Influenza

Dyadic Announces Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, August 9, 2023

The Last Patient Last Visit (LPLV) is scheduled for August 25, 2023, and the full clinical study report (CSR) is expected in Q4 2023.

Key Points: 
  • The Last Patient Last Visit (LPLV) is scheduled for August 25, 2023, and the full clinical study report (CSR) is expected in Q4 2023.
  • Uvax Bio (“Uvax”) – In June 2023, the Company has renewed and expanded its research collaboration with Uvax, a spin-off vaccine company from Scripps Research.
  • NIIMBL – During the NIIMBL annual meeting in June 2023, the Company presented data and research results generated from the NIIMBL Grant received by the Company under the previously announced White House’s American Rescue Plan, which ended successfully.
  • New Animal Health Partner – In June 2023, the Company entered a fully funded collaboration with a new animal health company to develop an antigen for livestock animals.

Cue Health Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023

Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.

Key Points: 
  • Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.
  • Submitted the Cue RSV Molecular Test as a De Novo submission to the FDA for at-home and point-of-care use during the second quarter.
  • These milestones, together with the early positive signs we’re seeing from Cue Lab and Cue Pharmacy, gives us optimism and confidence in the future of the Cue Health platform.”
    Revenue was $9.9 million for the second quarter of 2023.
  • GAAP net loss in second quarter of 2023 was $83.9 million and earnings per diluted share was a loss of $0.55 or an improvement of $0.12 from the second quarter of 2022.

Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use

Retrieved on: 
Thursday, August 3, 2023

The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.

Key Points: 
  • The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.
  • Cue also requested De Novo classification from the FDA for the Cue RSV Molecular Test for at-home and point-of-care use.
  • Cue also recently received De Novo authorization from the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test), which was the first De Novo granted for any home use respiratory test available without a prescription.
  • The Cue molecular tests all run on the Cue Health Monitoring System (Reader), which has an installed base of more than a quarter million.

Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023

SAN DIEGO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2023 and provided an update on its corporate activities and product pipeline.

Key Points: 
  • SAN DIEGO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2023 and provided an update on its corporate activities and product pipeline.
  • “This quarter we made important progress in the advancement of our Cloudbreak® drug-Fc conjugate (DFC) platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • Final results of the Phase 2a study are expected later in 2023.
  • However, Janssen has not informed Cidara of any intention to terminate the collaboration agreement between the two parties.

Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023

ET, Aug. 3, 2023 –

Key Points: 
  • ET, Aug. 3, 2023 –
    SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2023.
  • Vir expects the Phase 1 trial for VIR-1388, a novel T cell vaccine for the prevention of HIV, to begin dosing in Q3 2023.
  • In June, Sasha Damouni Ellis joined Vir as Executive Vice President and Chief Corporate Affairs Officer.
  • Revenues: Total revenues for the quarter ended June 30, 2023, were $3.8 million compared to $(40.6) million for the same period in 2022.

BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

Retrieved on: 
Tuesday, August 1, 2023

FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

Key Points: 
  • FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
  • The BD RVP test helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly.
  • The BD Respiratory Viral Panel for BD MAX™ System was CE marked under the IVD directive 98/79/EC in May of 2022, and now with the 510(k) clearance, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, with no gaps in availability of the test.
  • The BD MAX™ open system also allows customers to leverage research use only (RUO) assays and user-defined protocols (UDP) to address emerging needs quickly.

Zuellig Pharma Singapore and GSK Establish Vaccine Distribution Hub to Improve Asia’s Access to Vaccines

Retrieved on: 
Tuesday, August 1, 2023

Under the partnership, Zuellig Pharma Singapore will provide GSK with warehousing and distribution services in cold-chain management for its vaccines.

Key Points: 
  • Under the partnership, Zuellig Pharma Singapore will provide GSK with warehousing and distribution services in cold-chain management for its vaccines.
  • The vaccine hub will also leverage Zuellig Pharma's expertise in blockchain technology for China, one of GSK's largest APAC markets.
  • Tan Yan Ann, Chief Executive, Zuellig Pharma Singapore said: "GSK has been a long-term partner of Zuellig Pharma with a strong focus on improving patients' access to healthcare.
  • The new vaccines distribution hub in Singapore will become our vaccine supply gateway into the region."

Dr. Luke Lathrop and Stacy Lathrop of Roswell Launch First Drive-Thru Medical Clinic in Georgia; SmartMED Drive-Thru is Revolutionizing the Medical Industry and the Patient Experience

Retrieved on: 
Friday, July 28, 2023

ATLANTA, July 28, 2023 /PRNewswire/ -- SmartMED Drive-Thru , a one-of-a-kind, drive-thru medical clinic in Roswell, GA is transforming how medical care is delivered and received.

Key Points: 
  • ATLANTA, July 28, 2023 /PRNewswire/ -- SmartMED Drive-Thru , a one-of-a-kind, drive-thru medical clinic in Roswell, GA is transforming how medical care is delivered and received.
  • Providing patients with quick, convenient, and compassionate care in the comfort of their own cars, SmartMED is changing medicine.
  • What started as a drive-thru Covid testing site quickly became a full-service medical practice by August of 2022.
  • Since then, all three generations have returned for treatment and now consider SmartMED their first stop when medical issues arise.

Breaking Research Sheds Light on COVID, Flu, and RSV Co-infections

Retrieved on: 
Tuesday, July 25, 2023

ANAHEIM, Calif., July 25, 2023 /PRNewswire/ -- Today, at the 2023 AACC Annual Scientific Meeting & Clinical Lab Expo, scientists will present new data about rates of co-infections with SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) in the United States, providing one of the first snapshots of the interplay among these common but potentially deadly viruses. Their work could lead to better diagnosis and patient management for all three illnesses.

Key Points: 
  • The findings could have implications for how clinicians approach respiratory disease testing during future epidemics and seasonal outbreaks.
  • Household respiratory viruses such as RSV pose major burdens on public health systems.
  • But researchers have lacked the data to define rates of co-infections during this outbreak of RSV, which until recently had no vaccine.
  • The scientists tested the samples for RSV, SARS-CoV-2, and influenza A/B with the Roche cobas® and Cepheid Xpert® platforms.

Cidara Therapeutics Provides Update on Status of Ongoing CD388 Influenza Program

Retrieved on: 
Thursday, July 20, 2023

As part of a recent prioritization of its R&D business, Janssen has announced its intention to discontinue internal development of the majority of its infectious disease pipeline, including JNJ-0953 (CD388).

Key Points: 
  • As part of a recent prioritization of its R&D business, Janssen has announced its intention to discontinue internal development of the majority of its infectious disease pipeline, including JNJ-0953 (CD388).
  • However, at this time, Janssen has not informed Cidara of any intention to terminate the agreement between the two parties.
  • Under the Janssen Collaboration Agreement, within 90 days after Cidara delivers the complete CD388 Phase 2a data package to Janssen (currently anticipated later this year) (the Election Period), Janssen is required to notify Cidara whether it will proceed with clinical development.
  • Should Janssen not provide an Election to Proceed within the Election Period, Cidara would have the right to terminate the agreement and retain the CD388 program, including all data and materials funded by Janssen’s investment in the program.