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Category: Pharma Industry

Origin Biosciences Posts Limited Distribution Notice on 340B Program Site

In Federal, Pharma Industry, Regulatory24 Views Tom Mirga
The maker of Nulibry, a new, first-of-its-kind drug whose supply is limited, notified providers about how they can buy it at its 340B price.
The manufacturer of Nulibry, a recently approved, first-of-its-kind injectable treatment for a very rare, often fatal genetic disorder that typically appears soon after birth, has posted details about the limited distribution network for the drug on the U.S. Health Resources …
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Merck Pitches Its Voluntary 340B Integrity Initiative to Providers as a Better Option than Audits

In Pharma Industry21 Views Tom Mirga
Merck said in letters to 340B covered entities this week that its approach to solving problems with 340B contract pharmacy transactions "is more streamlined—and less burdensome on covered entities, HRSA, and Merck—than undertaking individual manufacturer audits" of entities and their pharmacy partners.
Drug manufacturer Merck sent letters to 340B covered entities by email on Tuesday to provide background and answer questions about its request that entities voluntarily upload their contract pharmacy claims to a vendor’s software platform so they can be checked …
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PhRMA: Providers Use 340B as “Slush Fund”

In Pharma Industry10 Views Tom Mirga
“We must stop abuses of the 340B program by covered entities who put profits before patients,” PhRMA spokesperson Nicole Longo says in the association's blog. | Shutterstock
The 340B program “attracts hospitals, clinics and for-profit pharmacies because it is easy for them to use the program as a slush fund to benefit their bottom lines, diverting money that could be used to help patients get better care …
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News Flash: State Attorney General Orders Sanofi to Hand Over 340B Information

In Pharma Industry, State39 Views Tom Mirga
So far, none of the other drug companies denying or imposing conditions on 340B pricing on contract pharmacy drugs have publicly reported being subpoenaed by Vermont Attorney General T.J. Donovan.
Vermont State Attorney General T.J. Donovan (D) has issued a subpoena to drug manufacturer Sanofi “seeking certain information about Sanofi’s 340B program participation,” the company disclosed last week.

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Orphan Drug Study’s Authors Say Findings May Warrant Lifting 340B Exemption

In Federal, Legislative, Pharma Industry, Research/Reports15 Views Tom Mirga
Humira, one of the 15 partial orphan drugs examined in the new study in Health Affairs, had $13.7 billion in sales in 2018.
More than 70 percent of U.S. spending on top-selling “partial orphan drugs”—drugs for rare diseases that also are approved to treat common diseases—is for non-orphan indications, a study in latest edition of Health Affairs concludes. Policymakers who “wish to decrease …
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AstraZeneca Tells Court HHS’s 340B Enforcement Poses “Imminent Irreparable Harm”

In Federal, Judicial, Pharma Industry18 Views Tom Mirga
AstraZeneca told a federal judge that federal enforcement of 340B contract pharmacy requirements threatens it with "imminent, irreparable harm.” | Shutterstock
Drug manufacturer AstraZeneca on Friday asked the federal district judge in Delaware handling its 340B contract pharmacy lawsuit against the federal government either to issue a preliminary injunction in its favor or expedite court proceedings “to prevent imminent irreparable harm” …
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PhRMA Slams 340B Hospitals in Report, AHA Returns Fire

In Pharma Industry, Research/Reports13 Views Tom Mirga
The AHA contests PhRMA's conclusion in its new report that 340B program growth drives up drug costs for patients and employers.
The ability to generate profits through the 340B program prompts hospitals to buy physician practices and shift delivery of care to more costly hospital outpatient settings, driving up drug costs for patients and employers, Pharmaceutical Research and Manufacturers of America …
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Drug Manufacturers GSK and Esperion Offering Refunds for 340B Overcharges

In Federal, Pharma Industry, Regulatory9 Views Tom Mirga
Glaxo Smith Kline has notified 340B covered entities about the availability of refunds for overcharges early in 2019. | Shutterstock
Drug manufacturer Glaxo Smith Kline (GSK) yesterday notified 340B covered entities on the U.S. Health Resources and Services Administration (HRSA) website that it is offering refunds for overcharges on about two dozen NDCs during the first quarter of 2019. …
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