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D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case

FDA Law Blog

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

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New York City’s Building Electrification Law Wins in District Court

ClimateChange-ClimateLaw

Last week, building electrification secured an important victory in the United States District Court for the Southern District of New York. In Association of Contracting Plumbers of The City of New York, Inc. Judge Abrams Decision in Association of Contracting Plumbers of The City of New York, Inc.

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Second Circuit Decision A Reminder that Alleged FDCA violations don’t always equal FCA violations

FDA Law Blog

Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C In addition, Grifols’s eligibility for government contracts is conditioned on FDA approval of Gamunex and FDA approval is conditioned on compliance with GMPs.

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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Prefiling Offer by Business Partner Dooms Patent

Patently O

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. The Federal Circuit relies upon traditional contract law principles to determine whether a particular communication constitutes such an offer. Remember the contract foundational trio: Offer, Acceptance, Consideration.

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Motion to compel the arbitrations proceeding under federal equitable estoppel law denied: United States Court of Appeals for the Ninth Circuit

LexForti

According to the facts, the brothers Balkrishna and Nagaraj Setty signed an agreement for partnership where they became the joint owner of the incense manufacturing company. Later, the brothers started their own competing manufacturing companies in separate Indian Cities i.e., Bangalore and Mumbai.

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Western Apache group calls on court to block approval of copper mine on sacred site

SCOTUSBlog

A federal district court in Arizona rejected the group’s request to stop the land exchange, and the full U.S. Court of Appeals for the 9th Circuit affirmed that ruling. Pharmaceutical Research and Manufacturers of America v. McClain 24-118 Issue : Whether the U.S.

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