Promising New Alzheimer’s Drug Fast-Tracked In China!
In a surprise to many researchers around the world, Chinese authorities recently approved a novel drug claimed to improve cognitive function in patients with Alzheimer’s disease.
The drug, derived from a marine algae, is the first new Alzheimer’s drug to reach the market anywhere in the world in almost 20 years, and is suggested to reduce neuroinflammation by modulating a person’s gut microbiome (the microbiome again!).
GV-971, or sodium oligomannate, is derived from a common form of seaweed called brown algae. For several years the compound has been under investigation in China as a treatment to slow, or even reverse, cognitive decline associated with mild to moderate cases of Alzheimer’s disease.
The latest announcement from China’s National Medical Products Administration (NMPA) has granted the drug “conditional approval”, meaning it is to be fast-tracked to market based on positive early Phase 3 trial results. The “conditional approval” requires ongoing studies to verify efficacy and safety, however, it can now move to open market sales in China within the next month or two.
“I have been doing research on Alzheimer’s disease for 50 years, participated in multiple global multi-center studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer’s disease,” says Zhang Zhenxin, MD, a principal investigator on the latest trial. “The result of the 9-month trial of Oligomannate is exciting. We finally see hope and dawn. I am sincerely happy for the patients and their families.”
And..Alzheimer’s Drug Unexpectedly Resurrected In USA
In a stunningly unusual turn of events a new Alzheimer’s drug, previously declared a failure back in March, has been resurrected with the pharmaceutical company behind the treatment suggesting the earlier decision to discontinue the research was premature and based on incorrect data analysis.
Biogen’s decision to immediately discontinue human trials for a promising Alzheimer’s drug called aducanumab came on the heels of several other big research failures into drugs designed to slow, or even reverse, neurodegeneration and cognitive decline. At the time the company suggested an independent data monitoring committee had evaluated early results from two large, global Phase 3 human trials and concluded they were failing to meet primary efficacy endpoints.
This new announcement from Biogen suggests that earlier data analysis, called a futility analysis, may have been premature and more recent study of larger datasets from one of the two Phase 3 trials has revealed significantly successful results. Biogen is claiming as the trials progressed, and concerns over side effects dissipated, more patients were exposed to higher doses of aducanumab.
The early independent analysis of the trial data apparently only evaluated data gathered up to December 2018, but the trials continued until March 2019. Examining those extra months of data revealed patients receiving longer exposure to higher doses displayed significantly slower rates of cognitive and functional decline compared to the control group.
This could be the second completely unexpected breakthrough in the long war against Alzheimer’s.
Will You Trust Facebook With Your Medical Data?
Facebook is rolling out its latest new idea across the United States – a preventative health tool, designed to remind users when their health check-ups are due and where to go to get them.
The recommendations delivered by the new tool are based on information provided by several independent organizations, including the Centers for Disease Control and Prevention (CDC).
The tool is accessible by searching for “Preventative Health” on the Facebook platform, and personalized health recommendations will be based on age and sex data supplied by the user. Based on guidelines supplied by organizations such as the American Cancer Society, the American Heart Association and the CDC, the tool will offer users information on what health check-ups they should undertake. These tests could include colorectal cancer screening for subjects in their 50s or regular blood pressure check-ups for older users.
“Heart disease is the number one killer of men and women around the world and in many cases it is 100 percent preventable,” says Richard Kovacs, president of the American College of Cardiology. “By incorporating prevention reminders into platforms people are accessing every day, we’re giving people the tools they need to be proactive about their heart health.”
World’s Biggest Battery Set To Grow By 50%
The biggest battery in the world is set to soon grow even bigger. The Hornsdale Power Reserve in South Australia, built by Tesla and managed by renewable energy company Neoen, will be expanded by an extra 50 percent early next year.
The Hornsdale facility was built in 2017 to help alleviate the energy woes of the state of South Australia, which had seen rolling blackouts the previous summer.
With a capacity of 129 MWh and an output of up to 100 MW, Hornsdale became the world’s largest lithium-ion storage battery, a title that it still holds two years later. And now, it looks set to strengthen its lead with a new expansion.
Tesla, Neoen and the South Australian government are looking to boost the battery by an extra 50 percent, adding 64.5 MWh of capacity and 50 MW of output. The upgrade will also add Tesla’s Virtual Machine Mode, which will allow the system to help maintain the power grid’s inertia, which provides stability in the face of fluctuating supply and demand.
Offshore Wind Energy Can Power Entire World
Offshore wind power has the capacity to meet all of the world’s electricity demand, and is set to be a “game-changer” for energy systems, according to the International Energy Agency.
The Paris-based energy watchdog said that the falling costs of offshore wind would make it competitive with fossil energy within the next decade, forecasting that the global average cost of power generated by offshore wind would drop a further 40 per cent by 2030.
“It has the potential to be a major game-changer,” said Fatih Birol, executive director of the IEA. He compared it to the two significant power trends of the past decade: the advent of fracking in shale formations — which enabled cheap natural gas, and the explosive growth in solar. “Looking at the future of offshore wind . . . it has the potential to join the ranks of shale [gas] and solar photovoltaics in terms of steep cost reductions,” said Mr Birol.
First “Natural” Designer Babies Will Be Born In 2020
Sometime next year, if all goes to plan, a gay male couple in California will have a child. The child in question will have been conceived by in vitro fertilisation. In this case a group of eggs from a female donor are now being fertilised by sperm from both fathers (half from one, half from the other). Of the resulting embryos, the couple will choose one to be implanted in a surrogate mother. An uplifting tale of the times, then, but hardly a newsworthy event. Except that it is. Where the story becomes newsworthy is around the word “choose”.
For the parents, in conjunction with a firm called Genomic Prediction, will pick the lucky embryo based on a genetically estimated risk of disease.
Such pre-implantation testing is already used in some places, in cases where there is a chance of parents passing on a condition, such as Tay-Sachs disease, that is caused by a single faulty gene.
Genomic Prediction is, however, offering something more wide-ranging. It is screening embryos for almost 1m single-nucleotide polymorphisms (snps). These are places where individual genomes routinely differ from one another at the level of an individual genetic letter. Individual snp differences between people rarely have much effect. But add them up and they can raise or lower by quite a lot the likelihood of someone suffering a particular disease. Generate several embryos and snp-test them, then, and you can pick out those that you think will grow up to be the healthiest.
Magic Mushrooms Now “Breakthrough Therapy” For Depression
The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD).
Back in late 2018, the FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin, the key psychoactive compound in magic mushrooms, as a therapy for treatment-resistant depression. A large, multi-center Phase 2 trial spanning the US, UK and Europe is currently underway testing a variety of dosing strategies.
This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.
Last year’s Breakthrough Therapy designation was targeted at the drug’s efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD.
First Wearable Artificial Kidney Now In Trials
We are a step closer to having reliable, wearable artificial kidneys, after a prototype device that is worn like a small handbag was used successfully in patients for the first time.
While the technology still needs refining, it could eventually free people from being tied to large dialysis machines or hooked up to bags of fluid and tubing, says its developer Marjorie Foo at Singapore General Hospital. “For some patients, dialysis is controlling their life – this gives a bit more freedom.”
People whose kidneys are failing usually need a transplant, but may spend years on a waiting list. In the meantime, they have to undergo dialysis to remove toxins from their blood.
In a trial that finished last year, the device was used successfully for three days by 15 people. Blood tests suggested it worked as well as conventional dialysis and would only need to be used for two 7-hour sessions a day.
New “Janitor” Robot Goes Into Service
SoftBank has announced North American availability of its new Whiz robotic vacuum sweeper. Designed in partnership with Hong Kong-based ICE Robotics, Whiz is intended for use in large indoor settings such as airports, hotels and college campuses.
It utilizes the BrainOS commercial robot operating system to memorize up to 600 cleaning routes. Human staff members start by manually guiding the robot through each of those routes, after which it’s able to follow them autonomously.
A computer vision system allows Whiz to avoid obstacles and to clean right up along the walls – if it runs into any unsurmountable problems, it notifies staff via a pager system. Additionally, it’s possible to remotely check on the robot’s operational status in real time, via a cloud-based portal.