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STAT+: The next step of site-neutral, and a fiery PBM hearing

This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.

Hello, everyone! I’ve seen upwards of 50,000 public comments on proposed health care regulations, but the 200,000 comments (!) on the SEC’s proposal to eliminate quarterly financial reports is jaw-dropping. Yes, a lot of them seem like automated templates from interest groups, but still. Some poor soul has to sift through them. I’d like to see you try to send 200,000 comments here (please don’t): bob.herman@statnews.com.

Site-Neutral Milk Hotel

The most consequential policy in Medicare’s recent outpatient rule is the cuts to drugs that hospitals get under the 340B discount program. But the Centers for Medicare and Medicaid Services subtly doubled down on another major policy that hospitals loathe.

Continue to STAT+ to read the full story…

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This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.

Hello, everyone! I’ve seen upwards of 50,000 public comments on proposed health care regulations, but the 200,000 comments (!) on the SEC’s proposal to eliminate quarterly financial reports is jaw-dropping. Yes, a lot of them seem like automated templates from interest groups, but still. Some poor soul has to sift through them. I’d like to see you try to send 200,000 comments here (please don’t): bob.herman@statnews.com.

Site-Neutral Milk Hotel

The most consequential policy in Medicare’s recent outpatient rule is the cuts to drugs that hospitals get under the 340B discount program. But the Centers for Medicare and Medicaid Services subtly doubled down on another major policy that hospitals loathe.

Continue to STAT+ to read the full story…

Read More

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Heart transplants fail if patients get too weak. New program tries inpatient prehab 

Cardiologists see this happen all too often: A patient is waiting in the hospital for a heart transplant, only to be disqualified because their fitness has fallen with each day in bed. 

Dismayed by such cases, Radha Gopalan, a heart transplant cardiologist at Banner–University Medical Center Phoenix, decided to try a twist on other rehabilitation programs.

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Cardiologists see this happen all too often: A patient is waiting in the hospital for a heart transplant, only to be disqualified because their fitness has fallen with each day in bed. 

Dismayed by such cases, Radha Gopalan, a heart transplant cardiologist at Banner–University Medical Center Phoenix, decided to try a twist on other rehabilitation programs.

Read the rest…

Read More

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Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

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As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.​ ​Read More

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Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out

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The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

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