EUA

Lucira Health to Pursue Strategic Sale of its Business Through Voluntary Chapter 11 Process

Retrieved on: 
Wednesday, February 22, 2023
Influenza, Bankruptcy, Lucira, United States Bankruptcy Court for the Southern District of New York, LLP, Workforce, Insurance, OTC, Cooley LLP, Chapter 11, Title 11, United States Code, Food and Drug Administration, Bankruptcy Code, COVID-19, Tax, EUA, Sale, United States bankruptcy court, Pharmaceutical industry

The Company further disclosed that it intends to pursue a sale of its business under Section 363 of the Bankruptcy Code, while continuing to support its customers during the Chapter 11 process.

Key Points: 
  • The Company further disclosed that it intends to pursue a sale of its business under Section 363 of the Bankruptcy Code, while continuing to support its customers during the Chapter 11 process.
  • As such, the Company’s operations were significantly impacted, leading to the Chapter 11 filing and sale process.
  • Further, the Company engaged Armanino LLP, an independent accounting and business consulting firm in the United States, to pursue various strategic options, including a potential sale process.
  • Such motions are typical in the Chapter 11 process and Lucira anticipates they will be heard in the first few days of its Chapter 11 case.

Spectrum Solutions Receives FDA 510(k) Class II Medical Device Clearance for SDNA Saliva Collection Device

Retrieved on: 
Wednesday, February 22, 2023
COVID-19, Medical Devices, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, COVID-19 testing, Saliva, LDT, IVD, Collection, Viral, Hospital, Virus, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SDNA, Certification, EUA, Failure, Multimedia, Food, Physician, SARS-CoV-2, Medical device, Vaccine

Spectrum Solutions today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA Saliva Collection Device as a microbial nucleic acid storage and stabilization device.

Key Points: 
  • Spectrum Solutions today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA Saliva Collection Device as a microbial nucleic acid storage and stabilization device.
  • View the full release here: https://www.businesswire.com/news/home/20230222005394/en/
    Spectrum Solutions has received FDA 510(k) Class II Medical Device Clearance for SDNA Saliva Collection Device.
  • The device is heralded for its ability to maximize detection at the lowest levels and neutralize viruses within 10-seconds of collection to mitigate unnecessary viral exposure.
  • “This 510(k) clearance and certification as an IVD molecular diagnostic device enables physicians, hospitals, researchers and others to leverage our SDNA Saliva Collection Device in a broad array of FDA approved and LDT diagnostic testing applications,” said Stephen Fanning, CEO at Spectrum Solutions.

AbCellera Reports Full Year 2022 Business Results

Retrieved on: 
Tuesday, February 21, 2023
Biotechnology, Pharmaceutical, Health, General Administration of Sport of China, Bamlanivimab, AbCellera, Partnership, Research, Webcast, S&M, Research and development, Investment, Bebtelovimab, R, Growth, Sales & Marketing Executives International, EUA, Administration, COVID-19, G&A, Video game, Reinsurance, Pharmaceutical industry

AbCellera started discovery on 23 partnered programs in 2022 to reach a cumulative total of 101 partnered program starts (up 29% from 78 on December 31, 2021).

Key Points: 
  • AbCellera started discovery on 23 partnered programs in 2022 to reach a cumulative total of 101 partnered program starts (up 29% from 78 on December 31, 2021).
  • AbCellera’s partners advanced an additional three molecules into the clinic in 2022, bringing the cumulative total to eight molecules in the clinic.
  • Revenue for the fourth quarter of 2022 was $21.5 million, representing 4% of the total for 2022.
  • AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

FDA Roundup: February 21, 2023

Retrieved on: 
Tuesday, February 21, 2023
China Biologic Products, CVM, Vaccine, Human services, Commissioner, Office of Inspector General, U.S. Department of Health and Human Services, Heated tobacco product, Animal, Veterinary medicine, Nociception, Pain, Safety, Patient, News, Software, Analgesic, Sensation, NOL, EUA, Marketing, FDA, Public, Dietary supplement, Multimedia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food and Drug Administration, Cosmetics, OTC, Food

SILVER SPRING, Md., Feb. 21, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Key Points: 
  • SILVER SPRING, Md., Feb. 21, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
    On Friday, the FDA published the FDA Voices: " Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back ," by Robert M. Califf, M.D., Commissioner of Food and Drugs.
  • On Friday, the FDA announced that after a robust recruitment and interview process, Tracey Forfa, J.D., a distinguished 30-year veteran of the agency, has been selected as the next Director of the FDA's Center for Veterinary Medicine (CVM), effective February 26, 2023.
  • As of today, 442 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).
  • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs.

Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Fully Human and Murine Anti-SARS-CoV-2 Monoclonal Antibodies

Retrieved on: 
Monday, February 13, 2023
Columbia University Vagelos College of Physicians and Surgeons, Hook effect, Mouse, Blood, Human, SARS-CoV-2, Therapy, Bangladesh Technical Education Board, Tonix Pharmaceuticals, Columbia University, Patient, Epitope, Food, Risk, Knowledge, Antibody, FDA, Physician, COVID, Regulation of tobacco by the U.S. Food and Drug Administration, COVID-19, Immunization, EUA, Mab, Pharmaceutical industry, Vaccine

CHATHAM, N.J., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.

Key Points: 
  • The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.
  • “The licensing of these mAbs strengthens our expanding pipeline of next-generation therapeutics to treat and prevent COVID-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • The fully human mAbs generated by Columbia University, TNX-3600, have been isolated using a proprietary system involving a human hybridoma fusion partner.
  • Dr. Lederman added, “The potential therapeutic antibodies licensed from Columbia University leverage our expanding internal development and manufacturing capabilities for biologics.

Anavasi Diagnostics Receives FDA Emergency Use Authorization for The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector

Retrieved on: 
Monday, February 13, 2023
Software, General Health, Hardware, Technology, Infectious Diseases, Clinical Trials, Nanotechnology, COVID-19, Medical Supplies, Other Technology, FDA, Health, COVID-19 testing, Omicron, PCR, NIH, Marketing, RSV, Clinical trial, RNA, Food, RT-LAMP, POC, Diagnosis, Emergency Use Authorization, Multimedia, COVID, Food and Drug Administration, EUA, Pharmaceutical industry, Vaccine

Anavasi Diagnostics , an NIH/RADx funded medical technology company developing novel molecular diagnostic testing for the point-of-care (POC) market, announced the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for The AscencioDx® COVID-19 Test and The AscencioDx® Molecular Detector .

Key Points: 
  • Anavasi Diagnostics , an NIH/RADx funded medical technology company developing novel molecular diagnostic testing for the point-of-care (POC) market, announced the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for The AscencioDx® COVID-19 Test and The AscencioDx® Molecular Detector .
  • (Photo: Business Wire)
    The AscencioDx® COVID-19 Test provides results for the detection of SARS-CoV-2 RNA in as little as 20 minutes.
  • The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector create less biowaste because the detector is reusable for at least 3,000 test cycles.
  • The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector are immediately available to qualified facilities.

Final Deadline Alert: Bronstein, Gewirtz & Grossman, LLC Reminds Veru Inc. (VERU) Investors of Class Action and to Actively Participate

Retrieved on: 
Monday, February 6, 2023
Class Action Lawsuit, Professional Services, Legal, FDA, Court, Complaint, NDA, Person, EUA, Verus Pharmaceuticals

Such investors are encouraged to join this case by visiting the firm’s site: www.bgandg.com/veru .

Key Points: 
  • Such investors are encouraged to join this case by visiting the firm’s site: www.bgandg.com/veru .
  • This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws.
  • or his Law Clerk and Client Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484.
  • Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Veru Inc. (VERU)

Retrieved on: 
Friday, February 3, 2023
Class Action Lawsuit, Professional Services, Legal, FDA, Court, Law, Suite, Verus Pharmaceuticals, COVID-19, News, EUA, Cryptocurrency, Pharmaceutical industry

The Law Offices of Frank R. Cruz reminds investors of the upcoming February 6, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Veru Inc. (“Veru” or the “Company”) (NASDAQ: VERU ) common stock between May 11, 2022 and November 9, 2022, inclusive (the “Class Period”).

Key Points: 
  • The Law Offices of Frank R. Cruz reminds investors of the upcoming February 6, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Veru Inc. (“Veru” or the “Company”) (NASDAQ: VERU ) common stock between May 11, 2022 and November 9, 2022, inclusive (the “Class Period”).
  • If you purchased or otherwise acquired Veru common stock during the Class Period, you may move the Court no later than February 6, 2023 to request appointment as lead plaintiff in this putative class action lawsuit.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

VERU DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Veru Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, February 2, 2023
Class Action Lawsuit, Professional Services, Legal, NDA, Acute respiratory distress syndrome, Standard of care, Trial of the century, Form 10-Q, Breast, Tiberius Claudius Verus, Safety, P.C, Patient, Telephone, Jeanne Eagels, News, Fast track (FDA), Prostate cancer, Mortality, Aerospace, Person, Death, Prostate Cancer Foundation, FDA, Court, Steiner, COVID-19, Fast Track, Infection, EUA, Pharmaceutical industry

Investors have until February 3, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until February 3, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers.
  • Veru also develops medicines for COVID-19 and other diseases related to viral and acute respiratory distress syndrome (“ARDS”), and has two FDA-approved products for sexual health.
  • Veru had originally developed sabizabulin with the intention of using it as a treatment for prostate cancer.

Cepheid Receives Emergency Use Authorization from FDA for Xpert® Mpox

Retrieved on: 
Tuesday, February 14, 2023
World Health Organization, Certificate, Monkeypox virus, Cepheid (company), COC, EVP, PCR, Diagnosis, Cor, Measles, POC, Simplex, Human, Cedillo v. Secretary of Health and Human Services, Syphilis, Infection, Chickenpox, Cow, Fever, EUA, COA, Medical device, Vaccine, Xpert, Cepheid variable

SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid's GeneXpert® systems. The EUA is supported by the Secretary of Health and Human Service's declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus.

Key Points: 
  • SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid's GeneXpert® systems.
  • Xpert Mpox is authorized for use in moderately complex settings and is considered authorized for use in point of care (POC) settings under the EUA for use on GeneXpert Xpress systems.
  • "Thankfully, the threat of mpox in the United States has decreased dramatically since last summer.
  • The World Health Organization recommends that suspected cases of mpox be confirmed with a PCR test run on an appropriate human lesion sample1.