Search Results for cancer drugs

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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

European Regulatory Roundup: Proposal for a European Drug Pricing Initiative (6 October 2016) By Nick Paul Taylor - Published 06 October 2016

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

Categories: News, Europe, Biologics and biotechnology, Drugs, Government affairs

Tags: EU Regulatory Roundup, drug pricing, cancer drugs fund

Researchers Propose Framework to Validate Surrogate Endpoints By Michael Mezher - Published 08 June 2016

A team of researchers and health officials, including European Medicines Agency (EMA) Executive Director Guido Rasi, are proposing a three-step validation process to enhance the use of surrogate endpoints in regulatory and reimbursement decision-making.

Categories: News, Europe, EMA, NICE, Clinical, Drugs, Regulatory strategy, Reimbursement

Tags: surrogate endpoints, reimbursement decisions, HTA, cancer drugs

US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries By Zachary Brennan - Published 12 May 2016

New Jersey-based generic drugmaker Heritage Pharmaceuticals last week announced that counterfeit drugs labeled the same as its 100mg chemotherapy BiCNU (carmustine for injection) have been sold and distributed in India, Ireland and Israel.

Categories: News, Asia, Europe, Middle East, US, FDA, Biologics and biotechnology, Crisis management, Government affairs

Tags: generic cancer drugs, Heritage Pharmaceuticals

Genomic Data and Drug Development: EMA Offers New Draft Guidance By Zachary Brennan - Published 02 May 2016

As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Crisis management, Government affairs, Quality

Tags: pharmacogenomics, liquid biopsy, cancer drugs and genomics, EMA guidance

Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events By Zachary Brennan - Published 15 March 2016

Biotech juggernaut Gilead Sciences is halting six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas after an increased rate of serious adverse events, including deaths, mostly due to infections.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Drugs

Tags: Gilead, cancer drugs, Zydelig, idelalisib

European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016) By Nick Paul Taylor - Published 03 March 2016

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

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: good pharmacovigilance practices, NICE, Cancer Drugs Fund, Swissmedic

Orphan Medicines in the EU: A 15-Year Review By Zachary Brennan - Published 29 January 2016

With the 15th anniversary of the adoption of the Orphan Regulation in the EU, the European Commission notes in a new report that this landmark regulation has incentivized the development, approval and marketing of more than 100 rare disease treatments, or orphan drugs.  

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Orphan products, Research and development

Tags: orphan medicines, rare disease drugs, cancer drugs, orphan drug incentives

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

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

UK Agencies Look to Overhaul Cancer Drugs Fund By Zachary Brennan - Published 19 November 2015

The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Blood, Crisis management, Drugs, Government affairs, Preclinical, Quality, Reimbursement, Research and development

Tags: cancer drugs, biotech, NICE, NHS, UK cancer drugs, EMA