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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").   

BIO Submits Comments Re: ASCO Value Framework

The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback on the American Society of Clinical Oncology’s (ASCO’s) Value Framework released on June 22, 2015.  

New Study: Biofuel Use Saved 589.3 Million Tons of Carbon Emissions Over the Past Decade

At its tenth anniversary, the Renewable Fuel Standard's requirement to substitute biofuels for fossil fuels has displaced nearly 1.9 billion barrels of foreign oil and reduced associated carbon emissions by 589.3 million metric tons.

Statement Regarding the USPTO Proposed IPR Rule Amendments

BIO issued a statement regarding the United States Patent and Trademark Office’s (PTO) proposed changes to the rules governing the Patent Trial and Appeal Board (PTAB) inter partes review (IPR) proceedings...

BIO Submits Comments on Patient Preference Information

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”

14th Annual BIO Investor Forum to Celebrate Fierce 15 Winners amid Rising Investor Interest in Biotechnology

BIO Investor Forum to be held October 20-21 in San Francisco, California  

BIO Submits Comments on Male-Mediated Developmental Risk

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

BIO Names Jeanne Haggerty as Senior Vice President for Federal Government Relations

BIO announced the appointment of Jeanne Haggerty as Senior Vice President of Federal Government Relations.

BIO Comments on Established Conditions Reportable CMC Changes

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).