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FDA Drug Approvals Q1 2024
24 Apr 2024 15:11 GMT
… Phase 3 RATIONALE 302 trial. Median overall survival (OS … INNO2VATE open-label, noninferiority trials to evaluate the safety … pemetrexed and platinum-based chemotherapy as first-line treatment … )
Tepmetko (tepotinib) – FDA grants full approval for non …
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Lantern Pharma cleared to expand lung cancer treatment trial
23 Apr 2024 11:50 GMT
… care chemotherapy regimen of pemetrexed and carboplatin.
It … chemotherapy alone are the trial’s primary objectives.
… treatment for relapsed and inoperable primary adenocarcinoma of the lung.
The drug … people across various clinical trials and has generally …
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The Butterfly Flies - Practice Changing Results of PAPILLON, First Line Chemotherapy and Amivantamab for the Treatment of NSCLC Patients with EGFR Exon 20 Insertions
23 Apr 2024 12:42 GMT
… phase 3 randomized controlled trial to compare the efficacy … New England Journal of Medicine. We here review the … (carboplatin and pemetrexed) for the first line treatment of locally advanced … While these two trials both include different drugs targeted at …
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BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer
23 Apr 2024 10:17 GMT
… pemetrexed and platinum-containing chemotherapy for the first-line treatment … Medicines Agency and the U.S. Food and Drug … 17 potentially registration-enabling trials with tislelizumab, of … approvals and commercializing pharmaceutical products and its …
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Samsung Bioepis Initiates Phase 3 Clinical Trial for Proposed Pembrolizumab Biosimilar
22 Apr 2024 16:51 GMT
… clinical trials for SB27.”1
The phase 3 clinical trial (NCT06348199 … (NSCLC). Investigators will randomize treatment 1:1 for SB27 and … weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 … and United States-sourced drugs, according to an article …
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Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan
22 Apr 2024 12:34 GMT
… could potentially transform the treatment landscape for never- … drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed … administered in multiple clinical trials to more than … the Harmonic™ clinical trial website, on ClinicalTrials.gov …
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Shilpa Medicare marketing partner unveils Pemrydi Rtu in US
20 Apr 2024 05:47 GMT
… Pemetrexed InjectionPemetrexed...
Karnataka: Shilpa Medicare';s marketing partner, Amneal Pharmaceuticals, has launched PEMRYDI RTU (Pemetrexed … Medicare gets Code J for Pemetrexed Injection
Pemetrexed Injection is used as a drug, in the treatment …
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Summary of opinion: Rybrevant, 25/04/2024 Positive
26 Apr 2024 12:53 GMT
… the marketing authorisation for the medicinal product Rybrevant. The marketing authorisation … holder for this medicinal product is Janssen-Cilag … with carboplatin and pemetrexed for the first‑line treatment of adult patients …
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EU OK sets up first ex-China launches for BeiGene's Tevimbra
24 Apr 2024 09:45 GMT
… Tevimbra as first-line treatment in combination with carboplatin … drug’s label also covers first-line use in combination with pemetrexed … and the FDA has recently insisted that trials supporting US … patients.
BeiGene’s chief medical officer, Mark Lanasa, …
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Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab
25 Apr 2024 02:11 GMT
… Journal of the American Medical Association (JAMA). The … or completed pivotal clinical trials evaluating the safety and … with pemetrexed and platinum as the first-line treatment in … responsibilities of a Chinese pharmaceutical company through its involvement …