Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (...

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents. According to the complaint , Amgen has opted into the information exchange procedures under the Biologics Price Competition and Innovatio...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will allow Roche’s atezolizumab to be used as part of an early access program for locally advanced or metastatic urothelial carcinoma. In terms of why the new treatment won a positive Early Access to Medicine Scientific (EAMS) opinion, MHRA said: “Atezolizumab has been shown to slow the progression of cancer and increase patient survival in a condition where other treatments currently h...

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance. "Next generation sequencing has the capability to replace previous methods with a single approach to accomplish what might have required several different tests in the past," FDA explains. "In contrast to human sequencing di...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older. Tamiflu, first approved in 1999, earned Roche more than $3 billion back in 2009 and more than $400 million in 2015, though its effectiveness was questioned back in 2014. Now, India-based Natco and ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Revised Guideline on Development of Axial Spondyloarthritis Drugs The European Medicines Agency (EMA) has released a revised guideline on clinical development of treatments for axial spondyloarthritis for consultation. EMA is proposing the revisions to bring the text in line with the evolution in clinical practice since it published its original guideline in 200...

The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus. In a statement, the agency said it is allowing the test, developed by Roche Diagnostics, to be used to screen blood in areas, such as Puerto Rico , where the virus is actively transmitted. When reached for comment, Roche spokesman Bob Purcell told Focus that screening with the test will begin "in the next few ...

India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss. The notice comes just two days after officials in two Indian states put sales of the cancer drug on hold after injections of the drug damaged the vision of 15 patients in the western state of Gujarat. According to Reuters, ...

On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015. Background Health authorities around the world have been eyeing Avastin (bevacizumab) as a cheaper alternative to Novartis' Lucentis (ranibizumab injection). After being app...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage. Kadcyla (trastuzumab emtansine) treats women with m...

More than a year after initiating an investigation into "serious" pharmacovigilance shortcomings at Roche, EU regulators say they have found new evidence of unreported adverse events associated with the company's products, but that none will be withdrawn from the market. Background In October 2013, UK regulators conducting an inspection of Roche said they found "Serious shortcomings" with respect to the company's pharmacovigilance practices and processes that resulted i...