CSL Behring Confirms that First Gene Therapy for Hemophilia B Will Be Available at a 340B Price

CSL Behring
The FDA has approved CSL Behring's first-ever gene therapy to treat adults with hemophilia B.

The U.S. Food and Drug Administration (FDA) last week approved the first gene therapy to treat adults with hemophilia B, a genetic bleeding disorder resulting from missing or insufficient levels of a protein needed to make blood clot.

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HRSA Sanctions Manufacturer for Not Issuing Refund for 340B Overcharges

KVK Tech
HRSA has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

The U.S. Health Resources and Services Administration has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

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Fake Lilly Twitter Account Tweets “Insulin Is Free Now,” Temporarily Wiping Billions From Company’s Stock Value

Counterfeit insulin tweet
On Friday, a counterfeit Eli Lilly account bearing a checkmark that caused many to believe the account was authentic tweeted, “We are excited to announce insulin is free now," causing havoc.

The havoc caused by Twitter’s new policy on user identity verification struck drug manufacturer Eli Lilly last week when a counterfeit account bearing one of Twitter’s new $8 checkmarks tweeted, “We are excited to announce insulin is free

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GSK and Purdue Pharma Announce New Rounds of Refunds for 340B Overcharges

340B refunds for overcharges
GlaxoSmithKline and Purdue Pharma announced refunds for overcharging 340B covered entities, GSK for the fourth time and Purdue for the second time this year.

Drug manufacturers GlaxoSmithKline and Purdue Pharma have announced refunds for overcharging 340B covered entities, GSK for the fourth time and Purdue for the second time this year.

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HHS Official Under Trump Calls for “Honest Conversation” About 340B at it Reaches Age 30

John O'Brien
John O'Brien, architect of ex-President Trump's drug pricing blueprint, calls for more 340B transparency in a commentary for STAT.

Getting 340B pharmacy data to study trends and public health impacts “is like trying to catch a will-o’-the-wisp,” a former senior Trump administration health care official said in a commentary last week in the life sciences news publication

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Second of Three U.S. Appeals Court Hearings on 340B Contract Pharmacy Is Set for Monday

US Appeals Court Seventh Circuit
Oral arguments are scheduled for this Monday at the federal appeals court in Chicago over Lilly's 340B contract pharmacy restrictions.

Now that a federal appeals court in Washington, D.C., has heard arguments in Novartis and United Therapeutics’ 340B contract pharmacy lawsuits, the scene shifts to Chicago, where an appeals court will hear arguments Monday morning in Eli Lilly’s companion case.

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AIDS Advocates Holding Weeklong Protest Over Gilead’s 340B Contract Pharmacy Restrictions and Changes In Patient Assistance Program

AIDS advocates are holding a week long series of protests outside Gilead's California headquarters.

AIDS Healthcare Foundation (AHF) members are staging a weeklong, twice-daily series of protests at drug maker Gilead Science’s Northern California headquarters to protest the company’s policy to impose conditions on 340B providers that use contract pharmacies to dispense 340B-priced drugs.

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HRSA Cites Almaject for 340B Price Data Lapse, No Sanctions Imposed 

New Jersey-based generic manufacturer Almaject was cited for an infraction by HRSA during a recent audit. However, the company will not be sanctioned.

The U.S. Health Resources and Services Administration (HRSA) has cited Almaject, a New Jersey-based maker of generic injectables, with failing to submit quarterly pricing data into the 340B Office of Pharmacy Affairs Information System, although the agency did not impose

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Breaking News

HRSA Refers Merck to HHS Inspector General Over its 340B Contract Pharmacy Policy

Merck
Merck did not immediately comment on the governnment's referral yesterday to the HHS Inspector General for possible imposition of civil fines over the company's 340B contract pharmacy restrictions.

The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.

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