Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...

The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead. In the DH, two ministers will be jointly responsible for life sciences, including: Lord Prior of Brampton, Parliamentary Under Secretary of State for Health and former adviser to the health authority of Abu Dhabi, who will lea...

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products. In October 2015, FDA put out a request for more information on the types of technologies and innovations companies are employing to conduct clinical rese...

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals. “The risk in the canagliflozin groups was 6 per 1000 patient years, compared with 3 per 1000 patient years with placebo,” the regulators and Janssen UK and Ireland’s medical director ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK) manufacturing facility in Tianjin, China was non-compliant with Good Manufacturing Practices (GMPs). Simon Steel, spokesman for GSK, confirmed to RAPS that MHRA has withdrawn the GMP certificates from the site, which is currently not in operations as it undergoes repairs from an August explosion in Tianjin. The site manufactures ...

Could "electroceuticals" be the newest healthcare product category worth watching? UK life sciences manufacturer GlaxoSmithKline thinks it is, and is putting up money to what it deems is quite literally "the million-dollar question":  What promises might this new field of medicine hold? What Are Electroceuticals? In relative terms, a million-dollar bet isn't much considering the almost $40 billion in revenue GSK made in 2012, but it is a step in the right directi...

Under fire from industry critics, UK drug manufacturing giant GlakoSmithKline has announced its intent to publish clinical trials data-a first for both the company and the pharmaceutical industry, which has historically guarded such data closely to limit potential risk. In a statement, the company said it intends to share, "Detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patient...

The final stage of testing for a lung disease drug is finished, and GlaxoSmithKline (GSK) said it will seek global market approval, according to a Reuters report. GSK said the drug, LAMA/LABA, showed positive results in patients with chronic obstructive pulmonary disease (COPD). The company plans to present the full results from four late-stage trials at future scientific meetings. Reuters reports GSK wants to develop a successor to Advair, a lung drug that was reported...

British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs. In a statement released 2 July , US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupr...

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...

A new combination vaccine that protects infants against meningococcal disease and Hib disease received approval from the US Food and Drug Administration (FDA) on 14 June, the agency said. Reuters reports the vaccine, GlaxoSmithKline Biologicals'Menhibrix, had twice been rejected by the agency in both 2010 and 2011 after regulators raised questions about the benefit:risk profile of the product. The questions seemed to be resolved-or at least mitigated-during the product...

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...