Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Fast Advance in Hepatitis C Care Prompts EMA to Revise Clinical Trial Guideline EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvi...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Rules for Public Hearings on Safety Reviews Ahead of dry run in July The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted rules of procedure for public hearings on safety reviews. PRAC, which could hold its first public hearing by the end of the year, is working on the initiative to give its members a way to gather the views of patients on safety is...

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. The US Food and Drug Administration (FDA) late Monday issued an alert to health professionals of the stoppages, noting that they should be aware that the cancer medicine Zydelig (idelalisib) is not approve...

Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel. Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said. Swissmedic is working with other EU authoritie...

As part of Health Canada’s transparency push , the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016. Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker , and specific details on the...

As the drug pricing debate continues in the US, the ministers of health of 10 Latin American countries recently persuaded pharmaceutical companies to lower the prices of several HIV/AIDS and hepatitis C treatments. In the first of two planned rounds of negotiations, the health ministers of MERCOSUR (which includes Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela and associate countries Chile, Peru, Colombia and Ecuador) earlier this week agreed to purchase the HI...

After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license. Background In the past two years, drugmakers have launched several drugs to treat hepatitis C (HCV), a disease which left untreated can lead to cirrhosis or liver cancer. The new generation of HCV treatments, led by Gilead's Sovaldi and Harvoni, are highly eff...

Gilead Sciences has launched an initiative to provide its hepatitis C (HCV) treatment Sovaldi to patients in the Republic of Georgia free of charge. The move is part of an effort by Gilead to demonstrate that its products can drastically reduce HCV prevalence, which the company hopes will encourage more widespread use of Sovaldi and its successor, Harvoni. In its first year, the program will cover treatment for 5,000 patients, with Gilead looking to expand the program t...

A generic drug maker has launched its copy of Gilead Sciences' hepatitis C drug Sovaldi—which costs $84,000 in the US—which it will sell in Bangladesh for just $900 under the brand name Hopetavir, Bloomberg reports . Incepta Pharmaceuticals, a Bangladeshi company, is selling a 12-week course of a generic version of Gilead Sciences' Sovaldi for $900—almost 99% less than Gilead’s US price for the drugs—and has its eye on other markets where Sovaldi is not patent...

A prominent Indian court has ruled that India's patent office erred when it invalidated a patent application owned by the pharmaceutical company Gilead, giving the company another chance to save its patent on the hepatitis C drug Sovaldi while the patent office revisits the application. Monday, Regulatory Focus  reported the outcome and major themes of the court’s decision. In this article Focus will take a closer look at the facts of the case and the court’s judg...

Gilead Sciences announced it is extending licensing agreements with eight Indian generic manufacturers to include rights to make a yet-to-be approved drug in combination with Sovaldi (sofosbuvir). Background: A New Drug In a press release on Gilead’s website, the company says the new combination, if approved, would be the first treatment that effectively treats all six genotypes of hepatitis C (HCV). Previous treatments for HCV tended to be effective in select subpopu...

The Canadian pharmaceutical company Knight Therapeutics has reportedly sold its Neglected Tropical Disease Priority Review Voucher to Gilead Sciences, making it the first time a tropical voucher has ever been sold. Background FDA maintains two types of priority review voucher programs, which allow companies to have their products reviewed by FDA in just six months instead of 10. The first and oldest of the voucher types is intended to facilitate development of products ...