A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
News information is not all-inclusive. Please check back for updates.
FDA Actions
Diagnostics Update: The FDA has now worked with 220 test developers. To date, 17 EUAs have been issued, including the AvellinoCoV2 test. The FDA has also been notified that more than 100 laboratories have begun testing.
3D Printing: The FDA entered into a Memorandum with various organizations that provides a framework for collaboration to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19.
Diagnostics
BGI Genomics received FDA EUA for its RT-PCR kit for SARS-CoV-2 detection.The test can return results for COVID-19 within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in bronchoalveolar lavage fluid and throat swabs.
Testing Therapies, Antivirals and Vaccines
Sanofi Pasteur, the vaccines business for French pharma giant Sanofi, and Massachusetts-based Translate Bio have partnered to develop a novel messenger RNA (mRNA) vaccine for COVID-19, the disease caused by the novel coronavirus.
CytoDyn filed another round of modifications to its IND and protocol for a Phase II clinical trial with leronlimab in COVID-19 patients in severe condition. The company also reported that the drug had been tested in seven patients with severe COVID-19 under an Emergency IND granted by the FDA. The three-day results after treatment of the first four patients showed an improved immune profile, controlling the cytokine storm.
Vyripharm Biopharmaceuticals is repurposing the development of a novel theranostic platform for the diagnosis, monitoring and treatment of viral infections such as SARS, MERS and COVID-19. This theranostic approach will use radiopharmaceuticals for detection and diagnosis with the ability to incorporate combination therapies to interrupt the replication of the virus, the company said. The therapeutic application will begin with a CB1 antagonist, an anti-viral therapeutic formulation and followed by a short course of radiotherapeutic regimen in combination or in a dose-related response manner.
As reported by CNBC, the World Health Organization officials announced on Friday that the first patients in a “historic” drug trial to test treatments for the coronavirus have been enrolled in Norway and Spain.
Company Actions
BMS, Merck, Pfizer and Enanta Pharmaceuticals join Eli Lilly, Galapagos and other companies are pausing enrollment to some clinical trials during the COVID-19 pandemic. Other companies, such as AbbVie and Amgen, continue to closely monitor their trial sites.
Other Industry News
Cerus Corporation formed a collaborative research group with the aim of optimizing convalescent plasma therapy for COVID-19 patients. The research group seeks to define the key characteristics that influence the efficacy of convalescent plasma, including the level and nature of anti-COVID-19 antibodies, optimal collection timing, dosing and how these influence responses to the therapy regimen. Cerus’ INTERCEPT Blood System, a pathogen reduction technology, has approved label claims for SARS-CoV inactivation in both the U.S. and Europe. SARS-CoV-2 is the causative agent of COVID-19 and the genetic sequence is at least 70% similar to that of SARS-CoV, the company said.
Ireland-based Medtronic launched a new online solution to assess, monitor and triage support for patients concerned about COVID-19 and respiratory symptoms. The company’s new COVID-19 Virtual Care Evaluation and Monitoring solution uses a virtual assistant to evaluate patients through a Centers for Disease Control and Prevention guideline-based survey for COVID-19 symptoms. If the user’s symptoms warrant it, the solution connects them to the Medtronic Care Management Services nurse command center, where registered nurses review the patient’s data and either identify recommendations or the need for additional care assessment, based on the CDC guidelines. This could include a recommendation to continue monitoring symptoms at home or to contact a healthcare provider directly.
