Search Results for BIO

Showing 1 – 25  of 31

BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding By Zachary Brennan - Published 14 June 2017

The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act. 

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: drug compounding, PhRMA, BIO, Pew Charitable Trusts, DQSA

Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs By Zachary Brennan - Published 04 April 2017

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: user fees, PDUFA, BsUFA, MDUFA, GDUFA, AdvaMed, BIO, AAM

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

ICH Offers Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump By Michael Mezher - Published 19 December 2016

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: PDUFA VI, User Fees, Trump, BIO

BIO Chair: Trump Should Re-Appoint Califf to Head FDA By Zachary Brennan - Published 17 November 2016

In a phone interview with Focus on Thursday, Ron Cohen, MD, president and CEO of Acorda Therapeutics and chair of industry group BIO, offered his views on increasing funding for the US National Institutes of Health (NIH), what the future may hold for the US Food and Drug Administration (FDA), as well as some new ideas and possible solutions to help contain rising drug prices.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Robert Califf, BIO, Acorda Therapeutics, CRISPR

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals By Zachary Brennan - Published 24 August 2016

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, BIO, PDUFA VI, Prescription Drug User Fee Act

EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot By Zachary Brennan - Published 17 June 2016

The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program.

Categories: News, Europe, EMA, Compliance, Drugs, Government affairs, Postmarket surveillance, Research and development

Tags: adaptive pathways, Oxford, Cambridge, fast-track, Bluebird Bio

PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition By Zachary Brennan - Published 21 January 2016

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Submission and registration

Tags: biosimilar labels, US biosimilar market, Omnitrope, PhRMA, BIO

Industry Calls for Clarity, Phased Approach for Quality Metrics By Michael Mezher - Published 04 December 2015

Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy

Tags: Quality Metrics, PhRMA, GPhA, BIO

Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance By Michael Mezher - Published 04 November 2015

Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Preclinical, Regulatory strategy

Tags: Orphan drugs, Natural history studies, PhRMA, BIO, NORD

Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity By Zachary Brennan - Published 05 October 2015

Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.

Categories: News, Asia, Canada, Oceania, US, Biologics and biotechnology, Distribution, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: TPP, Trans-Pacific Partnership, biologics exclusivity, BIO, PhRMA, MSF

With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations By Alexander Gaffney, RAC - Published 06 August 2014

The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and Drug Administration (FDA) in the hopes of improving the drug development process, it announced today.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Prescription drugs

Tags: BIO, PDUFA, PDUFA VI, FDA Interactions, FDA Survey

PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Electronic Submissions, BIO, PhRMA, Latest News, eCTD, guidance

BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan By Alexander Gaffney, RAC - Published 26 March 2014

Categories: US

Tags: Biotechnology Industry Association, Clinical Trials Transparency, BIO, Latest News, clinical trials

BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines By Alexander Gaffney, RAC - Published 15 January 2014

Categories: US, FDA

Tags: Drug Shortage Rule, Vaccine, BIO, Drug Shortage, Latest News, Drug Shortages

Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful By Alexander Gaffney, RF News Editor - Published 15 August 2013

Categories: US, FDA

Tags: BIO, Report, PhRMA, Transparency, industry, PDUFA