The Japanese drug maker Otsuka Pharmaceutical won the approval for an upgraded version of Abilify, the antipsychotic drug first approved 15 years ago to treat schizophrenia, bipolar disorder, and depression. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.
Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. A resubmission of the new drug application was accepted by the agency in May 2017.
Mitchell Mathis, director of the Division of Psychiatry Products in the FDA'sCenter for Drug Evaluation and Research, said, "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients". Data from the tracker can be kept private for the patient alone to see, with the option to share data with healthcare professionals or other individuals, if desired.
Cheniere Energy Partners LP Holdings Llc (CQH) The company reported ($3.71) earnings per share for the quarter, missing the Zacks' consensus estimate of $0.48 by ($4.19). Tower Research Capital LLC TRC bought a new stake in shares of Cheniere Energy in the 2nd quarter worth about $121,000.
Caregivers and physicians can also be permitted by the patients to get the information via a web-based portal.
The drug regulator warns that Abilify MyCite should not be used for real-time tracking of drug ingestion or during an emergency as detection could be delayed or may not take place. Estimates suggest that 50% of patients with chronic conditions do not take their medications, costing the United States healthcare system upwards of $100 billion in avoidable costs. Among them, the FDA said it was important to note that Abilify MyCite's labeling asserts "the ability of the product to improve patient compliance with their treatment regimen has not been shown". The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.
In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may also occur.
Speaking to reporters Sunday, Trump said he will make a new announcement on trade when he returns to the United States. Secretary of State Rex Tillerson would attend the plenary session in his place, a senior White House official said.
On September 27, the finance minister had been indicted for possessing assets beyond his known sources of income. The NAB also moved an application seeking ratification of the seizure of more assets owned by the minister.
The firm has a ROI of 16.20%, calculating the gain or loss generated on investment relative to the sum of money invested. The existing P/E value will allow investors to easily determine whether the company's stock price is cheap or expensive.
On November 2 analysts at Susquehanna Bancshares updated its forecast on SIG by announcing an initial rating of "Neutral". The stock of Signet Jewelers Ltd. (NYSE:SIG) earned "Outperform" rating by RBC Capital Markets on Friday, August 26.
A guerilla war is going on between militants and Indian troops stationed in Indian-controlled Kashmir since 1989. Another soldier was injured in the fighting and was shifted to a hospital, the sources said here.
The present I-T raid is the longest in the history of raids in Tamil Nadu - usually, these raids last for about 2-3 days. Some reports suggest that the I-T officials had received inputs from the Finance Ministry's Financial Intelligence Unit.
The aerospace company reported $1.97 earnings per share (EPS) for the quarter, beating the consensus estimate of $1.90 by $0.07. Shares for $1.73 million were sold by Kennedy Thomas A . $235,017 worth of stock was sold by Wood Michael J on Monday, June 5.
The Bear Case for Newell Brands Inc. (NWL)
Their average price target spell out an upbeat performance - a 28% and would give NWL a market capitalization of almost $18.95B. Following the completion of the purchase, the director now directly owns 87,883 shares in the company, valued at $3,831,698.80.
Dawood Ibrahim's properties auctioned for Rs 11.58 crores
Shabnam Guest house, a double-storey structure in Yakub street which was occupied by Dawood's younger siblings- Haseena and Iqbal. However, past auctions of the gangster's properties drew a cold response from bidders, apparently due to "fear factor".
VS's son gets clean chit in IHRD appointment case
Irregularities were also alleged in his appointment to the ICT Academy and the Model Finishing Schools under the IHRD. Arun Kumar was appointed as assistant director of IHRD during the term of Nayanar Government's period.
The Best Cyber Monday Deals on Amazon
Store employees will hand out color-coded maps to help keep shoppers from getting too frazzled while searching for deals . It's beginning some online deals Thursday and plans to offer most of its Black Friday deals online starting at 12:01 a.m.
Trump to make statement on N
Trump's meetings with Putin are sure to color the tone and tenor of the Russian Federation investigation going forward. Trump's visit as "nothing but a business trip by a warmonger to enrich the monopolies of the USA defense industry".
Delhi: 18-month-old raped by father's friend in Shahpur Jat
Earlier on November 2, a one and a half years old girl was allegedly raped by a 33-year-old man in Delhi's Aman Vihar area. On Monday afternoon when the mother of the child returned home she saw her daughter bleeding from her private parts.
Fmr LLC Trims Stake in Crescent Point Energy Corporation (CPG)
The company reported $0.03 earnings per share (EPS) for the quarter, topping the Zacks' consensus estimate of ($0.07) by $0.10. Andra Ap owns 0.04% invested in Crescent Point Energy Corporation Ordinary Shares (Canada) (NYSE: CPG ) for 170,600 shares.
Kevin Harvick in Final Four in chase for NASCAR championship
When told that Harvick has picked Truex as the favorite, Truex cut off the question before waiting to hear what Harvick even said. Now, three former series champions and Truex, who has raced for the title in this format before, will compete for the title.
Pacific trade deal reached but leaders won't endorse it yet
Be proactive - Use the "Flag as Inappropriate" link at the upper right corner of each comment to let us know of abusive posts. Share with Us - We'd love to hear eyewitness accounts, the history behind an article, and smart, constructive criticism.