Preventing dangerous episodes of low blood sugar with diabetes

A new LSU Pennington Biomedical Research Center study reveals that a novel biomarker might give us new answers necessary to creating a diagnostic tool for hypoglycemia-associated autonomic failure, or HAAF. No objective diagnostic tool currently exists for this condition which, if left untreated, can lead to ever-worsening and possibly life-threatening episodes of dangerously low blood sugar.

Low blood sugar, or hypoglycemia, is a major complication of type 1 and type 2 diabetes. People with diabetes can have difficulty self-administering the exact insulin dose at the correct time to keep blood sugar levels in healthy ranges. If a low blood sugar episode occurs, individuals usually begin to feel a range of symptoms such as dizziness, headaches and nausea that trigger them to seek immediate, potentially life-saving, medical care.

But when people with diabetes have too many hypoglycemic episodes, their senses may become blunted. They may stop experiencing the physical symptoms that serve as cues to seek medical attention. They may not even realize they are having one or multiple hypoglycemic episodes until it is too late. This condition is more commonly known as hypoglycemia-associated autonomic failure (HAAF).

“There is currently no objective way for a health care provider to measure whether a patient has experienced repeated episodes of low blood sugar and therefore may be suffering from HAAF,” said David McDougal, PhD, assistant professor-research and head of Pennington Biomedical’s Neurobiology of Metabolic Dysfunction Laboratory. One-third of older adults with diabetes who had experienced a severe low blood sugar episode died within three years of the incident, according to a Johns Hopkins Bloomberg School of Public Health study.

LSU Pennington Biomedical researchers set out to discover ways that biomedical imaging might be able to offer new solutions as to how to measure exposure to glucose level crashes. They decided to focus not on glucose uptake in the brain directly, but on how the brain adapts following an episode of low glucose levels.

Blood glucose is the brain’s essential metabolic fuel. If glucose isn’t available because a person has hypoglycemia, the brain can adapt by increasing the rate at which it uses alternative energy sources, such as acetate.

“The results of our study suggest that this adaptation may still be present after exposure to times of low blood sugar and therefore can be used to measure how frequently a person experiences low blood sugar,” Dr. McDougal said. “We believe that by measuring how well a person’s brain uses acetate, we might one day be able to determine if they are suffering from HAAF or are at increased risk for developing the condition in the near future.”

This would allow doctors to provide treatment for reducing this risk by changing the medication the person takes or advising them to use a continuous glucose monitoring device, Dr. McDougal said.

The research significantly advances our understanding of the scope and importance of the relationship between brain metabolism and hypoglycemia, Dr. McDougal said. However, he cautions that “more studies will have to be conducted in order to demonstrate if this biomarker can be of practical clinical use.”

Dr. McDougal has filed a provisional patent application for his discovery.

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Story Source:

Materials provided by Louisiana State University. Note: Content may be edited for style and length.

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Journal Reference:

1. David Harry McDougal, Moses Morakortoi Darpolor, Marina Andreyevna DuVall, Elizabeth Frost Sutton, Christopher David Morrison, Kishore Murali Gadde, Leanne Maree Redman, Owen Thomas Carmichael. Glial acetate metabolism is increased following a 72-h fast in metabolically healthy men and correlates with susceptibility to hypoglycemia. Acta Diabetologica, 2018; DOI: 10.1007/s00592-018-1180-5

https://bit.ly/2mZeK4d

Wockhardt builds $40M plant in Dubai to produce ‘superbug’ fighters

India’s Wockhardt is working to develop antimicrobial drugs to fight the emerging threat of superbugs, and the company has built a $40 million manufacturing facility in Dubai to produce them.

The company announced Monday it has inaugurated a 10,000-square-meter (107,639-square-foot) facility in the Jebel Ali Free Zone in Dubai. The manufacturing and R&D project includes production of aseptic dry powder and filling, as well as warehousing, product testing and product stability.

It is being built to produce the novel antibiotics that Wockhardt is developing for sale globally. The company said it has five novel drugs that the FDA has granted Qualified Infectious Disease Program (QIDP) status.

“Wockhardt has dedicated significant resources for the discovery and development of these novel antibiotics, which are in advanced stages of development and are a culmination of 20 years of dedicated and focused research,” Murtaza Khorakiwala, Wockhardt managing director, said in a statement.

Health authorities around the world have been sounding an alarm for years that new antibiotics are needed to fight drug-resistant bugs that they no longer are able to routinely treat, and a number of companies have taken up the challenge.

Pfizer is among those. In 2016 it paid AstraZeneca $1.5 billion for its antibiotics portfolio and quickly followed up with the rollout of Zavicefta, an antibiotic that targets multidrug-resistant bacteria. It also has developed a database and mobile app that allows providers, and even consumers, to track pathogens and antibiotic treatments that work in their areas.

Last month, the FDA approved high-powered antibiotic Zemdri from Achaogen to treat drug-resistant urinary tract infections. It turned down the Bay Area biotech’s bid to use the new drug against bloodstream infections. The drug is “designed to retain its potent activity” when attacking difficult-to-treat infections resistant to multiple antibiotics, CEO Blake Wise said when the drug was approved.

https://bit.ly/2mW0h8Z

Fresenius continues to grow in 2Q, confirms outlook for 2018

• Healthy organic growth across the board, North American Products business continues strong growth
• Underlying Care Coordination margin improved
• Results continue to be impacted by strong currency headwinds
• Calcimimetics continue to evolve
• Divestiture of Sound Inpatient Physicians successfully closed
• NxStage acquisition expected to close in the second half of 2018

Key figures (IFRS)

EUR million	Q2 2018	Q2 2017	Growth yoy	Growth yoy, cc	H1 2018	H1 2017	Growth yoy	Growth yoy, cc
Revenue	4,214	4,471	(6%)	2%	8,189	9,019	(9%)	0%
Revenue on a comp. basis1	4,214	4,340	(3%)	5%	8,189	8,749	(6%)	3%
Revenue adjusted1	4,214	4,342	(3%)	5%	8,189	8,651	(5%)	4%
Operating income (EBIT)	1,401	583	140%	162%	1,898	1,235	54%	68%
EBIT on a comp. basis1	568	583	(3%)	4%	1,078	1,235	(13%)	(5%)
EBIT adjusted1	568	591	(4%)	2%	1,078	1,144	(6%)	3%
Net income2	994	269	270%	303%	1,273	577	121%	141%
Net income on a comp. basis1,2	308	269	15%	22%	599	577	4%	13%
Net income adjusted1,2	273	274	0%	6%	517	523	(1%)	7%
Basic EPS (EUR)	3.24	0.88	270%	303%	4.15	1.88	121%	141%
EPS on a comp. basis1	1.00	0.88	15%	22%	1.96	1.88	4%	13%
EPS adjusted1	0.89	0.89	0%	6%	1.69	1.71	(1%)	7%

cc = at constant currency, EPS = earnings per share

Rice Powell, Chief Executive Officer of Fresenius Medical Care, stated: ‘In the second quarter, we have seen solid growth resulting in a strong net income increase of 22 percent at constant currency – excluding the positive impact of the successful and efficient closing of the Sound Inpatient Physicians divestment. On the back of the strong development of our Products business and continued growth of our Services business, we expect growth to further accelerate in the second half of 2018.’

The company expects revenue³ growth between 5% and 7% at constant currency. Net income on a comparable basis⁴is expected to increase by 13% to 15% at constant currency and on an adjusted basis^4,5 to increase by 7% to 9% at constant currency.

The targets exclude the effect from the planned acquisition of NxStage Medical and the gain (loss) related to divestitures of Care Coordination activities.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the second quarter today at 3:30 p.m. CEDT / 9:30 a.m. EDT. Details will be available in the Investors/Events section. A replay will be available shortly after the call.

https://bit.ly/2LGSJ99

Sanofi Q2 2018 Performance Positions for New Growth Phase

	Q2 2018	Change	Change  at CER	H1 2018	Change	Change  at CER
IFRS net sales reported	€8,176m	-5.7%	+0.1%	€16,074m	-7.2%	-0.1%
IFRS net income reported	€762m	-26.2%	–	€1,778m	-73.6%(2)	–
IFRS EPS reported	€0.61	-25.6%	–	€1.42	-73,4%(2)	–
Business net income(1)	€1,558m	-7.9%	+0.4%	€3,156m	-9.4%	+0.4%
Business EPS(1)	€1.25	-6.7%	+1.5%	€2.53	-8.3%	+1.4%

Second-quarter 2018 sales stable(3) with strong contributions from Specialty Care and Emerging Markets Net sales were €8,176 million, down 5.7% on a reported basis, up 0.1%(3) at CER and down 2.5% at CER/CS (4). Sanofi Genzyme sales up 14.1% at CER/CS (4) (33.1% at CER) driven by Dupixent® and consolidation of Bioverativ. Vaccines sales down 15.7% reflecting high basis for comparison and expected Pentaxim® supply constraint in China. CHC sales increased 4.1% supported by growth in Europe and Emerging Markets(5). DCV(6) GBU sales down 15.6%; global Diabetes franchise sales declined 11.9%, confirming expected trend for year. Emerging Markets sales(5) increased 5.2% with double-digit growth in China. 2018 business EPS guidance range slightly narrowed Second-quarter 2018 business EPS(1) up 1.5% at CER to €1.25. Second-quarter 2018 IFRS EPS was €0.61 (-25.6%). Business EPS(1) in 2018 now expected to grow 3% to 5% at CER(7) barring unforeseen major adverse events. Currency impact on 2018 business EPS is estimated to be around -6% applying the average July exchange rates. Key achievements in sustaining innovation in R&D Sanofi completed the acquisition of Ablynx in May, internalizing the innovative Nanobody® platform. Positive CHMP recommendation for CabliviTM for aTTP(8). Phase 1/2a data on BIVV001, an extended factor VIII therapy, demonstrated half-life of 37 hours. A phase 2/3 study is being initiated on venglustat, an oral glucosylceramide synthase (GCS) inhibitor, in ADPKD(9). Positive phase 3 trial evaluating Dupixent® to treat moderate-to-severe atopic dermatitis in adolescents. Priority review granted in the U.S. to cemiplimab for the treatment of CSCC(10). ZynquistaTM (sotagliflozin) accepted for review by the FDA in type 1 diabetes. Praluent® ODYSSEY OUTCOMES results submitted to the FDA and EMA in Q2.

https://bit.ly/2vl3mDr

Otsuka, Lundbeck schizophrenia med approved by European Commission

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announce that the European Commission has approved Rxulti® (brexpiprazole) for the treatment of schizophrenia in adults. The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on May 31, 2018.

Lundbeck and Otsuka will now work with local pricing and reimbursement bodies in countries throughout Europe to help ensure that eligible patients are able to access Rxulti®. The medicine is expected to be made available in the first EU markets during first half of 2019.

Brexpiprazole is a once-daily, second-generation (atypical) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity for these receptors as well as for noradrenaline alpha1B/2C receptors. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.

https://bit.ly/2v0oBeo

Japan scientists to use ‘reprogrammed’ stem cells to fight Parkinson’s

Japanese scientists said on Monday they will start clinical trials next month on a treatment for Parkinson’s disease, transplanting “reprogrammed” stem cells into brains, seeking a breakthrough in treating the neurodegenerative disorder.

Parkinson’s is caused by a lack of dopamine made by brain cells and researchers have long hoped to use stem cells to restore normal production of the neurotransmitter chemical.

The clinical trials come after researchers at Japan’s Kyoto University successfully used human induced pluripotent stem cells (iPS) to restore functioning brain cells in monkeys last year.

So-called iPS cells are made by removing mature cells from an individual – often from the skin or blood – and reprogramming them to behave like embryonic stem cells. They can then be coaxed into dopamine-producing brain cells.

“This will be the world’s first clinical trial using iPS cells on Parkinson’s disease,” Jun Takahashi, professor at Kyoto University’s Centre for iPS Cell Research and Application, told a news conference.

The center is headed by Shinya Yamanaka, who in 2012 shared a Nobel Prize for medicine with a British scientist, John Gurdon, for the discovery that adult cells can be transformed back into embryo-like cells.

“We intend to carry on conducting our research carefully, yet expeditiously, in coordination with Kyoto University Hospital, so that new treatment using iPS cells will be brought to patients as soon as possible,” Yamanaka said in a statement.

The fact that the clinical trial uses iPS cells rather than human embryonic cells means the treatment would be acceptable in countries such as Ireland and much of Latin America, where embryonic cells are banned.

Sumitomo Dainippon Pharma Co Ltd has said it aims to manufacture and start selling cellular medicine based on the data from the clinical trials by the year ending March 2023.

The company said, however, the target is solely its own and not a shared goal with Kyoto University.

https://reut.rs/2NYgdTT

Dimon says Trump’s tax cut and deregulation have ‘accelerated growth’

• “We needed competitive taxes. The way the American public should be thinking of it is: For 20 years, we’ve been increasingly uncompetitive, driving capital and brains overseas,” says Jamie Dimon.
• Dimon also says some of the regulatory rollbacks pushed by Trump are helping small businesses.
• The J.P. Morgan Chase CEO is worried about President Donald Trump’s trade policies, however, noting they could “offset some of the benefits” of the tax overhaul and other measures.”

J.P. Morgan Chase CEO Jamie Dimon said Monday that President Donald Trump‘s tax cuts, along with some of his other efforts, have helped out the U.S. economy.

“Presidents get a lot of credit [and] a lot of blame for things they didn’t do, but the president has done things which accelerated growth,” Dimon told CNBC’s Wilfred Frost on “Closing Bell.” “We needed competitive taxes. The way the American public should be thinking of it is: For 20 years, we’ve been increasingly uncompetitive, driving capital and brains overseas.”

Dimon also said some of the regulatory rollbacks pushed by Trump are helping small businesses. “We’ve had less small business formation in America than in any other recovery,” he said. “This has accelerated the growth. It’s been 20 percent over 10 years; it should’ve been 40. The reason it wasn’t 40 is because of a lot of things that we did hurt ourselves.”

Dimon’s comments come after the Commerce Department said Friday the U.S. economy grew by 4.1 percent in the second quarter. That marked the highest growth rate since the third quarter of 2014, when the economy expanded by 4.9 percent.

Late last year, Trump signed a bill that lowered the federal corporate tax rate to 21 percent from 35 percent. Trump also eased or rolled back last year several pieces of regulation he felt were hurting U.S. businesses.

But Dimon said he is concerned that Trump’s trade policies could be a headwind to the U.S. economic expansion, noting: “I think it could offset some of the benefits” of the tax overhaul and other measures.

The Trump administration has taken an increasingly protectionist stance on trade recently. Earlier this month, the U.S. slapped tariffs on $34 billion of Chinese goods. The U.S. has also implemented tariffs on steel and aluminum imports from Mexico, Canada and the European Union. They have retaliated against those levies with tariffs of their own.

https://cnb.cx/2Kc7knd