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Surya Bhatt, MD: Findings on Dupilumab for Patients with COPD, Type 2 Inflammation

In this Q&A discussion, Bhatt discusses the recent news of dupilumab’s supplemental Biologics License Application for COPD patients with type 2 inflammation, as well as its significance.

Surya-bhatt , University-of-alabama-at-birmingham , Physiology-lab , Drug-administration , Division-of-pulmonary , Biologics-license-application , Critical-care-medicine , Exercise-physiology , Copd , Fda , Sbla , Bhatt

FDA Accepts sBLA for Priority Review of Dupilumab for Uncontrolled COPD

The FDA’s decision is planned for June 2024, and follows the successful results of the BOREAS and NOTUS trials.

Drug-administration , Biologics-license-application , Priority-review , Sbla , Fda , Copd , Uncontrolled , Pulmonary , Dupilumab , Dupixent ,

FDA Grants Priority Review to Adjuvant Alectinib for Early-Stage ALK+ NSCLC

The FDA granted priority review to a sBLA seeking the approval of alectinib as adjuvant treatment after surgery for early-stage ALK-positive NSCLC.

Nsclc , Non-small-cell-lung-cancer- , Alk-positive-non-small-cell-lung-cancer- , Sbla , Priority-review- , Alectinib- , Alecensa , Phase-3-alina-study- , Nct03456076 , Adjuvant-treatment-after-surgery- ,

Australian businesses to pull back on borrowing and investing in 2024 – survey

Medium-sized businesses are more likely to tighten their budgets

Australia , Australian , Small-business-loans-australia , Alon-rajic , Small-business-loans , South-australia , Sbla , Mes , Urvey ,

AZ gets CRL asking for REMS changes to rare disease sBLA

While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.

Astrazeneca-rare-disease , Ultomiri-risk-evaluation , Mitigation-strategy , Astrazeneca-plc , Alexion , Strazeneca-rare-disease , Sbla , Ultomiris , Ravulizumab , Neuromyelitis-optica-spectrum-disorder , Rems

Detailed text transcripts for TV channel - CNN - 20170916:02:59:00

now i understand why north koreans are visibly emotional when they come here. mt. paektu symbolizes their achievements. >> nice to meet. >> after more than a dozen trips to north korea i can't help but believe at heart we share the same hopes, the same struggles, for food, and shelter, for safety and security. to learn. and to live. sbla. >> what i wonder, is it all at the risk. on september 3rd, north korea tested its most powerful nuclear weapon ever. >> north korea will be met with fire and fury. >> american officials responded with words of war.

North-korea , Achievements , Paektu , Nice , Help , Food , Security , Trips , Heart , Hopes , Struggles , Shelter