About 141,898 results

Ribociclib/Everolimus Elicits Responses in Dedifferentiated Liposarcoma

Dec 4th, 2021 - The combination of ribociclib (Kisqali) and everolimus (Afinitor) elicits responses in patients with advanced dedifferentiated liposarcoma (DDLPS) and offers a tolerable safety profile, according to Margaret von Mehren, MD, who added that these responses have not previously been seen in this patient population with CDK4 inhibitors. The phase 2 SAR-096 trial (NCT03114527) met its primary end ...

FDA Grants Priority Review to Luspatercept-aamt for Non–Transfusion Dependent Beta Thalassemia

Dec 3rd, 2021 - The FDA has granted priority review to the supplemental biologics license application (sBLA) for luspatercept-aamt (Reblozyl) for the treatment of anemia in adults with non–transfusion dependent (NTD) β-thalassemia. The European Medicines Agency has also validated the Type II variation for the agent’s use in the same indication.1 The applications were supported by safety and efficacy data yiel...

Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests ...
MedWatch; FDA

Dec 3rd, 2021 - UPDATE: For additional information on the impact of SARS-CoV-2 viral mutations, including the latest list of authorized tests whose performance could be impacted by SARS-CoV-2 viral mutations, see SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S....

Clinical Edge Journal Scan Commentary: COVID-19 December 2021
Nahid Bhadelia, MD, MALD

Dec 3rd, 2021 - Nahid Bhadelia, MD, MALD COVID-19 outcomes for specific populations as well as utility of therapeutics remain important research questions. A study in Lancet HIV, examined outcomes specifically for HIV positive individuals compared to their seronegative counterparts.

Brexucabtagene Autoleucel Expands Treatment Possibilities in ALL

Dec 3rd, 2021 - Based on data from the phase 1/2 ZUMA-3 trial (NCT02614066), the FDA has approved the CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy brexucabtagene autoleucel (Tecartus) for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). In 54 evaluable patients, 51.9% (95% CI, 37.8%-65.7%) achieved complete remission (CR) within 3...

Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thro...
MedWatch; FDA

Dec 3rd, 2021 - The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The Arrow-Trerotola Over-The-Wire (PTD) Kit Percutaneous Thrombolytic Device: 7FR includes a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow-Trerotola Percutaneous Thrombolyic Device (PTD) Catheter is used ...

Rheumatoid Arthritis Highlights From ACR 2021
Stanley B. Cohen, MD

Dec 3rd, 2021 - Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021.

De-Escalated Approaches Continue to Show Benefit in HER2+ Breast Cancer

Dec 2nd, 2021 - The shift away from chemotherapy as a standard treatment for patients with HER2-positive breast has continued with the incorporation of de-escalated therapies into the treatment paradigm, according to Deborah L. Toppmeyer, MD. Allowing patients to avoid potential adverse events associated with chemotherapy has been a key benefit of expanded treatment options, Toppmeyer said. She added that the...

Metastatic Cervical Cancer: ADC Adverse Event Management

Dec 2nd, 2021 - Transcript: Bradley Monk, MD, FACOG, FACS: Warner, let’s discuss your study. You told us about the efficacy, and I told you what the median survival was. Please talk about the adverse reactions associated with tisotumab vedotin? Warner K. Huh, MD, FACOG, FACS: Overall it was generally well tolerated. One thing we observed about ADCs [antibody-drug conjugates], particularly with this ADC, is...

How Well Do COVID Vaccines Mix and Match Together?

Dec 2nd, 2021 - A "mix and match" booster strategy with a variety of different COVID-19 vaccines was safe and boosted immune response following primary series vaccinations with either Pfizer or AstraZeneca's shots, U.K. researchers found. In addition to Pfizer and AstraZeneca, the study found acceptable immune responses and safety profiles among five other vaccines when used as boosters after the two-dose Pfiz...

Bevacizumab Add-On No Help in Progressive EGFR-Mutant Lung Cancer

Dec 2nd, 2021 - Adding the angiogenesis inhibitor bevacizumab (Avastin) to osimertinib (Tagrisso) failed to slow progression of advanced EGFR-mutant non-small-cell lung cancer (NSCLC) that had progressed on prior anti-EGFR therapy, a randomized trial showed. Median progression-free survival (PFS) increased from 12.3 months with osimertinib alone to 15.4 months with the combination, but the difference did not a...

New Type of Hepatitis B Vaccine OK'd

Dec 2nd, 2021 - The FDA approved the first three-antigen hepatitis B vaccine (PreHevbrio) to prevent infection from all known subtypes in adults, VBI Vaccines announced on Wednesday. Approval for the recombinant vaccine -- which contains the S, pre-S1, and pre-S2 hepatitis B virus (HBV) surface antigens -- was based on data from two phase III trials that compared the safety and immunogenicity against the singl...

Year in Review: Bipolar Disorder and Schizophrenia

Dec 2nd, 2021 - The limits of psychiatry have been tested over 2021 amidst the mental health fallout of the COVID-19 pandemic. Grim reports have detailed the uptick in people struggling with mental health and higher COVID-related mortality rates among these individuals, especially for those with schizophrenia or bipolar disorder. But 2021 also saw key developments in therapeutic developments and treatment appr...

SGLT2 inhibitor use tied to fewer atrial arrhythmias
Mitchel L. Zoler, PhD

Dec 2nd, 2021 - Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years. Dr.

Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40...
MedWatch; FDA

Dec 2nd, 2021 - FOR IMMEDIATE RELEASE – December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months...

Pfizer and Moderna Vaccines Face Off Again

Dec 2nd, 2021 - While risk of COVID-19 infection was lower among veterans vaccinated with Moderna compared with Pfizer, both vaccines were associated with low risk, researchers found. During the period of the Alpha variant, the estimated risk of documented infection was 5.75 events per 1,000 persons (95% CI 5.39-6.23) in the Pfizer group and 4.52 events per 1,000 (95% CI 4.17-4.84) in the Moderna group, report...

Clinical Edge Journal Scan Commentary: Uterine Fibroids December 2021
Mindy S. Christianson, MD

Dec 1st, 2021 - Mindy S. Christianson, M.

Therapeutic Frontiers for Relapsed/Refractory Multiple Myeloma Expand With CAR T and Bispecific Antibodies

Dec 1st, 2021 - Multiple Myeloma is a clonal plasma cell neoplasm characterized by bone lesions, renal impairment, cytopenias, and immunodeficiency. Despite significant therapeutic advancements in the past 2 decades that have resulted in improved survival, myeloma remains an incurable disease. The immune environment in which the cancer cells thrive is known to be a key player in the evolution of monoclonal gam...

Biologics vs Small Molecule Drugs for UC: Which Agent Emerged on Top?

Dec 1st, 2021 - One Janus kinase (JAK) inhibitor was significantly superior to all other agents for inducing clinical remission in patients with moderate-to-severe ulcerative colitis (UC), but also ranked highest for adverse events, a network meta-analysis suggested. In a comparative analysis of 29 studies, upadacitinib (Rinvoq) was significantly superior for inducing clinical remission and endoscopic improvem...

Immunotherapy Shows Promise for Difficult-to-Treat HRP Ovarian Cancer

Dec 1st, 2021 - A novel immunotherapy provided durable disease control in homologous repair proficient (HRP) ovarian cancer, subgroup data from a small randomized trial showed. After 3 years of follow-up, median overall survival (OS) had yet to be reached in patients who received gemogenovatucel-T (Vigil), but appeared to exceed 41 months, as compared with a median OS of 26.9 months for placebo-treated patient...