For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
“This current administration is like nothing that we've seen before,” said a managing partner of a global venture capital firm who spoke to BioWorld on the condition of anonymity. “President Trump’s first term was bad,” he said, “but nobody knows what’s coming.” “This is truly nationalism at its worst, because he won on the campaign [largely] to protect American jobs, claiming that Americans have been unfairly treated.” And it's not just China, he said, but India and other countries will also likely be affected.
Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.
The Comma Collective Inc. raised $2 million in a seed round to support the launch of its secure period tracker and disease detection app, Sara, and further development of its products.
The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.
In keeping with the trend in med tech to return to basics, Becton, Dickinson and Co. plans to split off its biosciences and diagnostic solutions unit to create two pure-play companies. The ‘New BD’ or RemainCo. will be a focused medical technology company that will include the current company’s medication delivery, specimen management, patient monitoring, pharmaceutical systems, urology, critical care, peripheral intervention and surgery businesses.
Globus Medical Inc. reported it is buying Nevro Corp. in an all-cash transaction. Under the terms of the agreement, which was unanimously approved by the boards of both companies, Globus will acquire all shares of Nevro for $5.85 per share. The transaction represents a total equity value of approximately $250 million.
The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
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