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Filtering on: "topics research and development"

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FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: bioequivalence guidance, FDA draft guidance

FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

Researchers Discuss Regulatory Considerations for Tissue-Agnostic Cancer Drugs By Michael Mezher - Published 01 June 2017

In a paper set to be presented at the American Society of Clinical Oncology's annual meeting next week, three oncologists discuss some of the regulatory and scientific considerations for developing "tissue-agnostic" cancer treatments.

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

EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs By Michael Mezher - Published 01 June 2017

The European Medicines Agency (EMA) on Thursday launched a public consultation to gather input on a future reflection paper discussing the regulatory requirements for developing drugs to treat chronic non-infectious liver diseases.

Categories: News, Europe, EMA, Clinical, Drugs, Research and development, Submission and registration

Tags: NASH, PCS, PBC, Liver Disease, Drug Development

Medicine's Unsung Heroes By Max Sherman - Published 31 May 2017

This article introduces readers to Boyd Woodruff, a legend in the field of microbiology, and discusses his groundbreaking achievements in antibiotic development and Merck's research laboratories.

Categories: Features, US, Drugs, Research and development

EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine By Zachary Brennan - Published 19 May 2017

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.

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

Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds By Zachary Brennan - Published 08 May 2017

For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period.

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

Tags: surrogate markers, clinical endpoints, postapproval studies

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

Asia Regulatory Roundup: Australia Considers Some DTC Drug Ads (4 April 2017) By Nick Paul Taylor - Published 04 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices, Research and development

Tags: drug advertising, oxytocin, DRAP

Democrats Propose Wide-Ranging Bill to Lower Drug Costs By Zachary Brennan - Published 30 March 2017

House and Senate Democrats late Wednesday offered up a host of new provisions to bring down the rising cost of pharmaceuticals, many of which have been publicly opposed by the pharmaceutical industry.

Categories: News, US, FDA, Government affairs, Manufacturing, Research and development

Tags: drug prices, Medicare drug negotiations, drug imports, drug exclusivity, FDA regulations

Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations By Zachary Brennan - Published 27 March 2017

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Research and development

Tags: diagnostics, IVDs, IVCT, in vitro clinical test, LDT, lab-developed test

EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO By Zachary Brennan - Published 24 March 2017

The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.

Categories: News, Europe, EC, EMA, Compliance, Generic drugs, Product withdrawl and retirement, Research and development

Tags: Indian CRO, CRO suspension, EMA suspension, generic drugs

Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes By Zachary Brennan - Published 08 March 2017

A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations.

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

Tags: pediatric cancer clinical trials, BPCA, PREA, pediatric clinical trials

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