Health system can be strengthened by comprehensive changes to its building blocks: India at UN

Indias Deputy Permanent Representative Ambassador K Nagaraj Naidu stressed that there was a need to be cautious about commercialisation of health services, saying a strong public health system is needed to act as a guarantor.

By Yoshita Singh United Nations United Nations: India has said that the health system can be strengthened through comprehensive changes to policies, regulations and relationships across its building blocks that motivate positive changes in behaviour of service providers and users

Indias Deputy Permanent Representative Ambassador K Nagaraj Naidu stressed that there was a need to be cautious about commercialisation of health services, saying a strong public health system is needed to act as a guarantor. ....read more

Dengue Vaccine: The Asian Concerns

Health Minister Dr Harsh Wardhan told the parliament that India is near ready for the dengue vaccine. Let us know the facts -

Indian Scenario

1.A live attenuated vaccine known as Dengvaxia, developed by Sanofi, was licensed in 2015. Following this, long-term follow-up of the Sanofi phase III efficacy trial participants has revealed potential safety concerns. ....read more

Why retire at any age?

It has been a practice in India to retire people after the age of 58. In some cases, the age has been 60, 62, 65 or 70. Let us understand the science behind retirement.

• Retirement is based on the fact that after the age of 50, one starts developing age-related minimal cognitive impairment. One starts losing memory for immediate recall, recent memory, starts forgetting the names of common people and common places.
• Quite often, when one is speaking on a phone and his attention is diverted by someone, the person forgets what he was speaking. ....read more

Healthcare News Monitor

AuroMedics Pharma recalls over 59000 vials of antipsychotic injection in US

Business Standard – PTI

Aurobindo Pharma arm AuroMedics Pharma LLC is recalling 59.5 thousand vials of antipsychotic Fluphenazine Decanoate injection USP 125mg/5mL, (5 mL multiple dose vial) from the US market, the USFDA said. AuroMedics Pharma LLC is recalling 59,500 vials of the injection on account of "Discoloration; hazy solution found in one vial instead of a clear solution," the US heath regulator said in its latest Enforcement Report. The product was distributed to major wholesalers/distributors who may have further distributed the product throughout the US, it added. The voluntary ongoing recall is a class II recall, the United States Food and Drug Administration (USFDA) said. As per the regulator, class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". Fluphenazine Decanoate Injection, USP is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (for example chronic schizophrenics).

Cipla rises after associate firm submits NDA to USFDA for IV tramadol

Business Standard

Cipla advanced 1.77% to Rs 457.65 after associate firm, Avenue Therapeutics, announced submission of new drug application to the US drug regulator for intravenous tramadol. Ciplas associate company, Avenue Therapeutics, which majorly focuses on the development of intravenous (IV) tramadol for the U.S. market, announced that it submitted a new drug application (NDA) to the United States Food and Drug Administration (USFDA) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. IV tramadol is a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain. The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen. In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available. The announcement was made after trading hours yesterday, 11 December 2019.

FDA issues warning letter to Alkermes over opioid addiction treatment ad

ET Healthworld- Reuters

A print advertisement of Alkermes Plcs addiction treatment, Vivitrol, is false or misleading as it omits important risk information associated with its use, the Food and Drug Administration said in a warning letter to the company. Users of Vivitrol as a treatment for opioid dependence should be made aware of the vulnerability to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing the treatment, the agency said in the letter dated Dec. 2. Vivitrol, used to prevent a relapse to opioid dependence following detoxification and to treat alcohol dependence, is one of Alkermes top-selling drugs and brought in $85.2 million in the latest reported quarter. It blocks the effects of opioids for about 28 days after administration. But as the blockade wanes and eventually dissipates, patients may respond to lower doses of opioids than earlier, leading to potentially life-threatening intoxication, the FDA said. Cases of overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing the treatment, the agency said.

FDA grants breakthrough device designation to iLet Bionic Pancreas System

Medical Dialogues

iLet Bionic Pancreas System has received FDA’s (Food and Drug Administration) Breakthrough Device designation. The pocket-sized device, being developed by the biotechnology company Beta Bionics, autonomously controls blood sugar levels in patients with diabetes and other conditions. In a press release, the Company stated that the Breakthrough designation for the iLet Bionic Pancreas System “contemplates configurations with most insulin analogues approved for pumping.” The device is similar to an insulin pump however it only requires users to enter their body weight in order to initialize therapy in the system. It uses mathematical dosing algorithms based on home-use clinical trial results in adults and children with type 1 diabetes. The system can be configured to function as an insulin-only, glucagon-only, or a bihormonal bionic pancreas using insulin and glucagon. People with type 1 diabetes suffer from insulin deficiency and inappropriate glucagon secretion. Both hormones are essential to ensure stable and healthy blood glucose levels. “We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes,” said Beta Bionics president and CEO Ed Damiano in a press release. “We are particularly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.”