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BIO Submits Comments Re: CY 2016 Medicare Outpatient Prospective Payment System (OPPS) Proposed Rule

Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) is pleased to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule regarding payment policies under the calendar year (CY) 2016 hospital outpatient prospective payment system (OPPS), published in the Federal Register on July 8, 2015 (the “Proposed Rule”).  

Brief of the Biotechnology Industry Organization as Amicus Curiae supporting neither party in Rapid Litigation Management Ltd.v. Cellzdirect Inc. (Appeal from the US District Court for the Northern District of Illinois)

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Brief of the Biotechnology Industry Organization as Amicus Curiae supporting neither party in Rapid Litigation Management Ltd.v. Cellzdirect Inc. (Appeal from the US District Court for the Northern District of Illinois)

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BIO and PhRMA as amici curiae supporting appellants and in favor of en banc reconsideration in Ariosa Diagnostics Inc et al v. Sequenom Inc. et al (Appeals from the US District Court for the Northern District of California)

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BIO Submits Comments on Draft EMA Guideline on Gene Therapy

The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.”

BIO Announces Appointment of Brian Baenig to Lead Food & Agriculture Section

Today, the Biotechnology Industry Organization (BIO) announced that long-time agriculture policy expert Brian T. Baenig will be joining BIO as Executive Vice President, Food & Agriculture Section.

BIO Statement on USPTO IPR Decisions

BIO released the following statement on the decision by the U.S. Patent and Trademark Office rejecting challenges to two patents held by Acorda Therapeutics...

BIO Submits Comments Re: ESRD PPS Proposed Rule

The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program(the “Proposed Rule”).    

BIO Submits Comments Re: CMP & Ceiling Price Proposed Rule

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit the following comments to the Department of Health and Human Services (HHS) in response to the proposed rule issued by the Health Resources and Services Administration (HRSA) on June 17, 2015, entitled 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation [RIN-0906-AA89] (the “Proposed Rule”).  

BIO Submits Comments Re: Medicaid MCO Proposed Rule

The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules (the "Proposed Rule").