Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...

The White House’s $1 billion proposal to fund Vice President Joe Biden's “Moonshot” cancer initiative also includes several proposed investments in federal agencies, including $75 million for a new center at the US Food and Drug Administration (FDA). President Barack Obama’s State of the Union address singled out Biden as the leader of the expansive initiative that so far has few details, and which has raised some serious doubts from cancer researcher Vinay Prasad (who...

The World Health Organization (WHO) released a new report this week on ways to address global drug shortages, which are increasing in frequency, particularly for old, off-patent or difficult to formulate treatments. Difficulties in acquiring raw materials, manufacturing problems, barriers to competition, business decisions, the impact of new technologies, expensive medicines and fragmented markets were all listed as reasons for new drug shortages based on studies in seve...

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. According to the European Commission’s fourth inventory of orphan medicines, released Friday, somewhere between 5,000 and 8,000 different rare diseases exist in the EU, impacting between 27 million and 36 ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer. In the previous product informa...

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. Mr. Shapiro comments on some of the arguments made in our investigation o...

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 the post by one of the authors of the JAMA study, Dr. Vinay Prasad, can be found here . The last five years have been exceptionally busy in terms of oncology drug development. Two interesting articles that reflect back on this period of time were recently published. The firs...

Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...

As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...

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. As many in the UK, like the US, are distraught over the rise of cancer drug prices, NICE and NHS are proposing to turn the CDF, beginning in April ...

The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs. The warning comes more than a year after FDA inspectors visited Johnson Memorial's Enfield, Connecticut site from 16 July 2014 and 5 August 2014. During their inspection, FDA found "serious deficiencies" in the center's practices for producing compounded sterile drugs. The letter lists six ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates Data Quality Control, IT Papers as Introduction of New Process Nears The European Medicines Agency (EMA) has updated documents on data quality control and electronic filings ahead of the introduction of a new process in November. EMA will start using the new process on 4 November, at which time the regulator will start sending out alerts every time it vali...