China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide.
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide. For all but one of the 13, the U.S. price is the highest.
The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.
The number of biopharma deals and mergers and acquisitions completed are on a downward slide quarter-by-quarter, although when taken as a whole, the industry in 2019 has completed as many transactions and is hitting a higher deal value than the year before, while M&A values are up by 32%.
In the third quarter, global biopharmaceutical companies collectively raised more than $12 billion from public and private transactions. Year to date (YTD), the sector has generated $41.5 billion, according to BioWorld data, putting it on track for a $55 billion haul for the year.
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