Keats Healthcare Ltd.

The ongoing development of a revolutionary shift in the structure of clinical trials known as Learn-Confirm, was warmly received by regulators, industrialists and academics gathered in Vienna for the 19th annual Drug Information Association conference this week.

Roche and Genentech's blockbuster agent Avastin has received approval for another indication in Europe, as a first-line treatment of women with metastatic breast cancer.

Patients in Liverpool are to trial a new therapy for pancreatic cancer - a disease which sees most sufferers die within a year of diagnosis.

One of the 10 most common cancers in the UK, it is among the most difficult to diagnose and treat and kills around 7,000 people each year. There are very few early symptoms so most patients present late and only around 15% are suitable for surgery.

A University of Missouri-Columbia study has found that newspapers' front page and section stories about clinical trials are overwhelmingly negative and that exposure to these stories may decrease people's willingness to participate in medical trials.

In the March 2006 Budget, Gordon Brown announced plans to allocate £1 billion for funding UK health research through a new Single Fund, which would replace the streams running through the Medical Research Council (MRC) and NHS Research & Development (R&D).

The Government commissioned an independent review, chaired by Sir David Cooksey (founder of Advent Venture Partners), to examine the arrangements and implementation of the new single fund. Cooksey published his report in December and the Chancellor accepted the findings.

Combining GlaxoSmithKline's respiratory drug Advair with Pfizer and Boehringer Ingelheim's Spiriva does not significantly reduce exacerbations in patients with chronic obstructive pulmonary disease, a new study claims.

In the trial carried out by Canadian researchers, the results of which have been published in the Annals of Internal Medicine, 449 patients with moderate to severe COPD were tested to see which of three inhaler regimens best prevented exacerbations.

In anticipation of a new wave of adaptive clinical trials, UK firm Tessella has designed a software system to help pharma firms conduct seamless trials that could ultimately save time and money.

The US Food and Drug Administration (FDA) recently announced it will begin providing guidance for the pharmaceutical industry on the use of adaptive research - which could cut the duration and ultimately the cost of clinical trials by one third - normally it takes at least six-to-nine months between phases while approval and drug manufacturing processes are completed.

A potential new law mandating the running of clinical trials before a "generic" biologic drug approval may seem like a potential goldmine for contract research organisations (CROs), however, this vision is premature.

If a new law is passed, the Food and Drug Administration (FDA) may soon have the authority to approve generic versions of biologic drugs in the US.

A small clinical trial of a medication to treat kleptomania has failed to find any conclusive benefit for patients with the impulsive stealing disorder, according to researchers at the Stanford University School of Medicine.

But the results leave open the possibility that some medications, including the one in the trial, may still be an effective treatment for certain patients.

Researchers at the Stanford University School of Medicine say they are puzzled by findings from their new study indicating that an antidepressant, which previously showed promise in treating a behavioral disorder known as compulsive buying, did not result in a sustained benefit for the patients who took it.

Liponex Inc. (TSX:LPX), a biopharmaceutical company specializing in developing advanced products related to High Density Lipoprotein (HDL), often called "good cholesterol," today announced results of the Phase I/II Clinical Trial of its lead product, CRD5. CRD5 is being developed for the treatment of dyslipidemia and heart disease. Results showed, to date, that CRD5 was safe and that the drug formulation was stable throughout the trial. However, the mean increase in HDL levels from the baseline, in both the 1 and 3 gram dosages was less than 5% and not statistically significant. The patient to patient variation was high and while some patients showed a strong increase in HDL, other patients had negative response. The Company will continue to assess the data from this trial over the next several weeks.

Novo Nordisk today announced that the European Commission has approved Levemir® (insulin detemir) for once-daily use in combination with oral antidiabetic drugs (OADs).

Levemir® initiated once daily significantly improves blood glucose levels, with less weight gain compared to NPH insulin and insulin glargine.(1-3) Levemir® is the first long-acting insulin associated with less weight gain and the weight benefit of Levemir® has been shown to increase with increasing baseline body mass index (BMI).(4) This makes Levemir® an appealing long-acting insulin for initiating early insulin treatment for people with type 2 diabetes.

The joint drug regulatory bodies of Australia and New Zealand are proposing a new scheme for assessing the risk of clinical trials.

The Australia New Zealand Therapeutic Products Authority (ANZTPA) said it wants to balance the need to protect the public health with the intention to foster clinical research and provide timely access to therapeutic products and is therefore proposing two separate routes for the clinical trial approval process under a new scheme based on the same risk-managed principles it currently uses to monitor approved medicines.

Cancer drug developer Antisoma plc (LSE: ASM, US OTC: ATSMY) today announces positive initial findings from its second, confirmatory phase II trial of AS1404 in non-small cell lung cancer.

This 30-patient trial tested an 1800 mg/m2 dose of AS1404 in combination with carboplatin and paclitaxel chemotherapy. Investigators reported a response rate of 50%. A further 43% of patients showed disease stabilisation, while only 7% had progressive disease as their best response. Addition of AS1404 to chemotherapy was well-tolerated despite the use of a dose 50% higher than that used in previous combination studies.

An anti cancer therapy that emits the most lethal from of radiation has successfully made it through second stage human trials.

Norway-based pharma, Algeta has developed a drug using a high-energy, relatively short-lived isotope of radium (223), which emits alpha-particle radiation. Alpharadin is being investigated as a means of killing prostate cancer cells that have spread to nearby bones and has recently successfully completed a Phase II trial. The results show that the therapy could extend survival by around six months.

For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential. A new analysis by researchers at the Harvard School of Public Health (HSPH) and Brigham and Women's Hospital (BWH) of laws and regulations governing public disclosure of clinical trial data submitted to the Food and Drug Administration (FDA) suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the March/April 2007 issue of Health Affairs.

Emisphere Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) announced today that Novartis Pharma AG and its development partner Nordic Bioscience have notified Emisphere of the initiation of a Phase III clinical trial for the treatment of osteoporosis with an oral form of salmon calcitonin (referred to as SMC021), a new drug candidate, using Emisphere's eligen(R) delivery technology. As a result of the initiation of the trial, Emisphere will receive a milestone payment from Novartis. The use of Emisphere's novel eligen(R) technology reflects the potential that for the first time salmon calcitonin may also be available as a convenient oral medication, rather than the currently available injectable or intranasal options.

SOUTH SAN FRANCISCO, Calif., March 01, 2007 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. , announced today that the company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for SNS-314, an internally-developed anticancer product candidate. SNS-314 is a targeted small molecule that selectively inhibits the Aurora kinases. Aurora kinases are key enzymes involved in cancer cell growth and division, and have a central role in the abnormal growth and proliferation of tumor cells.

India's budget finance minister has today announced a tax exemption on all services carried out by its contract research and clinical trials industry – a saving of 12.24 per cent.

The exemption proposal has been already approved by parliament and will come into effect at the start of India's financial year on 1 April 2007.