Search Results for Oncology

Showing 1 – 25  of 35

FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches By Zachary Brennan - Published 14 November 2017

Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: Pazdur, Marks, Woodcock, oncology center of excellence

Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say By Zachary Brennan - Published 07 November 2017

Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy.

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

Tags: DNA sequencing, Oncology Center of Excellence, biomarker, OS

Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments By Zachary Brennan - Published 05 July 2017

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive sizable sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

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

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

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

Tags: Keytruda, Merck, biomarkers, oncology approvals

FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation By Zachary Brennan - Published 13 April 2017

Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: hematology and oncology, radiation therapy, cancer drugs

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

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs By Michael Mezher - Published 11 January 2017

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: National Cancer Institute, NCI, NCI Formulary, Oncology

FDA Officials Call for Including Adolescents in Adult Oncology Trials By Michael Mezher - Published 20 December 2016

A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Pediatric oncology, Adolescent oncology

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

Pazdur to Head New Oncology Center at FDA By Michael Mezher - Published 29 June 2016

Vice President Joseph Biden on Wednesday named the US Food and Drug Administration's (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Oncology Center of Excellence, OCE, Richard Pazdur

European Regulatory Roundup: EMA Debates Use of Single-Arm Oncology Trials (26 May 2016) By Nick Paul Taylor - Published 26 May 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Drugs, Government affairs, Research and development

Tags: European Regulatory Roundup, EU roundup of news, single-arm oncology trials

European Regulatory Roundup: EMA to Allow Patient-Reported Outcomes in Oncology Trials (28 April 2016) By Nick Paul Taylor - Published 28 April 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Submission and registration

Tags: European Regulatory Roundup, MHRA, EMA, oncology trials

EMA Offers Updated Draft Guidance on Human Clinical Trials for Cancer Drugs By Zachary Brennan - Published 16 March 2016

The European Medicines Agency (EMA) on Tuesday published new draft guidance on the evaluation of anticancer medicines in humans that covers all stages of clinical development.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: oncology clinical guidance, EMA guidance on oncology trials, cancer clinical trials

FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs By Michael Mezher - Published 16 March 2016

The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.

Categories: News, CBER, Biologics and biotechnology, Clinical, Manufacturing, Research and development

Tags: CAR T-cells, chimeric antigen receptors, CD19, Recombinant DNA Advisory Committee, Cancer, Oncology, Juno, Kite, Novartis, B-cell lymphoma, Investigational new drug application, IND

Analysis: Breakthrough Therapies Cut Development Timeline by Two Years By Michael Mezher - Published 11 March 2016

A nonprofit cancer advocacy group says that the US Food and Drug Administration's (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years.

Categories: News, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Breakthrough therapy designation, Accelerated approval, Oncology

FDA Discusses How to Regulate NGS Tests for Cancer Diagnoses By Michael Mezher - Published 26 February 2016

The US Food and Drug Administration (FDA) is seeking input on how to regulate next-generation sequencing (NGS) tests that can scan a tumor's genes to guide cancer treatments.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Labeling, Regulatory strategy, Submission and registration

Tags: Next-generation sequencing, NGS, Oncology panels, Public workshop

Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement By Mark Shapiro, MA, MBA - Published 17 December 2015

Mark Shapiro, vice president of clinical development at contract research organization Clinipace, considers a recent JAMA study on cancer drug pricing in a guest post for Focus. A rebuttal to this post by one of the authors of the JAMA article, Dr. Vinay Prasad, can be found here.

Categories: News, US, FDA, Drugs, Ethics, Government affairs, Manufacturing, Quality

Tags: cancer drug pricing, Clinipace, JAMA, novelty cancer drugs, oncology

Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little By Vinay Prasad MD, MPH - Published 17 December 2015

This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University.

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

Tags: cancer drugs, oncology drug pricing, JAMA, cancer drug approvals

US Bests Canada in Approving New Drugs to Treat Cancer, Study Finds By Michael Mezher - Published 28 January 2015

A new study appearing in the medical journal Cancer this week examines the differences in approval times for cancer drugs at the US Food and Drug Administration (FDA) and Health Canada.

Categories: News, Canada, US, FDA, Health Canada, Prescription drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: Cancer, Oncology, Drug Approvals, FDA vs Health Canada

UK's NICE Finds Roche's Avastin Not Cost-Effective for Ovarian Cancer By Louise Zornoza, RegLink - Published 18 December 2012

Categories: Regulatory Update, EMA, NICE, Reimbursement

Tags: Ovarian Cancer, HTA, Roche, Payor, Oncology, CER, UK

Astellas' Prostate Cancer Drug Receives Priority FDA Approval By Alexander Gaffney - Published 04 September 2012

Categories: FDA

Tags: Priority Approval, Xtandi, Astellas, Prostate Cancer, Approved, Oncology, Latest News, cancer

FDA: Send Us Your Pediatric Oncology Drugs By Alexander Gaffney - Published 07 August 2012

Tags: ODAC, Pediatric, Oncology, Latest News, cancer

Study: Less Affluent Less Likely to Participate in Clinical Trials By Alexander Gaffney - Published 05 June 2012

Tags: Income, Oncology, cost, Latest News, clinical trials

FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages By Alexander Gaffney - Published 05 June 2012

Categories: FDA

Tags: Accelerated Approvals, Conditional Approvals, Pazdur, Oncology, Latest News, Drug Shortages, cancer

Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs' By Alexander Gaffney - Published 09 May 2012

Categories: FDA

Tags: Drug Approvals, GI, Approval Times, BCG, CHI, Priority Review, CNS, Report, time, Oncology, Latest News, pharmaceutical, drug, PDUFA