From Stat

Pfizer’s Chessmaster: How a Top Scientist Helped Invigorate a Lumbering Drug Giant

September 4, 2019

In his office at Pfizer’s 42nd Street headquarters in Manhattan, Chief Scientific Officer Mikael Dolsten keeps a chessboard. Dolsten has played since he was a boy in Sweden, but this board has a special provenance: It was a gift from former Pfizer (PFE) CEO Jeff Kindler, after Dolsten delivered to his boss the unwelcome message, in 2009, that the turnaround of the drug giant’s research laboratories would be anything but rapid.

In his office at Pfizer’s 42nd Street headquarters in Manhattan, Chief Scientific Officer Mikael Dolsten keeps a chessboard. Dolsten has played since he was a boy in Sweden, but this board has a special provenance: It was a gift from former Pfizer (PFE) CEO Jeff Kindler, after Dolsten delivered to his boss the unwelcome message, in 2009, that the turnaround of the drug giant’s research laboratories would be anything but rapid.

“I told him that, look, it’s not just one investment, it is like playing chess,’’ Dolsten recalled. “You need to have a picture of the entire opening game, win the middle game, and be really good in the end game. And it’s a marathon, Jeff, I told him.” Kindler left the meeting unhappy, but a few days later he appeared in Dolsten’s office with the chess set and his own words of wisdom: “Mikael, Pfizer needs a real chess player.”

Ten years later, Dolsten is serving under his third Pfizer CEO, one of the longest-serving research chiefs in pharma. And Pfizer is betting on his chess game as never before….

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Medicare Part D Paid Millions for Drugs Already Covered by Part A Hospice Benefits

August 28, 2019

Despite a previous warning, the Center for Medicare and Medicaid Services failed to take steps to ensure the Medicare Part D program does not also pay for medicines that should be covered under the Medicare Part A hospice benefit, resulting in an estimated $161 million in duplicate payments in 2016, according to a new federal government analysis.

Specifically, Medicare, Part D paid $422.7 million for 6.7 million prescriptions for beneficiaries who received hospice care. Hospice organizations should have provided and paid for the drugs, which were essentially paid for twice through payments to hospice organizations and again through Part D. And hospices or beneficiaries should have paid for the remaining $262 million in Part D total cost.

Despite a previous warning, the Center for Medicare and Medicaid Services failed to take steps to ensure the Medicare Part D program does not also pay for medicines that should be covered under the Medicare Part A hospice benefit, resulting in an estimated $161 million in duplicate payments in 2016, according to a new federal government analysis.

Specifically, Medicare, Part D paid $422.7 million for 6.7 million prescriptions for beneficiaries who received hospice care. Hospice organizations should have provided and paid for the drugs, which were essentially paid for twice through payments to hospice organizations and again through Part D. And hospices or beneficiaries should have paid for the remaining $262 million in Part D total cost….

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Can a New Lyme Disease Vaccine Overcome a History of Distrust and Failure?

August 22, 2019

As the threat of Lyme disease grows and fears surrounding it spread faster than the ticks that carry the infection, researchers are developing two vaccine or vaccine-like approaches to prevent this increasingly problematic disease. But don’t expect to get one soon. They are at least three to five years away from clinical use, according to their developers.

As the threat of Lyme disease grows and fears surrounding it spread faster than the ticks that carry the infection, researchers are developing two vaccine or vaccine-like approaches to prevent this increasingly problematic disease. But don’t expect to get one soon. They are at least three to five years away from clinical use, according to their developers.

That may seem like a long time to wait, especially since there are several Lyme disease vaccines available for dogs. But it’s taken researchers almost two decades to get this close — for the second time. Developers have faced an uphill battle since LYMErix, a short-lived human vaccine, was pulled from the market in 2002 amid low demand and lawsuits over potential side effects, not to mention mounting distrust in vaccines.

“There was a huge dampening of enthusiasm after LYMErix failed,” said Sam Telford, professor of vector-borne infections and public health at Tufts University, who helped run the LYMErix clinical trial. “Companies said, ‘Look, we just don’t want to go there.’ There was a lot of negativity around making a new Lyme disease vaccine….”

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The Pfizer-Mylan Deal Is Not Quite as It Appears

July 29, 2019

The early reaction to the pairing of generic drug maker Mylan Laboratories and Pfizer’s generics unit, Upjohn — officially announced Monday — is that it’s great for Mylan but maybe not so amazing for Pfizer. A close look at the deal may lead to a reassessment on both fronts.

For Pfizer, the deal represents the culmination of nearly a decade-long strategy to sell off or spin off non-core units one by one, including its veterinary business, a baby formula business, its consumer products division, and now its generics business.

The early reaction to the pairing of generic drug maker Mylan Laboratories and Pfizer’s generics unit, Upjohn — officially announced Monday — is that it’s great for Mylan but maybe not so amazing for Pfizer. A close look at the deal may lead to a reassessment on both fronts.

For Pfizer, the deal represents the culmination of nearly a decade-long strategy to sell off or spin off non-core units one by one, including its veterinary business, a baby formula business, its consumer products division, and now its generics business. For Mylan, there are big risks, including managing the prospects for aging Pfizer brands such as Lipitor and Viagra in China and other markets and doubling both the company’s annual sales and its debt.

And yet in morning trading, Pfizer shares edged down 1.7% to $42 and Mylan’s share price increased 10.6% to $20.43; the deal was first reported by the Wall Street Journal on Saturday….

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Senate Committee Unveils Ambitious Plan to Cap Drug Price Hikes, Out-of-Pocket Expenses

July 23, 2019

A key Senate committee on Tuesday unveiled a long-awaited package of drug pricing reforms that would cap how much drug makers can hike their prices in Medicare. It would also cap out-of-pocket expenses for Medicare beneficiaries and dramatically reform the program’s prescription drug benefit.

The bipartisan effort, spearheaded by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), is projected to save the federal government $85 billion on drug spending over the next decade.

A key Senate committee on Tuesday unveiled a long-awaited package of drug pricing reforms that would cap how much drug makers can hike their prices in Medicare. It would also cap out-of-pocket expenses for Medicare beneficiaries and dramatically reform the program’s prescription drug benefit.

The bipartisan effort, spearheaded by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), is projected to save the federal government $85 billion on drug spending over the next decade.

“This legislation shows that no industry is above accountability,” Wyden and Grassley wrote in a joint statement. “Passing these reforms, especially those that will affect some of the most entrenched interests in Washington, is never easy….”

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