Page 101 - Health Medical Pharma
Cipla update on USFDA inspection of its Kurkumbh plant
Post the conclusion of the inspection, the Company received 8 GMP observations. The Company also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024.
Dr Reddys Laboratories settles legal proceedings with Celgene for its Canadian patents related to Lenalidomide
Pursuant to this confidential settlement, the parties agreed to discontinue all legal proceedings involving certain of Celgene's Canadian patents related to Lenalidomide and the Company's ANDS for a generic versions of Celgene's Lenalidomide capsules pending before Health Canada. Other terms of the agreement are confidential.
Strides Pharma receives USFDA approval for Potassium Chloride ER Tablets USP 750mg, 1125 mg and 1500 mg
According to IQVIA MAT data, the US market for Potassium Chloride Extended Release Tablets with the current reference product is approximately US$ 240 Mn. The product will be manufactured by Pii and will be marketed by Strides in the US market. Strides already has an approval for Potassium Chloride Extended Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) which is a generic version of Klor-Con Extended Release Tablets of Upsher-Smith. The two approvals taken together will help company address a combined opportunity of US$ 300 Mn per annum, representing ~ 90% of the Potassium Chloride Extended Release tablet market in the US.
Wearable sensors mimic skin to help wound healing
Scientists have developed sensors that can mimic the skin and monitor wounds in real-time, helping them heal faster. Biosensors are analytical devices that combine a biological component with a physiochemical detector to observe and analyse a chemical substance and its reaction in the body. Conventional biosensor technology, while a great advancement in the medical field, still has limitations to overcome and improvements to be made to enhance their functionality. Researchers at Binghamton University in the US have developed a skin-inspired, open-mesh electromechanical sensor that is capable of monitoring lactate and oxygen on the skin. "We eventually hope that these sensors and engineering accomplishments can help advance healthcare applications and provide a better quantitative understanding in disease progression, wound care, general health, fitness monitoring and more," said Matthew Brown, a PhD student at Binghamton University. Researchers designed a sensor that is structured ...
Zydus Cadila gets tentative USFDA nod for overactive bladder treatment drug
Drug firm Zydus Cadila Tuesday said it has received tentative nod from the US health regulator to market its Mirabegron extended-release tablets. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market generic Mirabegron extended-release tablets in the strengths of 25 mg and 50 mg, Zydus Cadila said in a statement. The product will be manufactured at the group's manufacturing facility at SEZ in Ahmedabad, it added. The tablets are generic version of Myrbetriq extended-release tablets, Zydus Cadila said. The product is used for the treatment of overactive bladder, a chronic condition of the lower urinary tract characterised by symptoms of urinary urgency, with or without urge incontinence, it added. The group now has 259 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, the company said. Shares of Cadila Healthcare, the listed entity of the group, were
Heavy alcohol use may slow brain growth: Study
Heavy use of alcohol may slow the rate of growth in developing brains, according to a study conducted in monkeys. The study, published in the journal eNeuro, shows that heavy alcohol use reduced the rate of brain growth by 0.25 millilitres per year for every gramme of alcohol consumed per kilogramme of body weight. In human terms, that is the equivalent of four beers per day, said researchers from the Oregon Health and Science University in the US. "Chronic alcohol self-intoxication reduced the growth rate of brain, cerebral white matter and subcortical thalamus," researchers said in a statement. They measured brain growth through magnetic resonance imaging of 71 rhesus macaques that voluntarily consumed ethanol or beverage alcohol. The researchers precisely measured intake, diet, daily schedules and health care, thus ruling out other factors that tend to confound results in observational studies involving people. The findings help validate previous research examining the effect of ...
Tobacco use makes precancerous cells that fertilize cancer growth, study suggests
A recent study has found that tobacco consumption leads to the formation of precancerous cells that fertilize cancer growth.There have been a lot of studies dedicated to cancer-related topics, exactly how this precancerous field influences cancer has been often overlooked.As part of the study, the researchers wanted to understand how these precancerous cells may impact neighboring cancer. The study explores this communication between precancerous and cancer cells in the context of an enzyme called PI3K.The enzyme PI3K is activated in many or even most cancers, with some researchers considering PI3K over-activation an essential feature driving the disease. Attractively, PI3K is a "kinase" and the class of drugs known as kinase inhibitors has proven effective against a host of cancer types.Kinase inhibitors have been developed against PI3K as well, and by and large they do a lovely job of killing cancer cells in dishes. The ongoing question has been why PI3K inhibitors do not ...
Long, stressful commutes harmful for pregnant women: Study
Pregnant women who commute long-distance to work have an increased risk of adverse birth outcomes, including having babies born at a low-birth-weight, a recent study suggests.An analysis of data gleaned from 2014 and 2015 New Jersey birth records, revealed that for pregnant women who commute at least 50 miles to work, each ten miles of travel distance increased the probability of having a low birth weight baby by nearly one percentage point (0.9) or 14 percent, compared to the national average. In other words, the longer the long-distance commute, the higher the risk for giving birth to a low birth weight infant (Low birth weight is defined as under 2,500 grams or about 5.5 pounds).For every ten miles or travel distance added to a long commute, the probability of having intrauterine growth restriction increased by 0.6 percentage points or 43 percent, compared to the average rate among pregnant women living within 10 miles of their workplaces.The researchers attribute the higher risk ..
Strides arm and its partner get USFDA nod for hypokalemia treatment drug
Drug firm Strides Pharma Science Tuesday said its step-down wholly-owned subsidiary Vensun Pharmaceuticals, Inc., USA, and its partner Pharmaceutics International, Inc. (Pii), have received approval from the US health regulator for jointly developed Potassium Chloride extended-release tablets. The United States Food and Drug Administration (USFDA) has approved the product in the strengths of 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg), Strides Pharma Science said in a regulatory filing. The approved product, used in treatment of patients with hypokalemia, is a generic version of Merck, Inc's Potassium Chloride extended-release tablets, it said. Quoting IQVIA MAT data, Strides Pharma Science said the US market for Potassium Chloride extended-release tablets is approximately USD 240 million. The product will be manufactured by Pii and will be marketed by Strides in the US market, it said. Shares of Strides Pharma Science were trading 0.26 per cent higher at Rs 477.60 ...
Dr Reddy's settles case with US-based Celgene related to cancer drug
Dr Reddy's Laboratories Tuesday said it has entered into a confidential settlement agreement with the US-based biotechnology firm Celgene for its abbreviated new drug submissions (ANDS) related to a generic version of REVLIMID brand capsules pending before Health Canada. REVLIMID (Lenalidomide) is indicated for treatment for multiple myeloma (cancer). "Pursuant to this confidential settlement, the parties agreed to discontinue all legal proceedings involving certain of Celgene's Canadian patents related to Lenalidomide and the company's ANDS for a generic version of Celgene's Lenalidomide capsules pending before Health Canada," Dr Reddy's said in a BSE filing. Dr Reddy's Laboratories said other terms of the agreement are confidential. Shares of Dr Reddy's Laboratories were trading 0.06 per cent lower at Rs 2,789.40 apiece on the BSE.
Lupin gets EIR from USFDA for Pithampur unit
Drug major Lupin Ltd Tuesday announced receipt of the Establishment Inspection Report (EIR) from the US health regulator for its Pithampur facility in Madhya Pradesh. The US Food and Drug Administration (USFDA) gives EIR on closure of inspection of an establishment that is the subject of an USFDA or USFDA-contracted inspection. "The inspection was conducted between October 8, 2018 to October 18, 2018," the company said in a BSE filing. Lupin said its Pithampur Unit-3 facility is involved in the manufacture of metered dose inhalers (MDis), dry powder inhalers (DPis) and topical formulations for the regulated markets. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, "Receiving the EIR for our Pithampur Unit-3 facility is a very positive development and brings us one step closer to bringing important MDis and DPis to the market. We are committed to ensuring the quality, safety and efficacy of the products that we manufacture across our facilities." Shares of ...
McDowell's water banned in J&K after e-Coli found
Jammu and Kashmir's Food Commissioner has banned the sale and supply of McDowell's packaged drinking water in the state after the detection of E. coli bacteria in it.
US govt's CDC modifies advisory against travelling to India
The US government's Centre for Disease Control and Prevention (CDC) has modified its advisory against travelling to India which it had issued after zika cases were reported in Rajasthan and Madhya Pradesh. The Indian government had urged the US to "withdraw or modify" its advisory in January by providing evidence of the contained outbreak in the country. Director General of Indian Council of Medical Research (ICMR) Dr Balram Bhargava in his communication also provided data on human and vector surveillance for zika virus disease in India. "The communication was successful in ensuring modification of the travel advisory on March 27, 2019. The status of India has now been changed from 'ongoing outbreak' to 'current or past transmission but no current outbreak'," the ICMR in an official statement said. It said the zika virus strain isolated from Rajasthan matches with the Brazilian zika strain associated with outbreaks, and microcephaly/Congenital Zika Syndrome (CZS) and that the ICMR-NIV
Cipla signs $22 mn pact with Pulmatrix Inc for new asthma drug
Domestic pharma major Cipla Monday said it has signed a binding agreement with Pulmatrix Inc for co-development and licensing opportunity for a new drug under development for an upfront consideration of USD 22 million. The agreement has been signed between the company's wholly-owned subsidiary in the US, Cipla Technologies LLC with Pulmatrix Inc for an investment in phase 2 ready Pulmazole (inhaled ltraconazole). Pulmazole is an inhaled anti-fungal formulation of itraconazole aimed at treating allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. Cipla said, "Entry into a definitive agreement is contingent upon Pulmatrix raising additional funds from the market". Upon signing the definitive agreement, the co-development cost towards development and the total free cash flow in relation to commercialisation of Pulmazole will be further shared by both the parties in a phased manner, it added.
High insulin in newborns ups brain damage risk
Babies born with abnormally high levels of insulin are at the risk of suffering permanent brain damage and life-long disability, finds a study that showed it's possible to predict when and how the condition may affect the child in the long-term.
New research identifies neurons that drive and quench salt cravings in mouse brain
People who like salty foods take note! New research has identified neurons that drive and quench salt cravings in the mouse brain. The findings are an entry point into regulating sodium cravings in humans.The paper describing the research appeared online ahead of publication in the journal Nature.Eating too much salt has potential health risks and can lead to cardiovascular and cognitive disorders. The work was done in the laboratory of Yuki Oka, assistant professor of biology and Chen Scholar.Sodium, an ion found in table salt, plays a critical role in various body functions, such as cardiovascular activity, fluid balance, and nerve signalling. In every animal species, the body strictly regulates and maintains sodium levels.Because animals cannot metabolically create sodium themselves, the ions have to be ingested from external food sources. When the body is low on sodium, the brain triggers specific appetite signals that drive the consumption of sodium.Though the mechanisms of these
45 million Indians suffer from heart ailments
Of the estimated 1.30 billion population of India, around 45 million suffer from heart ailments, which gives the country an odd distinction of having the highest number of cardiovascular disease cases in the world, according to a renowned cardiologist.
Scientists discover new prospect of treating autism
Chinese scientists have discovered that absence of a certain protein in flies causes intestinal flora imbalance and makes them show symptoms similar to autism in humans.
'Wearable' device captures cancer cells from blood
Scientists have developed a wearable device that can continuously collect live cancer cells directly from a patient's blood, paving the way for doctors to diagnose cancer without conducting biopsies. Tumours can release more than 1,000 cancer cells into the bloodstream in a single minute. Current methods of capturing cancer cells from blood rely on samples from the patient -- usually no more than a tablespoon taken in a single draw. Some blood draws come back with no cancer cells, even in patients with advanced cancer, and a typical sample contains no more than 10 cancer cells. "Nobody wants to have a biopsy. If we could get enough cancer cells from the blood, we could use them to learn about the tumour biology and direct care for the patients," said Daniel F Hayes, a professor at the University of Michigan in the US. Over a couple of hours in the hospital, the device could continuously capture cancer cells directly from the vein, screening much larger volumes of a patient's blood. In
New wearable device grabs cancer cells from blood
A team of US engineers have developed a prototype wearable device that can continuously collect live cancer cells directly from a patient's blood in an advance that could help patients avoid biopsy as well as get treatment for cancer more effectively.