Page 372 - Health Medical Pharma
Dr Reddy's moves US court against stay on generic drug
Dr Reddy's Laboratories has filed a petition in the US Court of Appeals for the Federal Circuit against the preliminary injunction imposed by another US court preventing the Indian drug-maker from selling the generic Suboxone sublingual film in America. Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) is meant for the treatment of opioid dependence/addiction. The US Court of Appeals , which said it may hear the petition in the first week of October, had 'granted-in-part' themotion to expeditethe appeal of Dr Reddy's. Based ona petition of Indivior, a specialty pharmaceuticals business listed on the London Stock Exchange, the US court for the district of New Jersey, had, on July 13,granted the preliminary injunction on the launch of Suboxone by Dr Reddy's which has appealed against the ruling. Indiviorsaid itwould continue to defend its patent rights to the Suboxonefilm, including opposing Dr Reddy's appeal. Suboxone recorded sales of ...
Morepen Labs gets USFDA nod for 2 bulk drug units in HP
Drug firm Morepen Laboratories today said it has received approval from the US health regulator for two bulk drug facilities in Himachal Pradesh manufacturing Atorvastatin Calcium and Montelukast Sodium, respectively. While the Baddi facility has got US Food and Drug Administration (USFDA) nod to manufacture cholesterol reducing bulk drug Atorvastatin Calcium, the Masulkhana facility has received approval for manufacturing anti-asthma bulk drug Montelukast Sodium, Morepen Laboratories said in a filing to BSE. "The US market size for these two bulk drugs viz. Atorvastatin Calcium and Montelukast Sodium is approximately Rs 5,000 crore and Rs 2,000 crore, respectively," it added. The two active pharmaceutical ingredients (APIs) collectively constitute 44 per cent of the company's total API business, Morepen Laboratories said. Commenting on the development, Morepen Laboratories Chairman and MD Sushil Suri said, "With this development in place, the company is set to expand its foothold in .
Sharif's hospital ward in PIMS declared sub-jail
Ailing Nawaz Sharif's hospital ward has been declared as a sub-jail, a day after Pakistan's former prime minister was admitted to the premier Pakistan Institute of Medical Sciences following health complications, a media report said today. Sharif, 68, was yesterday shifted to the Cardiac Centre of the country's top hospital in Islamabad after his health deteriorated due to heart trouble in the Adiala Jail in Rawalpindi. He is said to be in a stable condition, a hospital official said last night. The three-time Pakistan premier is serving a 10-year jail term in a corruption case over his family's purchase of luxury apartments in London. He has been lodged in the Adiala Jail since July 13. "A notification issued by the office of the Islamabad chief commissioner yesterday said that the capital city's administration had decided to declare premises of the PIMS Cardiac Centre's private ward as 'sub-jail' for keeping Nawaz Sharif, convicted prisoner in NAB case, with immediate effect," Dawn .
Chinese parents stage rare public protest over vaccine scare
About a dozen people held a rare protest outside China's Health Ministry to demand action over a vaccine scandal that has inflamed public fears over the safety of domestically produced drugs. Video clips of the daring demonstration in front of the ministry were widely circulated on Twitter and other social media today, showing the protesters holding banners urging accountability and justice in the latest case. "Legislation for vaccines is imperative! Handle this properly and responsibly!" they shouted in the footage. Social media posts said the demonstration took place on today but AFP was unable to independently confirm that. The fate of the protesters, whose banners described them as parents, was not known. An AFP journalist who arrived later at the location found no one there. Chinese security personnel typically react quickly to shut down public expressions of dissent, often detaining those involved. China's latest product-safety scare emerged more than a week ago with news that ..
Aurobindo Pharma sweetens after USFDA nod
Aurobindo Pharma rose 2.11% to Rs 603.70 at 14:55 IST on BSE after the company said it received final approval from the USFDA to manufacture and market Bivalirudin injection, 250 mg/vial.
Healthy diet may lower cancer risk: Study
Adhering to a healthy diet, drinking less alcohol, and exercising may reduce the risk of developing cancer, researchers have found. The review, published in the journal Cancer Research, drew data from the NutriNet-Sante study, launched in 2009 to investigate associations between nutrition and health in a French cohort. This study included a large sample of 41,543 participants aged 40 or older, who had never been diagnosed with cancer prior to inclusion in the study. "The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) estimated that in developed countries, around 35 per cent of breast cancers and 45 per cent of colorectal cancers could be avoided by adherence to nutritional recommendations," said Bernard Srour from Paris 13 University in France. The WCRF/AICR recommends plenty of whole grains, fruit, vegetables, and beans with limited fast food, red and processed meat, alcohol, and sugary drinks. The study showed that adherence to nutritional ...
Twin USFDA approvals for Morepen Labs' bulk drugs (API) facilities
Morepen Laboratories Ltd. has received US FDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing facilities situated in Himachal Pradesh.While the Baddi facility has got US FDA approval for the manufacture of bulk drug "Atorvastatin Calcium", a Cholesterol reducing drug, the Masulkhana facility has recently got the nod for manufacturing an anti-asthma bulk drug "Montelukast Sodium" for export to the US market.It is significant to note here that the US market size for these two bulk drugs viz. Atorvastatin Calcium and Montelukast Sodium is approximately Rs. 5,000 crore and Rs. 2,000 crore respectively. The two APIs collectively contributes around Rs. 150 crore annual revenue to the company's top line and constitutes 44 per cent of the company's total API business.The main API facility situated at Baddi (Himachal Pradesh) houses multiple plants for manufacture of different drugs, including Atorvastatin, and is spread across an area of around 50 .
Digestive acids may help treat cocaine abuse
Bile acids - that help us digest fat - can help treat cocaine addiction by influencing the brain's reward system, according to a study that paves the way for new therapies against substance abuse. Researchers from Vanderbilt University in the US first showed that surgery produced an elevation of bile acids in the brain, resulting in a reduction in dopamine release in response to cocaine. Bile acids are normally released from the gall bladder into the upper part of the small intestine, where they emulsify fats for absorption, before being recycled further down the small intestine. In bile diversion surgery, an experimental treatment for weight loss, bile is released at the end of the small intestine, increasing the amount of bile acids that enter the general circulation. Mice treated with this surgery have less appetite for high-fat foods, which suggests that bile acids affect brain reward pathways. They also showed less preference for the cocaine-associated chamber, indicating that ...
KMC Doctors first to identify a rare blood group 'P Null' phenotype in India
A team of doctors led by Dr. Shamee Shastry from the blood bank of Kasturba Medical College, Manipal identified a rare blood group called 'pp' or 'P null' phenotype. ABO and Rh D are the commonly typed blood group systems.However, there are more than 200 minor blood group antigens known besides A, B and Rh. A blood type is considered rare if fewer than 1 in 1,000 people has it. A person is said to have rare blood group when he lacks the high-frequency antigen or multiple common antigens.The Blood Bank at Kasturba Hospital received samples from a patient who required an urgent blood transfusion. The doctors were unable to find a compatible blood unit even after cross-matching with more than 80 units. Extensive immunohematology workup was performed by the blood bank team and further, for confirmation, samples were referred to the International Blood group Reference Laboratory (IBGRL), Bristol, UK for serological testing. With the help of a reference laboratory, it was confirmed that the
Zydus Cadila gets USFDA nod to market Vardenafil tablets
Drug firm Zydus Cadila today said it has received tentative approval from the US health regulator to market Vardenafil Hydrochloride tablets used for treatment of erectile dysfunction in the American market. The company said in a statement that it has received nod from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg. The product will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, it added. "The drug is an erectile dysfunction agent that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction," Zydus Cadila said. The group currently has 212 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company, it added. Shares of Cadila Healthcare, the listed entity of the group, were trading over 2 per cent up at Rs 380.55 on BSE in the afternoon.
Nod for Aurobindo Pharma to make, market Bivalirudin injection
Aurobindo Pharma Limited today said it got the approval of the US Food and Drug Administration (USFDA) to manufacture and market Bivalirudin injection of 250 mg/vial. In a press release here, Aurobindo Pharma Ltd said the drug was a generic equivalent to the Angiomax injection. The Bivalirudin injection was being used as an anti-coagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty among others, the release said. The drug was intended for use with aspirin, it said. Citing market reports, the release said the estimated market size of the Bivalirudin injection was USD 101 million for the year ending May 2018. The product would be launched in September 2018, the release said.
Govt to look into pulse import in which Glyphosate used
Food Minister Ram Vilas Paswan today said he would look into the import of pulses in which Glyphosate herbicide has been used. During Zero Hour in the Lok Sabha, BJD's Bhartruhari Mahtab raised the issue of import of pulses in which Glyphosate, which is harmful for humans, has been used. Mahtab demanded that the import policy should be strict to ensure that public health is protected. Replying to Mahtab, Paswan said "we will look into it and in no way, the health of the public would be put at risk".
Wockhardt sets up its first manufacturing facility in Middle East
Drug firm Wockhardt has set up its first facility in the Middle East in Dubai for manufacture of new chemical entities (NCEs) to cater to global markets. The facility is spread over 10,000 sq meters, self-sufficient for handling warehousing, manufacturing operations, product testing and product stability, Wockhardt said in a statement. "With the new facility in the Middle East, we aim to focus on our commitment to developing NCEs to fight the health issues," Wockhardt Founder Chairman Habil Khorakiwala said. Wockhardt is poised for a quantum leap into the future, he added. The company however did not provide any details about the investments it has made for setting up the facility. "With Wockhardt's commitment to research and development, we have 5 breakthrough NCEs that have been accorded Qualified Infectious Disease Product (QIDP) status by USFDA," Khorakiwala said. The five novel antibiotic drugs are in advanced stage of global clinical development, the company said. "Wockhardt has
Socialising boosts wellbeing in dementia patients
Just ten minutes of meaningful social interaction can improve wellbeing in dementia patients, a study has found. The average person with dementia in a care home experiences just two minutes of social interaction each day. Researchers also showed that out of 170 available training programmes for nursing home staff, only three are evidence-based - none of which improve quality of life. An e-learning programme that trains care home staff to engage in meaningful social interaction with people who have dementia improves wellbeing and has sustained benefits, they found. The Wellbeing and Health for people with Dementia (WHELD) programme trained care home staff to increase social interaction from two minutes a day to ten, combined with a programme of personalised care. It involves simple measures such as talking to residents about their interests and involving them in decisions around their care. The study, conducted by the University of Exeter and King's College London in the UK involved ...
Aurobindo Pharma receives USFDA final approval for Bivalirudin Injection
The estimated market size of Bivalirudin injection is US$ 101 million for the twelve months ended May 2018 according to IQVIA. The product will be launched in September 2018.
Football effective for old diabetic patients
Turns out, playing football helps increase the bone strength of diabetic patients (male and female) between 55 to 70 years.Individuals with prediabetes and type-2 diabetes have a higher prevalence of osteopenia. A recent study confirmed that football is effective for osteogenic training and that it has significant positive effects in the legs and clinically important femoral sites.In the study, Dual-energy X-ray absorptiometry (DXA) scans were used to evaluate the initial bone health of the participants as well as the training-induced effects, along with blood samples to determine plasma markers for bone turnover and bone formation.From these measurements, 73 percent of the participants were diagnosed with femoral osteopenia and 24 percent with femoral osteoporosis prior to the intervention.After 16 weeks of training, between-group changes in favour of football training were observed for the bone mineral content of the femoral neck (3.2 percent) and femoral shaft (2.5 percent) as well
Magnetic kyphoplasty can now heal spinal fractures
Adding magnetic particles to surgical cement can now heal spinal fractures. Patients with spinal fractures caused by tumors or osteoporosis usually undergo a procedure called kyphoplasty, where the fracture is filled with surgical cement.While kyphoplasty does stabilize the bone but when it comes to cancer patients, they are left with spinal column tumors that are very hard to reach with conventional chemotherapy, since the blood-brain barrier has to be crossed when delivered intravenously.In a recent study, it was confirmed that by adding magnetic particles to surgical cement used to heal spinal fractures, could guide magnetic nanoparticles directly to lesions near the fractures.Nanoparticles bound to various drugs have been used to target drugs to specific locations or types of cells in the body. Most commonly, this is achieved by binding a minute amount of drug to the nanoparticle, which is designed to also bind to a specific type of cell, such as a cancer cell."By modifying the ...
Karunanidhi's condition continues to be stable
DMK President M. Karunanidhi's health condition is stable and his vital signs are normal on Monday, said a party spokesperson.
Karuna continues to be under intensive care; TN CM visits him
DMK president M Karunanidhi is stable and continues to be treated at the ICU of a hospital here for the third consecutive day as Tamil Nadu Chief Minister K Palaniswami and his deputy O Panneerselvam visited the hospital to enquire about the leader's health. Palaniswami after visiting Karunanidhi at Kauvery Hospital told reporters that the DMK chief's health condition is "stable...he is well...a medical team is attending on him... Me and deputy chief minister O Panneerselvam along with DMK party working president M K Stalin and Rajya Sabha MP Kanimozhi visited him in person." State ministers including Law minister C Ve Shanmugam accompanied the Chief Minister to the hospital. Last night, a medical bulletin issued by Kauvery Hospital said: "There was a transient setback in the clinical condition of DMK president M Karunanidhi. With active medical support his vital signs are normalising. He continues to be closely monitored and treated by the panel of expert doctors," A medical bulletin
Zydus receives USFDA tentative approval for Vardenafil Hydrochloride Tablets USP
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