Columbus, OH

Reuters

(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge for AstraZeneca's blockbuster drug Tagrisso.

J&J's chemotherapy-free treatment for lung cancer gets US approval

Approved a new initial treatment for advanced non-small-cell lung cancer after clinical trials showed patients lived longer without disease progression, compared to the standard treatment currently used. The chemotherapy-free combination involves two drugs, one of which has never been approved for use in the U.S. called lazertinib, which will be...

FDA Approves New Treatment for Non-Small-Cell Lung Cancer

The FDA has cleared its first automated insulin pump for adults with Type 2 diabetes, with Insulet’s Omnipod 5 delivery system opening the door to a population of more than 6 million people. That includes about 2.5 million people who require multiple injections of insulin per day, according to...

FDA clears its first automated insulin pump for Type 2 diabetes with Insulet's Omnipod 5

BGB-16673 has received FDA fast track designation for relapsed or refractory CLL or SLL following 2 or more prior lines of therapy. The FDA has granted fast track designation to BGB-16673 for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received 2 or more prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.1.

FDA Grants Fast Track Designation to BGB-16673 in Previously Treated CLL/SLL

New data on zongertinib for HER2-positive non–small cell lung cancer will be presented at the IASLC 2024 World Conference on Lung Cancer, shedding light on its potential as a novel treatment option for this patient population. Zongertinib (BI 1810631), an investigational oral therapy, was granted breakthrough therapy designation (BTD)...

FDA Grants Zongertinib Breakthrough Therapy Designation in HER2-Mutant NSCLC

The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects in the knee. The FDA has approved Vericel Corporation’s MACI for repairing cartilage defects in the knee. According to the company, MACI uses a patient’s own cells cultured on a porcine collagen membrane. This method, also known as MACI Arthro, can be administered through small incisions using custom instruments, providing a substantial improvement in full-thickness cartilage defects up to 4 cm² in size, offering a less invasive option, according to the company.1.

FDA Approves Arthroscopic Delivery of Vericel’s MACI for Knee Cartilage Defects

A dose of Pfizer’s RSV vaccine was safe and generated a strong response in immunocompromised adults aged younger than 59 years. RSV vaccines have not been recommended for anybody aged younger than 60 years. A dose of Pfizer’s respiratory syncytial virus vaccine was well tolerated and generated a strong...

Pfizer: RSV vaccine generates strong response in immunocompromised adults

Solly Chedid, MD, provides clinical insights on quality-of-life assessment practices for patients with MDS. Case: Frontline Use of Erythroid Maturating Agent (EMA): Luspatercept. Clinical Presentation:. 70-year-old man diagnosed 6 months ago with LR-MDS with multilineage dysplasia - moderate anemia (Hb 11.2) and thrombocytosis (PLT 500,000 μl) SF3B1 mutation positive.

Assessing QoL in MDS Patients

Melbourne, FL

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Akeena

A Burger King location in Melbourne, Florida, has been temporarily shut down for the third time following since 2023 after a recent state inspection that identified multiple health violations. This incident underscores ongoing concerns regarding the restaurant's adherence to health and safety standards.

A dead lizard, dead roaches, rodent droppings - Florida fast food restaurant closed again

Aortic valve stenosis is a condition where the heart's aortic valve narrows, making it hard for blood to flow from the heart to the rest of the body. This can lead to serious health issues if not treated. Symptoms often include chest pain, fatigue, and shortness of breath. Causes range from congenital heart defects to age-related calcification. Diagnosis typically involves echocardiograms and other imaging tests. Treatment options vary from medication to surgical procedures like valve replacement. Understanding this condition is crucial for managing it effectively. Here are 45 facts to help you get a better grasp of aortic valve stenosis.

45 Facts About Aortic Valve Stenosis

Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis. The Cambridge-based company Microbiotica announced today that it has received approvals to initiate clinical trials in some EU countries and the UK for...

EU and UK approve Microbiome Medicines for advanced melanoma and ulcerative colitis

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy. Tel Aviv-based RedHill Biopharma has been given orphan drug designation by FDA for Opaganib, a proprietary and investigational host-directed drug for treatment of neuroblastoma, a type of cancer that is the most common malignancy among infants, with a median age of 17 months at the time of diagnosis (1). RedHill announced the FDA decision in a press release on Aug. 26, 2024.

RedHill Granted FDA Orphan Drug Designation for Neuroblastoma Treatment

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community_voice

The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

FDA expands Omnipod 5 AID system for type 2 diabetes, marking the first AID system approved for both type 1 and type 2 diabetes management. The US Food and Drug Administration (FDA) has announced the expansion of indications for Insulet Corporation’s SmartAdjust technology, clearing the way for use of the Omnipod 5 Automated Insulin Delivery (AID) System in adults with type 2 diabetes.1.

FDA Clears Omnipod 5 AID System for Type 2 Diabetes

Massachusetts State

Camilo Díaz

(MA) Meet Apple, a pocket-sized Chihuahua mix girl who is ready to dive into your heart, home, and bed. This 10-week-old puppy was placed in Great Dog Rescue New England's care for unspecified reasons. She is currently living safely with a foster family while she awaits her future home. Since she is still such a young puppy, she is okay with waiting a while for the perfect family to come and get her. But don't make her wait too long!

Tiny 5-Pound Chihuahua Is Searching For A Home

Genome Medicine volume 16, Article number: 107 (2024) Cite this article. Poly (ADP-ribose) polymerase 1 and 2 (PARP1/2) inhibitors (PARPi) are targeted therapies approved for homologous recombination repair (HRR)-deficient breast, ovarian, pancreatic, and prostate cancers. Since inhibition of PARP1 is sufficient to cause synthetic lethality in tumors with homologous recombination deficiency (HRD), PARP1 selective inhibitors such as saruparib (AZD5305) are being developed. It is expected that selective PARP1 inhibition leads to a safer profile that facilitates its combination with other DNA damage repair inhibitors. Here, we aimed to characterize the antitumor activity of AZD5305 in patient-derived preclinical models compared to the first-generation PARP1/2 inhibitor olaparib and to identify mechanisms of resistance.

The PARP1 selective inhibitor saruparib (AZD5305) elicits potent and durable antitumor activity in patient-derived BRCA1/2-associated cancer models

Georgia State

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Daily Coffee Press

According to officials with the Southern District of Georgia, two recently unsealed federal indictments have charged 23 defendants in a series of broad conspiracies involving the use of drones to smuggle methamphetamine, marijuana, and cell phones into state prisons in Georgia.

23 Defendants Charged in Federal Indictments for Drone-Smuggling Drug Operation in Georgia

IMU-838 daily doses of 30-mg and 45-mg suppressed the development of gadolinium-enhancing lesions by 78% and 74% compared with the placebo at 24 weeks in relapsing-remitting multiple sclerosis. New data from the phase 2 EMPhASIS trial (NCT03846219) published in Neurology Neuroimmunology & Neuroinflammation showed that vidofludimus calcium formulation (IMU-838) given...

IMU-838 Shows Reduction of Brain Lesions in Phase 2 EMPhASIS Trial for Relapsing-Remitting Multiple Sclerosis

Improvements in multiplex immunofluorescence and spatial analysis have enabled a better understanding of the ways classical Hodgkin lymphoma evades the immune system. A new multiplex spatial analysis of cases of classical Hodgkin lymphoma (cHL) suggests increased expression of CD137 is correlated with refractory disease. The report also links monocytic myeloid-derived suppressor cells (m-MDSCs) with a poor prognosis.1 The study was published in OncoImmunology.

Multiplex Spatial Analysis Highlights Mechanisms of Refractory cHL

Florida State

Jacksonville, FL

Jacksonville Today

Jacksonville Sheriff T.K. Waters said he will consider more DUI patrols if voters legalize recreational marijuana use in Florida. Voters will consider Amendment 3 in November. It would allow adults 21 or older to possess, purchase or use marijuana products and marijuana accessories for non-medical purposes.

More DUI patrols possible if marijuana issue passes

NewsBreak

The Targeted Pulse: T-Dxd Received FDA Breakthrough Therapy Designation, Real-World Data Confirms Brexu-cel’s Impact, and More

T-DXd receives FDA breakthrough therapy designation for HR+/HER2-low breast cancer and real-world data confirms brexu-cel’s efficacy in relapsed/refractory B-cell ALL. A New AI-based study enrolls first...

The Targeted Pulse: T-Dxd Received FDA Breakthrough Therapy Designation, Real-World Data Confirms Brexu-cel’s Impact, and More

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