Bioethics has emerged as a new discipline over the past couple of decades and is poised to become a multidisciplinary specialty. Institutional review boards/Institutional ethics committees have evolved as conscience keepers of professionals with the view to safeguard the welfare of members of society against any possible harm from scientific advances. Bioethical discussions and debates provide perspectives on the relevance of
Merck, known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd., have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. Phase III clinical studies in type 1 and type 2 diabetes will begin soon.
“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, diabetes, global human health, Merck. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease.”
“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide.”
Under the terms of the agreement, the companies will collaborate on clinical development, regulatory filings and manufacturing. If approved, Merck will commercialize this candidate. This collaboration builds on the agreement made by the two companies in February 2013 to develop and commercialize multiple biosimilar candidates.
Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, aims to develop affordable and high-quality biopharmaceutical and biosimilar products.
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.
The US health regulator plans to conduct workshops across India in the next one year in order to sanitise Indian drug companies about the changing quality requirements in the American market.
- In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.
- In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.
NEW DELHI: The campaign to bring all clinical trial data into the public domain got a shot in the arm with Johnson & Johnson making all its drug trial data available to Yale University.
J&J is the first company to hand over all its trial data to a completely independent third party, the Yale University Open Data Access (YODA) project. Pharma giants like GSK, Pfizer and Roche had earlier announced that they would make their trial data available, but only on their own web portals where researchers would have to apply to be given access to the data. Harlan Krumholz, principal investigator on the YODA project has stressed that YODA’s advantage lay in its credibility as an independent body that would not impede access to data, but would ensure its responsible use.
The slow and cautious opening up of clinical trial data to public scrutiny is the result of a long campaign that has insisted that all trials past and present ought to be registered and the full methods and results reported. The AllTrials project campaigned for all governments, regulators and research bodies to implement measures to achieve this. The project’s goal is “all trials registered, all results reported”.
Slowly but surely the screws seem to be tightening on the pharma companies to disclose trial data. Recently, the new clinical trial regulation, which would require anyone conducting a clinical trial to register it and publish a summary of results in a publicly accessible EU database, was approved by the Public Health Committee Members of the European Parliament. Under this regulation, full clinical study reports will have to be published after marketing authorization of the product or if the marketing authorization is withdrawn. These stipulations are to be enforced through fines on anyone who does not adhere to the new transparency rules.
Pharma has been fighting this move towards greater transparency. Last year in May, two pharma companies had sued to prevent European Medicines Agency from releasing clinical trial documents claiming that releasing the data would compromise ‘commercially confidential information’. The EMA argued that it did not consider clinical trial data to be commercially confidential . The case has moved to the General Court of the EU and in the meantime EMA cannot make public any document covered by the claim.
In a recent editorial in British Medical Journal, Dr Ben Goldacre, founder of the AllTrials campaign called for a routine audit of all currently used medical treatments. The audit is expected to identify if the clinical trials on which the treatment is based were registered, what trial and research data was available, which company manufactured the drug and who were the investigators involved in the R&D. This data is expected to help identify the best and worst treatments, companies, researchers and inform patients and doctors before making all-important life-or-death decisions.
According to the AllTrails website, thousands of clinical trials have not reported their results and some have not even been registered. “Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine and trials being repeated,” stated the AllTrials website.
Glen Willmott, the UK MEP was quoted as saying that for too long, unflattering studies on new medicines have gone undisclosed. “Around half of all trials are never published, usually with negative or disappointing results. It is vital that we know about negative outcomes—otherwise trials can be conducted repeatedly before it becomes public knowledge that some products are ineffective, or even dangerous,” said Willmott.
Source: Times of India