The UK's National Institute for Health and Care Excellence (NICE) opened a consultation on 6 August 2013 on its draft recommendation against reimbursement for Roche's breast cancer drug Perjeta (pertuzumab).  The negative recommendation is grounded on cost, regulators said, despite the fact that the drug in combination with rastuzumab and docetaxel delays the spread of the cancer by six months more than either of the other oncology drugs alone.  NICE noted t...

India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...

The US Food and Drug Administration (FDA) this morning announced the approval of Kadcyla (ado-trastuzumab emtansine), a new breast cancer therapy for patient with HER2-positive, metastatic breast cancer that did not respond to prior treatment. The 22 February 2013 announcement by FDA follows the product's six-month expedited review by FDA under its priority review program, which has been used to approve other breast cancer therapies such as trastuzumab, lapatinib and per...

The UK's cost containment agency, the National Institute for health and Clinical Excellence (NICE), has issued draft guidance saying that while Roche's blockbuster cancer drug Avastin (bevacizumab) delays the spread of ovarian cancer when used in combination with paclitaxel and carboplatin, it is not recommend as a cost-effective treatment. NICE's Appraisal Committee concluded that Avastin in combination with the other two cancer drugs showed a difference in median pr...

The British Medical Journal (BMJ) has launched a new regulatory-focused initiative it hopes will spur EU regulators to mandate the public release of data generated during the course of clinical investigations into healthcare products. In a series of articles released in its 29 October 2012 issue, the BMJ said it was joining with a host of other data transparency campaigners, including author Ben Goldacre and the editors of several prestigious medical journals in th...

The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...

In final guidance published 27 June, the UK's National Institute for Health and Clinical Excellence (NICE) does not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors as first line treatment options for metastatic breast cancer. The guidance notes it is unclear how much either drug can improve overall survival compared to existing treatments and as a result they do not represent value for money for the NHS. Th...

The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators. The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection ...

Draft guidance issued by the National Institute for Health and Clinical Excellence (NICE) on 15 June 2012 does not recommend the use of Roche's new melanoma drug, vemurafinib, by the National Health Service (NHS). "Vemurafenib is an expensive drug and its long term benefits are difficult to quantify," Sir Andrew Dillon, Chief Executive of NICE said. The data submitted by Roche, which compared vemurafenib to the current standard treatment using dacarbazine, showed...

A rash of counterfeit drugs invading the European pharmaceutical supply chain is spurring EU legislators to develop a new anti-counterfeiting directive that has attracted both the praise and scorn of regulated industry, reports Reuters . The European Commission's planned Directive involves requiring pharmaceutical products "to be sold in tamper-proof packs from 2016, each with a unique identifier allowing them to be tracked through the supply chain," writes Reuters . ...

The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April. The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear t...

The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data. Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding cert...