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Sally Choe, outgoing director of the FDA's Office of Generic Drugs

FDA's top gener­ic drug leader puts in her two weeks as GDU­FA III looms

The FDA is about to lose another top leader with the departure of Sally Choe, director of the FDA’s Office of Generic Drugs, on Oct. 8. The departure coincides with the transition from the second reauthorization of the Generic Drug User Fee Amendments to the third reauthorization, which Congress has until Friday to finish up.

Choe, who didn’t immediately say where she’s heading post-FDA, but did a stint at Parexel, has served as the OGD director since February 2019, and “has been the principal medical and technical authority on all matters related to generic drug review and advised me and other agency officials,” CDER director Patrizia Cavazzoni said in an email to staff announcing Choe’s departure.

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Denise Scots-Knight, Mereo BioPharma CEO

Ru­bik's Cube still not solved at Mereo as ac­tivist in­vestor re­jects biotech's of­fer for board seats

Last month, Mereo BioPharma said its shareholders “deserve better” and in the latest setback at the UK biotech, the disgruntled 14% owner Rubric Capital Management has rejected an offer that the rare disease drugmaker thought would’ve solved the proxy fight.

The London biotech put out word Monday that it had offered up a principal and new director board seat to Rubric by having two existing Mereo directors retire. The offer didn’t entice Rubric amid a weekslong back-and-forth between the two parties, with Mereo sending multiple letters to the investor to defend itself and mitigate public concerns.

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Julie Brown, incoming GSK CFO (Roche)

With con­sumer health be­hind it, GSK taps As­traZeneca vet Julie Brown as CFO for R&D-fo­cused fu­ture

Four years ago, Emma Walmsley recruited Iain Mackay from the banking world to become GSK’s CFO, spotlighting his “track record of driving cost, cash and capital allocation discipline to deliver strategy.” Now that he’s helped oversee the spinoff of GSK’s consumer health unit, Walmsley is turning to an industry veteran for his successor.

Julie Brown, a veteran of AstraZeneca who recently switched lanes to become Burberry’s chief operating and financial officer, will join GSK as CFO in April as Mackay retires.

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Wendy Lund, WPP chief client officer for health and wellness

WPP taps Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund for new health and well­ness client role

Wendy Lund is going home – to WPP, that is. Lund is leaving the Merck women’s health spinoff Organon where she is chief communications officer for a newly created role as WPP chief client officer for health and wellness. Before Organon, Lund led GCI Group, a WPP healthcare communications agency, as CEO for 11 years.

Lund joins WPP’s group of global client leaders who act as a single point of contact or entry for clients with WPP brands and businesses inside the holding company. and in this case, for the WPP health and wellness business.

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Christopher Austin, Vesalius CEO

Months af­ter launch­ing with lofty goal, Flag­ship start­up stream­lines ops, chops head­count

Even by Flagship Pioneering’s standards, the stated goal at Vesalius Therapeutics — unveiled at its launch this March — was exceedingly ambitious. Armed with $75 million in Series A funding, the startup was out to “revolutionize the treatment of the diseases that drive ninety percent of human illness.” It would, as CEO Christopher Austin explained, deploy cutting-edge technology to look for underlying causes for a dizzying array of common diseases.

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Julian Adams, retiring Gamida Cell CEO

As Gami­da Cell eyes its first cell ther­a­py ap­proval, Ju­lian Adams is head­ing out

Julian Adams didn’t exactly finish what he set out to do at Gamida Cell, but it seems like he got close enough.

The seasoned biotech exec — who cemented his reputation at Millennium and then Infinity — is stepping down and passing the baton to Abigail Jenkins just after he steered the company toward its first BLA filing for a cell therapy. Gamida Cell is calling it a retirement, if that word still holds any weight in this industry.

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Kåre Schultz (Christopher Goodney/Bloomberg via Getty Images)

Still car­ry­ing the bud­get axe, Kåre Schultz is wrap­ping up his stint at Te­va, promis­ing to start pay­ing opi­oid set­tle­ment

Almost exactly five years ago, Teva captured the industry’s attention with its high-profile recruitment of Kåre Schultz at Lundbeck for the top job at the troubled generics giant. And now the CEO has his last year in view as he promises to finish the turnaround he had promised in 2017.

Schultz jumped to Teva for an initial pay package worth more than $44 million — including a whopping $20 million bonus right off the bat. Plagued by thinning margins and falling prices, he initially focused on making deep cuts to the organization in an effort to fix what ailed it while paying down a heavy debt load.

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Tom Hallam, Palisade Bio CEO

Pal­isade Bio is the lat­est to re­struc­ture, hun­ker­ing down on its lead pro­gram

Like so many other biotechs in the bear market, Palisade Bio is looking to play the reorg game and lay off parts of its staff.

The Carlsbad, CA-based biotech announced on Thursday that it will be putting a series of measures in place to “reduce operating expenses and preserve capital.” Palisade Bio CEO Tom Hallam said in a statement that due to current market conditions, and to ensure that it pushes forward in developing its lead candidate, 20% of the workforce will be let go.

Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Scoop: Ab­b­Vie, Bris­tol My­ers bring out the bud­get axe, out­lin­ing plans to lay off more than 350 West Coast em­ploy­ees

WARN notices in California have shed light on some of the inner workings of biotech and pharma — and newly unveiled notices point at two of the industry’s largest players.

AbbVie and Bristol Myers Squibb separately notified the state earlier this week that they plan on letting go 360 employees combined by the end of November — almost 100 at AbbVie and the rest from Bristol Myers.

AbbVie did not respond to repeated attempts for clarification from Endpoints News.

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Chris Giordano, Tenax Therapeutics CEO

Trou­bled times: With its back against the wall, lit­tle Tenax sends out an SOS while IMV takes out the bud­get axe, chops staff

The tally of restructurings in biotech continued to go up today with news from two small players that are in financial hot water.

Tenax Therapeutics may be down to its final crisis.

After years of spikes and plunges, the share price has long been flatlined in penny stock territory. And with dwindling cash and a “going concern” alert in its SEC filings, the executive crew is doing what it can to see about setting up a deal of some kind — and everything, including a sale, is on the table.