Philips India offers 2 affordable, pocket-sized diagnostics for cardiac & maternal emergencies

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Philips India has now stirred a price war in the healthcare life-saving diagnostic equipment space offering its pocket-sized ECG and ultrasound at 50 per cent lower than those available in the market. This led the company to commence discussions with the state governments and convince them to opt for affordable healthcare diagnostics to help save lives of patients in the event of a cardiac and maternal  emergency and save lives.

The basic model of ECG-100  is priced at Rs. 25,000 and ultrasound VISIQ is Rs. 10.5 lakh . The big advantage is that two equipments are pocket sized convenient for any general practitioner to carry during a health emergency. It could also be handled with ease by a paramedic at primary healthcare centres in remote areas.

The two products designed and developed at the Phillips Innovation Centre (PIC) in Bengaluru which is one among its key R&D locations of the 59 research centres globally.

India currently has 1050 cardiac centres. The country accounts for 60 million people with  cardiovascular disease (CVD) and 6 million fatal cases.  In the last ten years, CVD went up from 36 million to 60 million. The answer to this problem is preventive and screening to detect CVD.  The number of Maternal mortality is also a serious issue. Therefore, every public and private healthcare centre in the country needs the two equipment which are dependable, simple-to-use and affordable, said Ravi Ramaswamy, senior director, head, Healthcare, Philips Innovation Centre.

“We have initiated our talks with the state governments including Punjab and Karnataka which are now assessing and analysing the two equipment, Jitesh Mathur, senior director, PCCI, Reach Strategic Key Accounts, Philips Healthcare, told Pharmabiz

In fact the innovation in the ECG is its sophisticated transducer which can be  connected to an Android- based tablet smartphone, added Mathur.

In the case of the ultrasound VISIQ, the equipment is a compact single miniaturised device allowing Ob/Gyn specialists to scan expectant women  not just in labour rooms but in remote areas to prevent maternal mortality, said Sujit Kumar, general manager, Ultrasound, Philips Healthcare.

“India and other growth geographies are increasingly important, as centres of innovation excellence for us. This is a fundamental part of our innovation strategy particularly in healthcare where we continue to invest in centres of excellence having a  global presence and local relevance. PIC is one of the 59 Philips R&D centres globally, of which 13 are in Asia and 3 in Latin America.  In 2013, Philips invested over  EUR 1.7 billion in research and development globally,”  said Jim Andrew, Chief Strategy & Innovation Officer .

According to Krishna Kumar, vice chairman and managing director, Philips India, both ECG and ultrasound are here to address the complex challenges of India healthcare.

Source: PharmaBiz


FDA approves new hand-held auto-injector to reverse opioid overdose

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First naloxone treatment specifically designed to be given by family members or caregivers

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose. Family members or caregivers should also become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed.

Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.

In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe. The use of Evzio in patients who are opioid dependent may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures and cardiac arrest.

The FDA reviewed Evzio under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The product was granted a fast-track designation, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.

Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. The FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.

Evzio is manufactured for kaléo, Inc., of Richmond, Va.

Source: USFDA

IPA wants govt to create National Council for Pharmaceutical Research

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A resolution passed by the general body of the Tamil Nadu branch of the Indian Pharmaceutical Association (IPA) has demanded that government of India should soon take steps to set up a national council for pharmaceutical research, which should be known as Indian Council for Pharmaceutical Research (ICPR).

Presenting the resolution in the meeting, Dr Thirumalai Elango, the Registrar of Tamil Nadu Pharmacy Council said there are several significant national councils for various industrial and medical researches.  Indian Council for Agricultural Research (ICAR), Indian Council for Medical Research (ICMR), Indian Council for Ayurvedic Research (ICAR), Indian Council for Siddha Research (ICSR), Indian Council of Unani Research (ICUR), Indian Council for Naturopathy Research (ICNR), Indian Council for Scientific Research (ICSR)..etc are some examples.  Unfortunately, the government of India has so far not created a Council for Pharmaceutical Research, he said in his resolution.

Citing examples, Dr Elango said the only industry in the country which is recession proof  is the pharmaceutical industry and is growing  at a rate of 15 per cent every year. With the dynamic growth of the industry, India is called the ‘pharmacy for the rest of the world’. Our country exports medicines to  more than 220 countries. Other than medicine no other product is exported like this. Even then, the government has so far not given due recognition to the pharmaceutical industry, he added.

Later the meeting passed another resolution that like medical, engineering and agricultural subjects, pharmacy subjects like pharmaceutics, pharmaceutical chemistry, pharmacognosy and forensic pharmacy should be included in the Group 1 Examinations conducted by the Union Public Services Commission (UPSC). Inclusion of pharmacy subjects will enable the pharmacy graduates to appear for the national competitive examinations and to get into public administration on par with medical, engineering and agricultural graduates.

A third resolution presented in the meeting demanded the creation of a separate ministry for pharmacy and pharmaceuticals.  It said that at present the pharmacy profession is controlled by many ministries like health ministry, ministry of petroleum & chemicals, ministry of commerce, ministry of forests, etc. The pharmacy education is under health ministry and under the higher education ministry (PCI & AICTE). The drugs control administration comes under ministry of health. Pharmaceutical industry comes under ministry of industry & commerce. Pollution control is controlled by ministry of environment & forests. Too many ministries to control a single pharmacy profession is not advisable and helpful for development.   So the government should create a Ministry of Pharmacy and Pharmaceuticals, demanded the resolution.

All the three resolutions were passed unanimously by the general body.

Source: PharmaBiz

ICMR to begin research on communicable disease in North East

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The Indian Council of Medical Research (ICMR) will soon begin research in communicable diseases including vector borne diseases, viral diseases, HIV/AIDS and drug abuses, bacterial infections, diarrhoeal diseases and parasitology in the north eastern region of the country.  The research programme is aimed to cater to the health problems of north east India.

The focus of this research programme is primarily to conduct translational research so as to cater to the health problems of north east India for the benefit of people and public health welfare. The principal investigator (PI) must be from the north-east region of India.

The initiative taken by the ICMR in this regard is significant as the north-east India shares international borders with neighbouring countries like Bhutan, China, Myanmar and Bangladesh, and being a gateway to South East Asia, attains a specific importance to various problems due to various well established, emerging and reemerging communicable diseases and cross border transmission.
Epidemiology and Communicable Disease Division of the ICMR has invited concept proposals in communicable disease research in north east from scientists on priority areas of research in north-east India.  The last date for submission of concept proposals is May 20, 2014.
Under the vector borne diseases, the focus of the research will be on diseases like malaria, filaraisis, Japanese encephalitis (JE), dengue, chikungunia, West Nile Virus and resurgence of kala azar as these are the most important mosquito borne parasitic and viral diseases prevalent in the north-eastern states.

The research programme is also focusing on viral diseases as Arunachal Pradesh is hyper-endemic for hepatitis B virus (HBV) infection with C, D and A and I circulating genotypes. High prevalence of Hepatitis C infection among injecting drug users in Manipur, Mizoram and Nagaland states has also been reported. In addition to hepatitis, among the viral diseases, sexually transmitted and respiratory infections are also very common in this part of the country.
The programme will also focus on HIV/AIDS and drug abuse; bacterial infections; diarrhoeal diseases and parasitological diseases which may be developed into full ad hoc proposals on approvals.
Under this north-east initiative, the principal investigator should identify the local problem, gaps in technology which need fortification and institutes outside the region with which collaboration would be useful.

The researchers should focus on the health problems of the north east region and the component of technology transfer should be inbuilt in all collaborative projects where one of the institutions is from outside the region. Other institutions including agriculture, IIT and universities could also apply for funding from ICMR provided there is a medical or public health benefits in the proposal. Such proposals could also be in the form of collaborative projects wherein the medical colleges can also be provided.

  Source: PharmaBiz

FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies

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grass pollen allergies

The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.

Allergic rhinitis with or without conjunctivitis are chronic diseases affecting children and adults. These allergic diseases affect approximately 30 million people in the United States and more than 500 million persons worldwide. These diseases are often caused by sensitivity to grass pollen. Affected people may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season. The first dose is taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions.
Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.
The safety and effectiveness of Oralair was evaluated in studies in the United States and Europe, involving approximately 2,500 people. Some patients received Oralair; others received an inactive substitute (placebo). To assess the effectiveness, patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one grass pollen season, patients taking Oralair experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo.
The prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Oralair also has a medication guide for distribution to the patient. The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.

Oralair is manufactured by Stallergenes S.A. of Antony, France.

Source: USFDA