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CYTOKINETICS, INCORPORATED

(CYTK)
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REFILE-UPDATE 4-Biden will nominate industry-friendly Califf to lead U.S. FDA

11/12/2021 | 11:36am EST

(Fixes typo in subhed)

* President Joe Biden to nominate Robert Califf as FDA chief

* Key drug regulator without permanent leader since January

* Califf led the agency under President Barack Obama

* Nominee criticized for pharmaceutical industry ties

WASHINGTON, Nov 12 (Reuters) - President Joe Biden on Friday said he would nominate Robert Califf for a second stint as commissioner of the U.S. Food and Drug Administration, and urged the Senate to swiftly confirm him.

Califf, 70, a well-regarded cardiologist and researcher closely linked with the pharmaceutical industry, served as FDA commissioner from February 2016 until the end of then-President Barack Obama's second term in January 2017.

"Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation's fight to put an end to the coronavirus pandemic," Biden said in a statement issued by the White House.

Califf was confirmed for his first term by the Senate 89-4 with broad bipartisan support, though at the time he faced criticism from some Democrats, like Senators Bernie Sanders of Vermont and Joe Manchin of West Virginia, who said his ties to the drug industry made him unfit to regulate it impartially.

At the time, Califf had co-authored papers with industry executives and served as a consultant for drugmakers. He was since hired by Google parent Alphabet Inc in 2019, and currently serves as the head of Clinical Policy and Strategy across its Google Health and Verily Life Sciences enterprises.

He is also on the board of drugmaker Cytokinetics Inc and has received consulting fees from pharmaceutical companies Amgen Inc, Boehringer Ingelheim, Biogen Inc , Eli Lilly and Co, Roche AG's Genentech unit, and Merck & Co Inc.

"Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment," Biden said in the White House statement.

The leading U.S. pharmaceutical trade association welcomed his nomination.

"We hope the confirmation process will proceed quickly, and we look forward to continuing to work with the FDA as we fight the pandemic and other deadly diseases," said Pharmaceutical Research and Manufacturers of America President Steve Ubl.

SENATE CONFIRMATION

Democrats have a razor-thin majority in the Senate. Manchin said on Friday he would oppose Califf's nomination.

"Dr. Califf's nomination and his significant ties to the pharmaceutical industry take us backwards not forward," Manchin said in a statement on Friday.

White House Press Secretary Jen Psaki said the Biden administration was confident Califf would be confirmed, pointing to his experience and prior confirmation.

"We feel he's a qualified person who has the exact experience for this moment," Psaki said at a briefing, adding that Manchin had ultimately voted to confirm him in 2015.

The FDA has been without a permanent leader since Biden took office in January.

If confirmed by the Senate, Califf will take over from longtime FDA veteran Janet Woodcock, who has been serving as acting commissioner. The FDA oversees everything from medicine and medical devices to food, tobacco and cosmetics.

Woodcock has been in the role since Biden took office but legally could not serve past Monday unless a permanent nominee was named. Biden thanked her for her work over the past year.

The FDA has been in the spotlight as it reviews vaccines and potential treatments for COVID-19, and came under additional scrutiny for its accelerated approval this year of Biogen Inc's Alzheimer's drug, Aduhelm, against the recommendation of its outside expert advisers.

Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine, the White House said. He is a longtime faculty member at Duke University where he founded the Duke Clinical Research Institute, a large academic center that received over half its funding from the drug industry.

He joined the FDA in 2015 as deputy commissioner for Medical Products and Tobacco and worked closely with then-Vice President Biden on Cancer Moonshot, an initiative aimed at speeding development of cancer treatments. (Reporting by Andrea Shalal and Ahmed Aboulenein; Additional reporting by Katharine Jackson, Mrinalika Roy, Susan Cornwell, and Susan Heavey; Editing by Bill Berkrot, Raissa Kasolowsky, Aurora Ellis and Jonathan Oatis)


ę Reuters 2021
Stocks mentioned in the article
ChangeLast1st jan.
ALPHABET INC. -0.65% 2702.33 Delayed Quote.-6.72%
AMGEN INC. -1.08% 231.3 Delayed Quote.2.81%
BIOGEN INC. -1.28% 230.81 Delayed Quote.-3.80%
CYTOKINETICS, INCORPORATED -2.07% 31.71 Delayed Quote.-28.96%
ROCHE HOLDING AG 0.22% 365.7 Delayed Quote.-3.75%
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Financials (USD)
Sales 2021 20,4 M - -
Net income 2021 -249 M - -
Net cash 2021 289 M - -
P/E ratio 2021 -9,71x
Yield 2021 -
Capitalization 2 660 M 2 660 M -
EV / Sales 2021 116x
EV / Sales 2022 35,6x
Nbr of Employees 184
Free-Float 95,4%
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Managers and Directors
Robert I. Blum CFO, SVP-Corporate Development & Finance
Ching W. Jaw Chief Financial Officer & Senior Vice President
Leonard Patrick Gage Chairman
Andrew A. Wolff Senior VP-Clinical Research & Development
Fady Ibraham Malik Executive Vice President-Research & Development
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