratory function has begun to deteriorate. Evidence is emerging that antivirals are mainly effective earlier in the treatment paradigm (see “Slotting Anti-Inflammatories Into Treatment”).
Kevzara and Actemra are both approved to treat rheumatoid arthritis.
In Saturday’s announcement, HHS said BARDA’s funding for the Kevzara trial was “among the first” from H.R. 6074, the coronavirus appropriations legislation