Columbus, OH

The FDA on Monday signed off on Liquidia Corporation’s Yutrepia (nebulized treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. However, the regulator’s tentative approval means that Yutrepia cannot yet enter the U.S. market—despite meeting all regulatory standards of safety, quality and efficacy.

Liquidia Misses Full Approval for Pulmonary Hypertension Drug as Competitor Retains Market Exclusivity

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 US label for lenvatinib has been updated to include new clinical efficacy data for its use as a first-line treatment in advanced non-clear cell renal cell carcinoma, based on results from the KEYNOTE-B61 trial. The label for lenvatinib (Lenvima), an orally available multiple receptor tyrosine kinase inhibitor (TKI), has...

Lenvatinib Gets Updated Label to Include First-Line Efficacy in Advanced nccRCC

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

Belzutifan improved PFS and objective response compared with everolimus for patients with advanced renal cell carcinoma. Rates of treatment-related grade 3 or higher adverse events appeared similar in each group. Belzutifan significantly improved PFS and objective response compared with everolimus for patients with advanced renal cell carcinoma, according to results...

Belzutifan improves PFS, response in advanced renal cell carcinoma

Researchers have demonstrated that adding metastasis-directed radiation therapy to standard-of-care chemotherapy may improve progression-free survival in patients with oligometastatic pancreatic cancer, according to a recent study published by Ludmir et al in the Journal of Clinical Oncology and previously presented at the 2024 ASCO Gastrointestinal Cancers Symposium (Abstract 603). Background.

Metastasis-Directed Radiation Therapy Plus Chemotherapy in Oligometastatic Pancreatic Cancer

In August 2024, the FDA approved six new cancer treatments, including some that haven’t previously been approved. During the summer of 2024, the Food and Drug Administration (FDA) approved a handful of cancer treatments for patients with both solid and blood cancers. In August, the agency approved six more treatments, ranging from non-small cell lung cancer (NSCLC) to relapsed or refractory cutaneous T-cell lymphoma.

6 FDA Cancer Approvals from August 2024

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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

Acute Monoblastic Leukemia is a rare but aggressive type of cancer affecting the blood and bone marrow. It primarily involves monoblasts, which are immature white blood cells. This disease progresses rapidly, requiring prompt diagnosis and treatment. Symptoms often include fatigue, fever, and frequent infections. Risk factors can range from genetic predispositions to previous chemotherapy treatments. Understanding this condition is crucial for early intervention and better outcomes. In this post, we'll explore 20 essential facts about Acute Monoblastic Leukemia, shedding light on its causes, symptoms, treatments, and more. Stay informed to better recognize and combat this challenging disease.

20 Facts About Acute Monoblastic Leukemia

First-line amivantamab plus lazertinib has been approved by the FDA for locally advanced or metastatic EGFR-mutated non–small cell lung cancer. The FDA approved first-linen amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) to treat adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.1.

First-Line Amivantamab Plus Lazertinib Receives FDA Approval for EGFR-Positive Advanced NSCLC

Colorado State

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Aurora, CO

David Heitz

The Aurora Police Department released a statement on Tuesday on social media to clear up misinformation about an incident involving thousands of migrants. “Misinformation has spread on social media regarding the large gathering on Sunday at Gardens on Havana shopping center,” Aurora PD posted on X. “We recognize that Sunday’s incident was disconcerting and alarming for a large number of our residents and citizens. The purpose of this message is to provide the community with accurate information based on what we know right now.”

Law-abiding Venezuelans watch election results in Aurora, leave behind mess

Two separate clinical trials have found that a class of drugs that stymie inflammation may improve the effectiveness of commonly used immunotherapies. In both trials—one involving people with lung cancer and the other with lymphoma—adding a JAK inhibitor to an immune checkpoint inhibitor shrank tumors in more than half of the participants.

Drug Combo JAKs Up Immunotherapy in Two Clinical Trials

Cancer Health

In 2006, Diana Lindsay, who had never so much as held a cigarette, was diagnosed with stage 4 lung cancer. It had metastasized to both lungs, her brain and lymph nodes. Keith Eaton, MD, PhD, clinical director of thoracic, head and neck medical oncology at Fred Hutch Cancer Center, told her that a typical patient in this situation would have about nine months to live. But he also observed that she seemed remarkably strong and vital. “He said, ‘You don’t look like my normal lung cancer patient,’” said Lindsay, who had just returned from a business trip to Europe. She was 54 at the time. “He didn’t want to take away the health I had for the limited time I had to live.”

20 Years Since an EGFR Discovery, a Woman With Stage IV Lung Cancer Is Thriving

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study. The European Medicines Agency (EMA) has validated a Type II variation application that expands the indication for Breyanzi, a Bristol Myers Squibb product, to include treatment of adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy (1). The validation, which confirms the completion of the therapy’s submission to EMA and allows scientific review to begin, was announced by Bristol Myers Squibb in a press release on Aug. 19, 2024.

Bristol Myers Squibb Follicular Lymphoma Therapy Gets Expanded EMA Indication

A bill quietly introduced this spring in the Colorado legislature to decriminalize the possession of drug paraphernalia obtained by harm reductionists has become law. As low-key as the legislation was introduced, the bill was signed into law without fanfare June 6. It garnered little to no media attention.

Colorado legalizes needles, pipes for meth and crack if obtained by harm reduction group

Mild-to-moderate IPF may cause adaptive changes in feeding that are closely linked to nutritional status, lung function, and the severity of dyspnea. Swallowing is an intricate process that necessitates the coordinated activity of muscles in the mouth, pharynx, larynx, and esophagus, explained a study published online in BMC Pulmonary Medicine. Dysphagia, a condition marked by difficulty swallowing, can significantly exacerbate respiratory diseases by potentially increasing lung disease exacerbations and hastening the decline in pulmonary function. This study sought to examine swallowing dynamics in patients with idiopathic pulmonary fibrosis (IPF) and its association with tongue pressure, pulmonary function, and overall health status.

Addressing the Knowledge Gap: Idiopathic Pulmonary Fibrosis and Swallowing

Denver, CO

The Denver City Council accepted Monday two grants totaling $24.5 million from the state of Colorado to pay for the homeless navigation campus it opened last year. One council member wants answers as to why wraparound services at the campus aren't up and running.

Denver homeless hotel wins $24.5 million grant, experiences wraparound services delay

Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs. Amneal Pharmaceuticals Inc. announced yesterday the FDA approval for Parkinson’s drug Crexont (carbidopa and levodopa) via a news release on their website. This novel medication, formerly known as IPX203, combines two common drugs into one capsule.

FDA Approval Granted for Novel Parkinson’s Treatment

Georgia State

The Current GA

A state Supreme Court’s decision reversing a lower court’s ruling that a private contractor was exempt from the Georgia Open Records Act is being hailed as a win for open government.

State Supreme Court rules Open Records Act applies to private contractors working for governments

GDANSK (Reuters) - BioNTech on Monday said the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on an early stage study of its experimental cancer drug.

BioNTech says FDA lifts partial hold on its cancer drug trial

NewsBreak

FDA Accepts Nivolumab/Ipilimumab Application for First-Line HCC Treatment

The application is supported by the phase 3 CheckMate -9DW study, and the FDA has set a target action date of April 21, 2025. The FDA...

FDA Accepts Nivolumab/Ipilimumab Application for First-Line HCC Treatment

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