US FDA approves GSK’s once-weekly type 2 diabetes drug, Tanzeum

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The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes.

Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle.

Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent. Vlad Hogenhuis, senior vice-president and head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said, “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”

The FDA approval of albiglutide is based on the results of GSK’s comprehensive phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.

Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014. Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan, for use in adult patients with type 2 diabetes.

Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Source: PharmaBiz


Minimum standards drafted for clinics under Clinical Establishment Act

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In a bid to effectively implement the Clinical Establishments (Registration and Regulation) Act 2010, the Union health ministry has announced draft minimum standards for various categories of clinical establishments, both in the allopathic and Indian streams of medicine.

Once approved, the registered establishments in the States where the Act is at present applicable should follow the minimum standards laid down separately for different kinds of clinics. The National Council for Clinical Establishments, the apex body under the chairmanship of Director General of Health Services, has held a series of consultations with the stakeholders including the Quality Council of India and Indian Medical Council to prepare the draft standards.

At present, States like Himachal Pradesh and Jharkhand, apart from the Union Territories of Andaman, Diu and Daman and Chandigarh have implemented the Act and over 4600 establishments had been registered.  States like Uttar Pradesh, Mizoram, Sikkim, Rajasthan and Arunachal Pradesh have also adopted the Act, but yet to implement them in the absence of rules, while the Centre is still trying to impress upon other States to adopt the same.

“The comments, suggestions, objections, including deletions/additions if required in the draft documents are invited from public at large, including the stakeholders like hospitals and other clinical establishments, consumer groups etc,” according to a notification by the Council.

The Indian Public Health Standards (IPHS) for sub-centre, PHC, CHC, sub-district/sub-divisional hospital and district hospitals have already approved documents. The draft is hence only for those in the private sector.

Separate standards have been prepared for allied health executive, behavioural health integrated counseling centres, dental centres, dental hospitals, dietetics, hospitals in primary, secondary and tertiary levels, labs, collection centres, mobile clinics, dialysis centres, physiotherapy centres, polyclinics with diagnostic support, polyclinic with dispensary,  polyclinic with observation, radiology and imaging centres and stem cell laboratories, in the allopathy sector.

Likewise, the detailed standard parameters have also been prepared in consultation with the Ayush department for establishments of Ayurveda, Naturopathy, Siddha, Sowa-rigpa, Unani and Yoga.

Source: PharmaBiz

Glenmark’s insomnia drug, eszopiclone tablets receives US FDA approval

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Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for eszopiclone tablets. Glenmark will commence distribution of the product immediately.

Eszopiclone tablets are Glenmark’s generic version of Sunovion’s Lunesta. Eszopiclone is indicated for the treatment of insomnia. The approval is for the 1mg, 2mg and 3mg tablets.

For the 12 month period ending December 2013, Lunesta garnered annual sales of USD 824 million according to IMS Health.

Source: PharmaBiz

Internet made interactions between doctors & patients challenging: Survey

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Easy access to online medical information has made interactions between doctors and patients challenging, according to the Physician Digital Outlook 2014 survey, jointly commissioned by Ipsos Healthcare and Ruder Finn. According to the Physician Digital Outlook 2014 survey, close to 50 per cent of Indian physicians believe that with increased availability of medical information to patients, through online media, they face huge difficulty in consulting their patients. With a robust sample of 650 physicians across metros, tier 1, tier 2 and tier 3 cities in India, the report investigated physicians’ online behaviour, use of digital and social media channels in the digital and mobile age. The surveyed physicians believe that 44 per cent of their patients are overloaded with medical information, 37 per cent patients perceive themselves as experts and 38 per cent are misinformed about their symptoms and disease. While face to face interactions with patients is still the most prominent method of consultation, phone calls and SMSes are now emerging as the more preferred options for doctors to communicate with their patients. Though, 93-98 per cent doctors use this mode to interact with their patients, 78 per cent of doctors connect over emails. The sample group for the survey covered general physicians, consulting physicians, paediatricians, dermatologists, diabetologists, endocrinologists, cardiologists, gynaecologists, radiologists, general surgeons, oncologists, nephrologists and intensivists. The study explores how emerging modes of information and communications have impacted the doctor-patient relationship,” said Mai Tran, executive vice president, Health & Wellness, Ruder Finn Asia. Dr. Bharat Shah, director, Global Hospital, Mumbai said that due to the widespread reach and usage of internet, there has been a truly phenomenal increase in easy availability of information. While it’s good to have access to internet for updating knowledge, most of the times a non-medical person is likely to get confused by it. It is not simple for patients to derive a correct interpretation of their health problems by simply reading viewing information on the internet.” “Patients access information about health conditions which they self-diagnose and then bring it up to their consulting physicians, have led the latter to spend additional time trying to correct the misinformation that the patients accumulate over time, said Dr. A.K. Jhingan, chairman, Delhi Diabetic Research Center. Monica Gangwani, executive director, Ipsos Healthcare, India, said that there is empowered patient and caregiver who want to seek clarity from the physicians regarding treatment. Physician Digital Outlook 2014 survey also revealed that Physicians from tier 1 cities are becoming internet savvy, and access it for 6 hours a day compared to other town classes while physicians from tier 2 cities have a slightly low usage of 3 hours per day, in comparison to their counterparts in metros.

Sources: PharmaBiz

Stem Cell Research Guidelines fix responsibility for investigators, institutions and sponsors

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The ‘National Guidelines for Stem Cell Research‘, issued recently by the Union health ministry, has fixed the responsibility for investigators, institutions and sponsors in the conduct of stem cell research in the country.

According to the Guidelines, the investigators and institutions where stem cell research is being conducted bear the ultimate responsibility of ensuring that research activities are in accordance with the national regulations and guidelines.  In particular, scientists whose research involves human ES cells should work closely with monitoring/regulatory bodies, demonstrate respect for autonomy and privacy of those who donate gametes, blastocysts, embryos or somatic cells for stem cell research, and be sensitive to public concerns about research that involves human embryos.

Those working with human iPS cells shall be particularly careful with the vectors and genes used for induction of stemness against malignant transformation. Sponsors shall also take note of their responsibilities and liabilities under various statutes, regulations and guidelines governing research and development in this field in the country.

As per the guidelines, each institution shall maintain a register of its investigators conducting stem cell research and ensure that all registered users are kept up to date with existing guidelines and regulations regarding the use of these cells. It shall also be the responsibility of the institution to ensure that most current standards are applied.  Each institution shall constitute an IC-SCR as provided in these guidelines and provide adequate support for its functioning. All records pertaining to clinical adult stem cell research must be maintained for a period of at least five years and those for ES/iPS cell research for atleast10 years.

The guidelines further explain that the physician/scientist engaged in stem cell research shall endeavour to avoid any activity that leads to unnecessary hype, or unrealistic expectations in the minds of study subjects or public at large regarding stem cell therapy. The study subject and other responsible family members must be given adequate and unbiased information about the trial protocol, its limitations and potential adverse effects. They must also be informed about the given indication for therapy. The investigator’s responsibility is to generate robust scientific evidence through good clinical trials which may then be applied for the benefit of the patients.

According to the Guidelines, the institutions conducting stem cell research shall establish suitable mechanisms for creating awareness and communicating scientific evidences to the public.  The basic scientists engaged in human stem cell research shall be vigilant to safeguard rights and dignity of human donors and aborted foetuses from whom samples for research have been obtained. The biological material should be treated with utmost respect and care in all experiments. The use of human embryos shall be restricted as much as possible, and shall be resorted to where there are no other alternatives. Also, special care should be taken in introducing human cells in animals, particularly in early developmental stages, which may lead to development of chimeras or incorporation into brain/gonads.

Source: PharmaBiz