Posts in category: Uncategorized

Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples.

There have been no complaints or reports of injuries or deaths.

Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years. This approval is based on data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device (IUD or IUS) in the U.S. Originally approved by the FDA on February 26, 2015, Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to eight years.

• Read more… FDA Approves Medicines360’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years

Manufacturer ImmunoGen, Inc., has announced that Elahere™ (mirvetuximab soravtansine-gynx) has been approved as a folate receptor alpha (FRα)-directed antibody and microtubule 4 Drug News – Volume 9, Issue 12 inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

• Elahere is an intravenous infusion administered once every 3 weeks (21-day cycle). Dosage is based on each patient’s ideal body weight.
• ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
• It is not known if this medicine is safe and effective in children. • Read more… https://www.drugs.com/pro/elahere-injection.html#s-43685

Seagen Inc. (Nasdaq: SGEN) has announced that the U.S. Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Originally approved by the FDA on August 19, 2011, Adcetris (brentuximab vedotin) injection is a CD30directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and mycosis fungoides. 5 Drug News – Volume 9, Issue 12

• Read more… Seagen Announces U.S. FDA Approval of New Indication for Adcetris (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology. Originally approved by the FDA on September 28, 2018, Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

• Read more… Libtayo (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)

GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has approved an oral-dosing applicator-only presentation (liquid formulation) of Rotarix (Rotavirus Vaccine, Live, Oral), which prevents rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4 and G9) in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare Rotarix by removing the need to reconstitute the vaccine dose at the point of use. 6 Drug News – Volume 9, Issue 12 Originally approved by the FDA on April 3, 2008, Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.

• Read more… FDA Approves New Fully Liquid Presentation of GSK’s Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi- cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.

AstraZeneca’s Imjudo (tremelimumab), in combination with Imfinzi (durvalumab), has been approved by the FDA for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the combination, which includes a single dose of the anti-CTLA-4 antibody Imjudo 300mg added to the anti- PD-L1 antibody Imfinzi 1500mg followed by Imfinzi every four weeks is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the HIMALAYA Phase III trial. In this trial, patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death versus sorafenib. Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.

AbbVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of Rinvoq in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions. Originally approval by the FDA on August 16, 2019, Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

• Read more… Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active NonRadiographic Axial Spondyloarthritis

The U.S. Food and Drug Administration (FDA) approved an expansion of the indication for Eli Lilly and Company’s rapid-acting mealtime insulin Lyumjev® (insulin lispro-aabc) injection to include the improvement of glycemic control in children with diabetes. Lyumjev can be administered subcutaneously either at the start of a meal or within 20 minutes after starting a meal, or as a continuous subcutaneous insulin infusion (CSII) with an insulin pump. Originally approval by the FDA on June 15, 2020, Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

• Read more… Lyumjev (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes