Search Results for

Filtering on: "topics research and development"

Showing 1 – 25  of 221

Alligators and Crocodiles: New Indications for Use? By Max Sherman - Published 23 February 2017

This article provides current research in drug development and describes crocodilians, their immune function, the search for new antibiotics, antimicrobial peptides (also known as host defense peptides) and future research for anti-cancer agents.

Categories: Features, Biologics and biotechnology, Research and development

FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue By Zachary Brennan - Published 21 February 2017

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: oncology, Pazdur, Oncology Center of Excellence, FDA cancer drug approvals

Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics By Zachary Brennan - Published 20 February 2017

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

Categories: News, US, Biologics and biotechnology, Government affairs, Research and development, Submission and registration

Tags: biosimilars, GPhA, AAM, Biosimilars Council, Amgen, Sandoz

GOP Sets June Deadline for Completing FDA User Fee Reauthorizations By Zachary Brennan - Published 06 February 2017

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Medical Devices, Research and development

Tags: FDA user fees, PDUFA, MDUFA, BsUFA, GDUFA, user fee reauthorization

Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue By Zachary Brennan - Published 02 February 2017

Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote.

Categories: News, US, FDA, Clinical, Research and development, Submission and registration

Tags: historical control group, placebo, genetic marker, clinical benefit

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

Politicizing the FDA: What the Trump Win Means for New Pharma Regulations By Zachary Brennan - Published 19 January 2017

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Trump, FDA, FDA commissioner pick, Rob Califf

Insulin: The First Truly Miracle Drug By Max Sherman - Published 08 December 2016

This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved.

Categories: Features, Canada, Biologics and biotechnology, Research and development

Tags: Diabetes, Insulin, Drug Discovery

FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’ By Zachary Brennan - Published 08 December 2016

Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible."

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: 21st Century Cures, real-world evidence, real-world data and pharmaceuticals

House to Pass Revamped 21st Century Cures Bill By Zachary Brennan - Published 30 November 2016

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: 21st Century Cures, #CuresNow, Cancer Moonshot, FDA legislation, lame duck session

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

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

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

Draft CFDA Guidance on Drug Data Management Practices By Yingying Liu, Siegfried Schmitt - Published 31 October 2016

The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance.

Categories: News, China, CFDA, Clinical, Manufacturing, Preclinical, Research and development

Tags: Data Management

FDA Approves First PFO Occluder From St. Jude By Zachary Brennan - Published 28 October 2016

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PFO Occluder, St. Jude Medical, FDA device approval

EMA Prioritizes Three New Treatments as Part of its PRIME Scheme By Zachary Brennan - Published 19 October 2016

The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Research and development

Tags: PRIME, priority medicines, oncology

ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices By Zachary Brennan - Published 03 October 2016

In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival.

Categories: News, US, Biologics and biotechnology, Due Diligence, Ethics, Regulatory strategy, Reimbursement, Research and development

Tags: NSCLC, lung cancer, ICER

510(k) Third Party Review Program: FDA Offers New Draft Guidance By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices.

Categories: Canada, Europe, US, CDRH, Health Canada, IMDRF, MHLW, TGA, Government affairs, Manufacturing, Medical Devices, Research and development

Tags: 510(k) submissions, medical devices, third-party audits of medical devices, IMDRF, MDSAP

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

Biosimilar Interchangeability: ‘Careful What You Wish For’ By Zachary Brennan - Published 08 September 2016

As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: interchangeability, biosimilars, biologics and biosimilars, Momenta Pharmaceuticals, Pfenex, Sandoz, GPhA

Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London By Zachary Brennan - Published 06 September 2016

If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.”

Categories: News, Japan, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA, Brexit, UK approval of drugs

FDA Begins Process of Overhauling Off-Label Communications Regulations By Zachary Brennan - Published 31 August 2016

The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pharmaceutical off-label communications, Amarin, drug company free speech

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

Categories: News, US, FDA, Clinical, Drugs, Preclinical, Research and development

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

Cancer Immunotherapies: EMA to Hold November Workshop By Zachary Brennan - Published 16 August 2016

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

Categories: News, Europe, US, EMA, FDA, Business and Leadership, Clinical, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: CAR T, CAR T-cell therapies, immuno-oncology, immunotherapy, EMA workshop on immunotherapies