Moderna Announces Good Results From Trial of Combo COVID/Flu Vaccine

Medically reviewed by Drugs.com.
By Ernie Mundell HealthDay Reporter

An experimental vaccine that could offer one-stop prevention for both COVID-19 and influenza is showing positive results among older adults in trials, maker Moderna announced Monday.

The shot — for now called mRNA-1083 — “has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial,” Moderna said.

The dual-purpose shot, won’t be okayed in time for this years’ flu season.

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FDA Gives Nod to RSV Vaccine for People in Their 50s

Medically reviewed by Drugs.com.
By Ernie Mundell HealthDay Reporter

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

  • Drugmaker GSK’s Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already
    approved for use in adults 60 and older, since age brings higher risk from RSV disease.
  • Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

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HomeoCare Laboratories Inc. Issues Recall of Stella Life Oral Care Spray Unflavoredand Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination

HomeoCare Laboratories Inc. is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level

Risk Statement: The following two (2) products listed below were found to contain higher than acceptable levels of TAMC (found in the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse) and Bacillus sp (found in the StellaLife Vega Oral Spray, Unflavored).

Production
Date
Release
Date
CustomersProduct NameNDCLot
No.
Expiration
Date
02/16/202403/28/2024StellaLife
Inc.
StellaLife VEGA Oral
Care, Spray Unflavored
69685-
121-01
255202/2026
Production
Date
Release
Date
CustomersProduct NameNDC
Lot
No.
Expiration
Date
03/01/202403/28/2024StellaLife
Inc.
StellaLife Advanced
Formula Peppermint
VEGA Oral Care Rinse
69685-
143-16
255002/2026

Source: FDA

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RYTELO™

FDA Approves Rytelo for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia June 6, 2024 – Geron Corporation has announced that the U.S. Food and Drug Administration (FDA) has  approved Rytelo™ (imetelstat) for the treatment of adult patients:

• with low- to intermediate-1 risk myelodysplastic syndromes (MDS),

• with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks,

• who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity, and It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Source: Geron Corporation

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Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection,USP Due to Potential Presence of Particulate Matter

Sagent Pharmaceuticals has announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80mg per 8mL multi-dose vials and 160mg per 16mL multi-dose vials). The product was distributed by Sagent Pharmaceutical, and the company has initiated a voluntary recall.

The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.

ProductLot NumberNDCExpiration DateStrength
DOCETAXEL
INJECTION, USP
F103000125021-254-1612/2024160mg/16mL
(10mg/mL)
F104000125021-254-0812/202480mg/8mL
(10mg/mL)

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