News About The Industry

Why concerns about a “break down” in drug pricing are misplaced

June 1, 2019 | BIOtechNOW

Just moments after it was announced the FDA had approved a new treatment for spinal muscular atrophy, Dr. Peter Bach was warning about a “break down” in the U.S. drug pricing system. It’s unfortunate Dr. Bach would respond to the discovery of a miracle cure for a fatal disease with such doom and gloom. In stark contrast to a patient community who welcomed the “great news” as “an amazing advancement,” Dr. Bach described the search for new treatments for rare diseases as a “problem” that needs to be addressed. But his dire concerns are misplaced for a host of reasons. There is plenty of room for innovative treatments in our health care system. Dr. Bach has been part of the chorus of those warning about “skyrocketing” drug costs for some time, but the facts usually tell a different story. According to the Centers for Medicare & Medicaid Services, spending on retail prescription drugs increased just 0.4% in 2017, which is slower than the growth in spending on hospitals (4.6%), physician services (4.2%) and health care more generally (3.9%).

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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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