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Genetron Health’s semiconductor-based NGS system gets Chinese approval

Genetron Health’s semiconductor-based NGS system gets Chinese approval

Genetron Health has been granted approval by China’s National Medical Products Administration (NMPA) for GENETRON S5, its semiconductor-based next-generation sequencing system (NGS system). With the approval, the Chinese precision oncology company can launch the new desktop medium-throughput NGS system for clinical applications. The NGS system has been developed by Genetron Health for the detection of […]

Lilly launches LIBRETTO-431 clinical trial for selpercatinib in NSCLC

Eli Lilly and Company (Lilly) has initiated the phase 3 LIBRETTO-431 clinical trial to evaluate selpercatinib (LOXO-292) in RET fusion-positive non-small cell lung cancer (NSCLC) in patients who are treatment-naïve. The US pharma company is aiming to enroll 400 patients in the late-stage clinical trial. The patients will be grouped randomly to be subjected to […]

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Biodesix acquires Oncimmune’s laboratory and IPN malignancy test in US

Biodesix, a lung cancer diagnostic solutions company, has acquired UK-based Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the US, to expand its blood-based lung cancer diagnostic portfolio. Oncimmune’s US commercial and lab operations, including a Clinical Laboratory Improvement Amendments (CLIA) lab in DeSoto, Kansas, has now been transferred to Biodesix. The Kansas […]

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OncoCyte to acquire Razor Genomics to advance lung cancer diagnosis

OncoCyte acquisition of Razor Genomics : US diagnostic tests developer OncoCyte has agreed to acquire Razor Genomics, a provider of molecular diagnostic testing services for lung cancer. Initially, the diagnostic tests developer will acquire an initial 25% equity interest in the form of the Razor Genomics’ preferred stock for $10 million. After closing of the […]

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Tagrisso FLAURA trial results : AstraZeneca NSCLC drug significantly improves OS

Tagrisso FLAURA trial results : Pharma giant AstraZeneca said that the phase 3 FLAURA trial evaluating Tagrisso (osimertinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) has yielded positive overall survival (OS) results. The randomized, double-blinded, multicenter late-stage trial featured NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) […]

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Ethicon wraps up $3.4bn acquisition of robotic medical company Auris Health

Ethicon acquisition of Auris Health : Johnson & Johnson’s subsidiary Ethicon has wrapped up its previously announced $3.4 billion acquisition of California-based robotic medical company Auris Health. Ethicon acquisition of Auris Health Based on the achievement of certain predetermined milestones, the deal will see additional contingent payments made by Ethicon worth up to $2.35 billion. […]

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Pfizer lung cancer drug Vizimpro bags CHMP’s positive opinion

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Pfizer lung cancer drug Vizimpro (dacomitinib) 45 mg in Europe as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The positive opinion adopted by the European Medicines Agency (EMA) committee is […]

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InventisBio out-licenses lung cancer drug D-0316 to Betta Pharma

InventisBio (Shanghai) has agreed to out-license the rights of its EGFR-T790M tyrosine kinase inhibitor D-0316 in China, Hong Kong and Taiwan to Betta Pharma, in a deal worth more than RMB230 million ($33.44 million). The two Chinese pharma companies have forged a partnership to co-develop the drug in China. D-0316, which was discovered by InventisBio, […]

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CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

Update on Imfinzi EMA approval : The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca lung cancer drug Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The committee has recommended Imfinzi EMA approval of […]

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AstraZeneca lung cancer drug Tagrisso gets FDA breakthrough therapy designation

Pharma news updates : Tagrisso (osimertinib), the AstraZeneca lung cancer drug has bagged the breakthrough therapy designation (BTD) from the US FDA for the treatment of non-small cell lung cancer (NSCLC) in a first line setting. The BTD designation for the AstraZeneca cancer drug is specifically for treating metastatic NSCLC patients who have tested positive […]

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