EUA

Clinical Laboratory Service Global Market Report 2022: Technological Advancements in The Field Of Clinical Testing Bolster Growth

Retrieved on: 
Tuesday, February 14, 2023
Ethos, Business analysis, Coronavirus, CVD, Laboratory, Clinical chemistry, Mayo Clinic, Hospital, Grady EMS, Diagnosis, PCR, Stand-alone, Human, Patient, Quest Diagnostics, Diabetes, CDC, Labcorp, USD, Application, Genetics, WHO, Death, Cardiovascular disease, Partnership, Growth, Labs, Service, Emergency Use Authorization, Prevalence, COVID-19, EUA, Pharmaceutical industry, Fine chemical

DUBLIN, Feb. 14, 2023 /PRNewswire/ -- The "Clinical Laboratory Service Market Size, Share & Trends Analysis Report by Test Type (Human & Tumor Genetics, Clinical Chemistry), by Service Provider (Standalone, Hospital-based Labs), by Application, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 14, 2023 /PRNewswire/ -- The "Clinical Laboratory Service Market Size, Share & Trends Analysis Report by Test Type (Human & Tumor Genetics, Clinical Chemistry), by Service Provider (Standalone, Hospital-based Labs), by Application, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.
  • The global clinical laboratory service market size is expected to reach USD 280.67 billion by 2030, registering a CAGR of 3.7% from 2022 to 2030.
  • Improvements in laboratory testing technology through breakthrough and incremental advances are high-impact-rendering drivers for industry growth.
  • Chapter 1 Clinical Laboratory Services Market: Methodology And Scope
    Chapter 2 Clinical Laboratory Services Market: Executive Summary
    Chapter 3 Clinical Laboratory Services Market: Industry Outlook
    Chapter 4 Clinical Laboratory Services Market: Competitive Landscape
    Chapter 5 Clinical Laboratory Services Market: Type Business Analysis
    Chapter 6 Clinical Laboratory Services Market: Service Provider Business Analysis
    Chapter 7 Clinical Laboratory Services Market: Application Business Analysis
    Chapter 8 Clinical Laboratory Services Market: Regional Business Analysis
    Chapter 9 Clinical Laboratory Services Market: Company Profiling

Deloitte's 13th Annual Pharmaceutical Innovation Report: Pharma R&D Return on Investment Falls in Post-Pandemic Market

Retrieved on: 
Monday, February 6, 2023
D, Physician, ROI, COVID-19 vaccine, Patient, Clinical trial, Research, Failure, Annual report, COVID-19, R, EUA, Fine chemical, Pharmaceutical industry, Cryptocurrency

Projected returns on investment in pharma R&D in 2022 have fallen to 1.2%, the lowest ROI observed in 13 years.

Key Points: 
  • Projected returns on investment in pharma R&D in 2022 have fallen to 1.2%, the lowest ROI observed in 13 years.
  • Deloitte's series of annual reports on " Measuring the return from pharmaceutical innovation " has provided insights into the state of biopharma R&D since 2010.
  • "Measuring the return from pharmaceutical innovation 2022," is the 13th annual report from the Deloitte Center for Health Solutions, the research arm of Deloitte's life sciences and health care practices.
  • Since 2010 Deloitte's "Measuring the return from innovation" series has tracked the projected return on investment from the late-stage pipelines from an original cohort of 12 leading global biopharma companies.

FDA Roundup: February 3, 2023

Retrieved on: 
Friday, February 3, 2023
China Biologic Products, Record, Vaccine, Human services, Food, SARS-CoV-2, Office of Inspector General, U.S. Department of Health and Human Services, Heated tobacco product, Korea Disease Control and Prevention Agency, Therapy, Hospital, Animal, Patient, FDG, Tissue, Safety, Lung, News, Letter, Risk, CDC, Radiation, Death, EUA, FDA, Dietary supplement, Neoplasm, Public, Multimedia, Artificial tears, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Cardiovascular disease, Paratriathlon, Cosmetics, Control, OTC, Tears, Pharmaceutical industry

On Thursday, the FDA alerted consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination.

Key Points: 
  • On Thursday, the FDA alerted consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination.
  • FDA also placed the manufacturer on import alert for providing an inadequate response to a records request and current good manufacturing practice violations.
  • On Wednesday, the FDA authorized for marketing the RefleXion Medical Radiotherapy System (RMRS), which combines the functionality of an emission computed tomography detection system and a linear accelerator.
  • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

Diazyme SARS-CoV-2 Neutralizing Antibody Assay Receives Emergency Use Authorization

Retrieved on: 
Tuesday, February 7, 2023
Severe acute respiratory syndrome coronavirus 2, EUA, Infection, Food, SAN, DZ, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Vaccine

SAN DIEGO, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration on December 6, 2022, for use of the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit.

Key Points: 
  • SAN DIEGO, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration on December 6, 2022, for use of the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit.
  • The test is a high throughput, fully automated assay for the qualitative detection of SARS-CoV-2 neutralizing antibodies and can produce results in 35 minutes.
  • The assay is run on the DZ-Lite 3000 Plus, Diazyme’s FDA-cleared automated analyzer.
  • “This SARS-CoV-2 Neutralizing Antibody test can help clinicians assess the adaptive immune response after infection; this is particularly important in immuno-compromised patient populations”, said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.

DEADLINE ALERT for VERU and NEO: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Monday, February 6, 2023
NeoGenomics, Abuse, Complaint, NGS, Suite, Defendant, Marcus Annius Verus Caesar, EUA, Investment, Fraud, Law, Mail, Holding company

LOS ANGELES, Feb. 06, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • LOS ANGELES, Feb. 06, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors have until the deadlines listed below to file a lead plaintiff motion.
  • Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected] .
  • The Law Offices of Frank R. Cruz, Los Angeles

VERU 3-DAY DEADLINE ALERT: Hagens Berman Encourages Veru Inc. (VERU) Investors with Significant Losses to Contact Firm’s Attorneys Before Feb. 6th Deadline in Securities Class Action

Retrieved on: 
Friday, February 3, 2023
Person, COVID 19, News, COVID, Patient, SAN, FDA, EUA, Steve Berman (lawyer), Pharmaceutical industry, Verus Pharmaceuticals

SAN FRANCISCO, Feb. 03, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Veru Inc. (NASDAQ: VERU) investors with significant losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, Feb. 03, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Veru Inc. (NASDAQ: VERU) investors with significant losses to submit your losses now .
  • VERU’s filings therefore concealed the true risks faced by the Company in gaining approval for its EUA request.
  • Investors learned the truth on Nov. 9, 2022, when Veru announced that the FDA advisory committee (“AdCom”) voted against approving sabizabulin under the agency’s EUA pathway.
  • If you invested in Veru and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman .

DEADLINE ALERT for GPS, VERU, NEO, SI: Law Offices of Howard G. Smith Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Wednesday, February 1, 2023
Telephone, NeoGenomics, Abuse, People's Law Office, NGS, Suite, Class, Old Navy, EUA, Investment, Fraud, Law, Security (finance), Risk management

BENSALEM, Pa., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • BENSALEM, Pa., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors have until the deadlines listed below to file a lead plaintiff motion.
  • Investors suffering losses on their investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in these class actions at 888-638-4847 or by email to [email protected] .
  • Law Offices of Howard G. Smith

VERU INC. (NASDAQ: VERU) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Veru Inc. (NASDAQ: VERU)

Retrieved on: 
Tuesday, January 31, 2023
Breast, Steiner, Prostate cancer, Safety, Fast Track, Trial of the century, COVID-19, The Legal 500, Fast track (FDA), Advertising, Court, Health minister, NDA, Labour government, Patient, FDA, District court, EUA, Investment, Mortality, Aerospace, Infection, Death, Prostate Cancer Foundation, News, Tobacco, Security (finance), Pharmaceutical industry, Verus Pharmaceuticals

NEW YORK, Jan. 31, 2023 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the common stock of Veru Inc. (“Veru” or the “Company”) (NASDAQ: VERU) between May 11, 2022 and November 9, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of Florida and alleges violations of the Securities Exchange Act of 1934.

Key Points: 
  • Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected] to discuss your rights.
  • The lawsuit was filed in the United States District Court for the Southern District of Florida and alleges violations of the Securities Exchange Act of 1934.
  • Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

DEADLINE ALERT for GNRC, GPS, VERU, and NEO: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Monday, January 30, 2023
NeoGenomics, Generac Holdings, Abuse, Complaint, NGS, Suite, Defendant, Marcus Annius Verus Caesar, EUA, Investment, Fraud, Law, Mail, Holding company, Risk management

LOS ANGELES, Jan. 30, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • LOS ANGELES, Jan. 30, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected] .
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • The Law Offices of Frank R. Cruz, Los Angeles

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Generac, Veru, Gap, and Singularity and Encourages Investors to Contact the Firm

Retrieved on: 
Monday, January 30, 2023
Steiner, Fast Track, COVID-19, Fast track (FDA), NDA, Defendant, FDA, Plaintiff, Aerospace, News, Standard of care, Breast, Generac Holdings, SPA, Ink, P.C, Bankruptcy, Old Navy, Death, Infection, Gap Inc., Complaint, GPS, Trial of the century, Security (finance), Market share, Gap, Principle, Electricity, Safety, Failure, NYSE, Health minister, Patient, EUA, Mortality, Form 10-Q, Maintenance, Prostate cancer, Holding company, Renewable energy, Animal, Audit, Pharmaceutical industry, Singularity, Verus Pharmaceuticals

Generac's solar offering, called the PWRcell, is a battery-based system that stores and manages electricity generated from solar panels.

Key Points: 
  • Generac's solar offering, called the PWRcell, is a battery-based system that stores and manages electricity generated from solar panels.
  • In addition, the complaint alleges that Defendants overstated the Company's earnings throughout the Class Period.
  • Throughout the Class Period, numerous consumers filed complaints with regulators, and Generac's channel partners informed the Company of the SnapRS defect.
  • As a result of Defendants misrepresentations and omissions, Generac common stock traded at artificially inflated prices during the Class Period.