Columbus, OH

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

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

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

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 patient, strengths and weakness in multiple myeloma treatment are examined, and tafasitamab combination scores in FL. Want to test your knowledge on the...

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

BGB-16673 has been granted FDA fast track designation based on findings from a phase 1/2 study of the oral agent in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA has granted fast track designation to BGB-16673 for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic...

Novel BTK Degrader Earns FDA Fast Track Designation in CLL/SLL

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NewsNinja

An Aldi shopper recently shared her disturbing experience with a moldy rice package from the supermarket, sparking debate. A TikTok user named @defonotlils posted a video on June 6 that quickly became popular, accumulating more than 674,600 views. In the video, she shares what happened after finding out about something.

This is why I don’t shop at Aldi: Woman can’t believe what she found in her packaged rice from Aldi

Recent advances in the field of microbiome research have provided valuable insights into the complex relationship between gut health and various neurological conditions, including autism. A groundbreaking study published in Nature Microbiology has expanded our understanding of this relationship by exploring the roles of not just gut bacteria but also fungi, archaea, and viruses.

Gut Microbiome in Autism Spectrum Disorder

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments. In a report published last week...

FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

Coffee County, GA

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

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Daily Coffee Press

Last week, two individuals from Coffee County were charged with trafficking methamphetamine following a search at a residence on Willacoochee Highway. On August 13, detectives with the Coffee County Drug Unit conducted an operation involving Charles Black, which led to a search of his residence on Willacoochee Highway. According to the report, Black left his residence before the warrant was served and was subsequently detained.

Two Charged with Trafficking Methamphetamine After Search in Coffee County

Alzheimer’s disease research and drug development is evolving at a rapid pace. Decades of research has led to the approval of the first disease-modifying drugs and new pathological discoveries. The first blood-based biomarker tests will bring equitable access to screening and diagnosis while accelerating clinical research. These major breakthroughs in the last few years alone represent a pivotal time in the Alzheimer’s disease landscape.

The Evolving Alzheimer’s Disease Landscape

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

The Independent

 The UK’s medicines regulator is set to approve a drug that has been shown to slow the progression of Alzheimer’s disease.Lecanemab, developed by pharmaceutical company Eisai, is a targeted antibody treatment that binds to amyloid, a protein which builds up in the brains of people living with Alzheimer’s disease.It is designed to help clear the build-up and slow down cognitive decline in people with the condition and is given to patients via an intravenous drip fortnightly.The decision from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to be announced shortly, but it is understood to have approved the...

Medicines regulator set to give Alzheimer’s drug green light

Saint Louis, MO

People with multiple sclerosis (MS) are far less likely than those without the condition to have the molecular hallmarks of Alzheimer’s disease, according to new research from Washington University School of Medicine in St. Louis. The discovery suggests a new avenue of research through which to seek Alzheimer’s treatments,...

Multiple sclerosis appears to protect against Alzheimer’s disease

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

Pelage Pharmaceuticals, a clinical-stage regenerative medicine company, has initiated its Phase 2a trial for PP405, a topical small molecule designed to treat androgenetic alopecia. The study will evaluate safety and efficacy in 60 diverse participants, including both women and men. The company has secured $14 million in Series A-1 financing, led by GV, following positive Phase 1 results. This funding will accelerate the clinical program for this innovative hair loss treatment.

Regenerative Hair Loss Treatment Targets Dormant Follicle Stem Cells [Clinical Trial]

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

Georgia State

Appling County, GA

A 40-year-old man from Appling County, Christopher Eric Stone, with a significant criminal history, was recently sentenced to over five years in prison after pleading guilty to possession of methamphetamine with intent to distribute, according to officials from the Department of Justice.

Georgia Man Sentenced to Over 5 Years for in Federal Prison for Meth Distribution

A collaborative study conducted by Duke-NUS and the NUS Mechanobiology Institute brings new hope for treating neurodevelopmental disorders by reactivating dormant neural stem cells and revealing additional mechanisms involved in brain development. Researchers at Duke-NUS Medical School and the Mechanobiology Institute at the National University of Singapore have identified a...

Breakthrough Discovery Awakens Dormant Brain Cells, Offering New Hope for Autism and Cerebral Palsy

Ozempic and Wegovy may have some new competition. Eli Lilly has announced that its new diabetes drug, Zepbound (tirzepatide), reduced the risk of developing Type 2 diabetes by 94% in prediabetic adults in a clinical trial. Additionally, treatment with tirzepatide resulted in sustained weight loss through the treatment period, with...

Eli Lilly says its new diabetes drug was 94% effective in clinical trials

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

NewsBreak

INV724 Earns FDA Orphan Drug and Rare Pediatric Drug Designations in Neuroblastoma

The innovative bispecific antibody INV724 targets GD2 and B7-H3 with high specificity for neuroblastoma. The FDA has granted rare pediatric disease designation (RPDD) and orphan drug...

INV724 Earns FDA Orphan Drug and Rare Pediatric Drug Designations in Neuroblastoma

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