News About The Industry

FDA commissioner Scott Gottlieb announces he will resign

March 5, 2019 | NPR News

The commissioner of the Food and Drug Administration, Scott Gottlieb, announced Tuesday that he is resigning the position, effective in one month. Gottlieb won approval from many as an effective advocate for public health. Within the Trump administration, he stood out for his efforts to more tightly regulate several industries; he's been particularly intent on curbing vaping and making generic drugs more accessible.

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GE surges after agreeing to $21.4 billion sale of biopharma unit

February 25, 2019 | Bloomberg

When Larry Culp took command of flailing General Electric Co. late last year, his mandate was simple: be more aggressive. Fewer than five months later, investors are applauding. The shares soared Monday as Culp took his boldest step yet to rescue the troubled behemoth, agreeing to sell GE’s bio-pharmaceutical business to his former employer, Danaher Corp., for $21.4 billion. Culp halted plans to spin off the broader health-care business as GE focuses on completing the Danaher deal by year end. ... The bio-pharma unit, which makes equipment for manufacturing biotechnology and drug therapies, represents about $3 billion of GE Healthcare’s annual sales. The deal, expected to close by the end of the year, is not subject to a financing condition or a shareholder vote, GE said in a statement. GE will receive cash proceeds of about $21 billion while also transferring certain pension liabilities to Danaher. GE received plenty of interest in the bio-pharma operations, Culp said, and the deal with Danaher came together over the past few months. GE isn’t planning other big sales, he said.

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Long-awaited M&A boom will hit biopharma in 2019 despite persistent worries, prognosticators predict

December 19, 2018 | FiercePharma

When Congress passed a business-friendly tax package last year, pharma prognosticators predicted 2018 would be the year that mergers and acquisitions in the sector would finally gain steam. They were wrong. Despite the industry’s newfound ability to repatriate cash at a 15.5% tax rate versus the 35% rate they had to pay before, biopharma companies did not make 2018 the year of M&A. But 2019 will most certainly be that year, analysts say. Sure, many of the worries that kept potential acquirers on the sidelines last year still exist, but biotech valuations have come way down—the Nasdaq Biotechnology Index has dropped nearly 7% in the year ended Dec. 16, in fact—and that could make all the difference.

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FDA and DoD formalize collaboration to advance medical products

November 2, 2018 | FDA News Release

Today, the U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.

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New law extends ADUFA, funding FDA review of medicines for pets and livestock

August 14, 2018 | Washington Examiner

President Trump has signed a bill into law that extends a program funding medicines for pets and livestock. The legislation, collectively known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, or ADUFA, charges fees for drug and device applications and uses that money to speed up their review. That way, products can head to market faster, and animal owners can have less expensive or more effective drugs to use on animals who fall ill.

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