Akebia: Positive CHMP Opinion in Europe for Vafseo™ (vadadustat) for Kidney Disease

  Akebia Therapeutics®, Inc. (NASDAQ: AKBA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo™ (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. The EC will review the CHMP recommendation and deliver a final decision in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

https://finance.yahoo.com/news/akebia-receives-positive-chmp-opinion-210500420.html

GE HealthCare, Sinopharm Unit Forming Joint Venture

 GE HealthCare Technologies Inc. on Friday said it agreed to form a long-term joint venture with a unit of China National Pharmaceutical Group Co., the state-owned group known as Sinopharm, to develop, manufacture and commercialize medical equipment to address the growing needs of China's healthcare market.

Chicago-based GE HealthCare said the venture initially plans to provide non-premium CT and general imaging ultrasound solutions for primary care and rural health, adding that the scope may be expanded as the venture develops.

GE HealthCare, which completed its separation from former parent General Electric Co. in January, already has a joint-venture relationship with Sinopharm through GE Hangwei Medical Systems, a medical equipment maker formed by General Electric and Sinopharm in 1991.

https://www.morningstar.com/news/dow-jones/202302243485/ge-healthcare-sinopharm-unit-forming-joint-venture

Biotechs plead for help and funds to find long COVID treatments

 Behind the unrelenting challenges of long COVID, which leaves many of the disease’s sufferers with exhaustion, sleep problems and brain fog, is just a handful of biotechs trying to drum up interest—and funds—to find a treatment.

“We know you're suffering and we are working as hard as we can to get this study up and running,” said Margaret Koziel, M.D, Chief Medical Officer at Axcella Therapeutics. “It's not been easy.”

That was the takeaway from an hours-long seminar on long COVID hosted Tuesday by the Biotechnology Innovation Organization (BIO), a lobbying and advocacy organization for the biopharma industry. The roundtable left few stones unturned, convening epidemiologists, patient advocates, federal health officials and drug manufacturers.

Underscoring the difficulty in treating long COVID is uncertainty in how many patients even have the disease. A November 2021 modeling estimate from the CDC put the figure between 3-5 million adults. But the agency’s more recent household pulse survey estimated that 15% of all adults have experienced long COVID.

Koziel’s candid statement is an understatement. Axcella laid off 85% of its staff at the end of 2022 to focus resources on long COVID. The drug now sewn to the hip of the company is AXA1125, which failed its latest phase 2 trial assessing the phosphocreatine recovery rate (PCr) following moderate exercise in treated patients compared to placebo. But the company found an encouraging enough signal in improving fatigue that it’s persevering. 

Now, Axcella has a phase 2/3 trial that has been green-lit in the U.K. and U.S., but the biotech needs more money. 

“We are presently looking for funding to start the study and complete the study,” said Koziel. 

The message was echoed by AIM Immunotech CEO Thomas Equels, whose company is trialing one of its top assets, Ampligen, in long COVID. Ampligen has already been tested in patients with chronic fatigue, with a confirmatory phase 3 trial slated to launch soon. The drug is also being developed to treat cancer. 

“We ask that if you're in industry or in government and you can support these clinical efforts, we beg you to help us move forward as rapidly as possible,” he said. 

Many large pharmas, on the other hand, have hauled in billions thanks to COVID vaccines and treatments, and yet few have offered up ideas to tackle long COVID. One major outlier is Pfizer, which is trying out its approved COVID treatment Paxlovid as a long COVID therapy, with two individual trials underway in conjunction with Stanford and Yale. The more recent Yale study was just cleared for enrollment, which a Pfizer spokesperson says will begin, “in the near term.”

Japanese Big Pharma Shionogi is similarly testing its COVID treatment, ensitrelvir, as a long COVID remedy. Exploratory data from the company’s phase 3 trial presented Tuesday found that 125 mg of ensitrelvir reduced the risk of long COVID by 45% compared to placebo.

The lack of funding noted by both Equels and Koziel is the byproduct of two separate but related trends: the first is a tightening private biotech market that’s been less willing to bet on risky projects. With so much heterogeneity among patients and few clear-cut biomarkers, trying to treat long COVID is, in fact, one of the riskier bets. 

The second issue is that federal attention on COVID-19 is winding down. The national public health emergency is set to end in May and while that won’t explicitly impact the FDA’s ability to issue emergency use authorizations, the agency has been more restrained in recent months. It’s become an often-used trope, but industry representatives at the Tuesday discussion underscored the need for the federal government to be as committed to treating long COVID as they were an acute infection. 

“There's a lot of wonderful individual efforts and we've heard about some today but not the really coordinated effort that I think we need to see,” said Christopher Austin, M.D., a CEO partner at Flagship Pioneering who joined the venture capital firm in 2021 after nine and a half years at the National Institutes of Health, including as director of the National Center for Advancing Translational Sciences. 

Still, the federal government is attempting to take the baton from patients who have become a leading force in the effort to galvanize research and resources. Recruitment is ongoing in large-scale observational studies of long COVID patients organized by the NIH, dubbed the RECOVER Initiative, with more than 15,000 adults, pregnant people and children enrolled so far. The goal is to deepen the understanding of long COVID’s biology, hopefully opening new doors for drug developers to find new treatments. 

The RECOVER Initiative is a bright spot for patients who feel like they’re being ignored and left behind as pandemic policies wane. Julie Gerberding, M.D., a former Merck executive and current CEO of the Foundation for the National Institutes of Health, said it's imperative that the collective focus of the medical and science communities does not wane. 

“I think we're all anxious that we've been too quick to try and put COVID in the rearview mirror, and we have to take care that long COVID doesn't end up in that place,” she said. 

https://www.fiercebiotech.com/biotech/its-not-been-easy-biotechs-stress-need-additional-funds-efforts-treat-long-covid-persist

Apple's long-desired glucose tracking is reportedly at proof-of-concept stage

 For much of the last decade, rumors swirling around Silicon Valley have suggested that Apple is aiming to one day bring completely noninvasive glucose tracking to its eponymous smartwatch.

And that day may be closer than ever, according to the latest of those accounts. Bloomberg reported Wednesday that the tech giant has reached the proof-of-concept stage for sensor technology that could ultimately allow Apple Watch wearers with diabetes to monitor their blood sugar levels around the clock without requiring any skin-pricking for calibration or analysis.

Bloomberg’s report cited a handful of unnamed sources familiar with the highly secretive project—known as E5 within the company. After more than a decade’s worth of work, the sources said E5 has recently hit “major milestones” that have made Apple optimistic about the technology’s commercial feasibility.

Apple declined to comment on Bloomberg’s report, nor did the company immediately respond to Fierce Medtech’s request for comment.

The E5 initiative reportedly dates back to 2010, when then-CEO Steve Jobs led the quiet acquisition of RareLight, a startup developing a new method for noninvasive glucose monitoring. In the years since, Apple became one of two primary customers of Rockley Photonics, the maker of biosensor technology that includes noninvasive blood sugar tracking—a development that further fed the rumors of Apple’s eventual entry into the diabetes management market.

The Rockley partnership has since ended, per Bloomberg—and Rockley has since filed for bankruptcy—with Apple shifting its chip-making needs to Taiwan Semiconductor Manufacturing Co.

Though it reportedly previously operated under the guise of a health tech startup that was seemingly completely separate from Apple and dubbed Avolonte Health, the E5 project is now housed within Apple’s Exploratory Design Group, or XDG, which serves as an incubator for a handful of so-called moonshot initiatives.

Apple’s approach is said to combine silicon photonics and optical absorption spectroscopy: It beams specific wavelengths of light into the interstitial fluid below the skin, and all light not absorbed by glucose bounces back to the sensor. From there, an algorithm calculates the concentration of glucose in the blood.

E5 has already cost the company hundreds of millions of dollars and is being worked on by hundreds of engineers, the sources told Bloomberg. If the noninvasive technology is ultimately cleared by the FDA for addition to the Apple Watch, it would be the third such nod for the wearable, joining its built-in ECG and the “AFib History” feature—a sharp reversal of CEO Tim Cook’s once-professed belief that the Apple Watch would never become an FDA-regulated device.

For now, though the approach has reportedly cleared preliminary trials comparing its performance to glucose trackers that require blood samples, the hardware is currently too big to be embedded into an Apple Watch. Once sufficiently shrunk down, however—a process that will likely take several more years—it could potentially be used not only to monitor diagnosed cases of diabetes but also to help detect early signs of the condition.

While other continuous glucose monitors also measure blood sugar levels by analyzing the amount of glucose in the interstitial fluid, the least invasive of those currently cleared by the FDA still require a small needle on the back of the sensor to pierce the skin and reach the fluid.

As Bloomberg noted, Apple’s reported success in the noninvasive arena seemed to strike a bit of a blow to some makers of those minimally invasive sensors. Immediately after the news broke on Wednesday, both Dexcom and Abbott’s stock prices slipped downwards: A day later, they’re sitting about 3.3% and 1.5% lower than before, respectively.

Apple has plenty more competition in the creation of a noninvasive approach to diabetes monitoring. Know Labs, for one, is developing a handheld device and wristband, both of which measure blood sugar by emitting radio waves through the skin to measure specific molecular signatures associated with glucose in the blood. Hagar’s GWave technology, meanwhile, operates through a similar mechanism, while GraphWear’s approach relies on nanotechnology.

https://www.fiercebiotech.com/medtech/apples-long-desired-glucose-tracking-reportedly-proof-concept-stage-bloomberg

Limiting salt could be deadly for heart failure patients: study

 People suffering from heart failure — a condition that affects 6 million American adults — who restrict their sodium intake may be increasing their risk of death, according to a new study presented Thursday.

Consuming too much salt has been linked to high blood pressure, heart disease and stroke, leading the Food and Drug Administration to advise Americans to eat no more than 2.3 grams of sodium per day. A US adult typically consumes 3.4 grams daily.

Researchers at the Creighton University School of Medicine in Omaha, Nebraska, have found that too little dietary sodium can actually put heart failure sufferers at greater risk — great news for those patients who want to salt up their food.

“Our findings showed that restricting dietary sodium to less than the usual recommendation was counterproductive in the management of heart failure,” Dr. Anirudh Palicherla, the study’s lead author and an internal medicine resident at the university, said in a statement.

While the FDA promotes dietary salt limits, Nebraska researchers are challenging the assumption that sodium restriction has positive benefits for heart failure patients.

Getty Images

Researchers analyzed nine randomized controlled trials that occurred between 2008 and 2022 — save for one that was published in 1991 — along with sodium intake data and information about patient deaths and hospitalizations.

In total, nearly 3,500 heart failure patients were included in the study, which was presented at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology.

The scientists determined that patients whose sodium intake fell below 2.5 grams per day were 80% more likely to die than those who consumed more, leading researchers to believe over-restricting has no benefits for these patients.

But researchers caution the study’s findings don’t warrant a salt free-for-all.

“Limiting sodium is still the way to go to help manage heart failure, but the amount of restriction has been up for debate,” Palicherla added. “This study shows that the focus should be on establishing a safe level of sodium consumption instead of overly restricting sodium.”

Their conclusions do, however, support previous claims that salt is not the enemy.

Dr. James DiNicolantonio, a cardiovascular researcher and author of “The Salt Fix,” previously told The Post that adults could actually consume 6 grams of salt a day without adverse health effects.

“We’re starting to understand that we probably had it wrong about salt 40 years ago,” he said in 2017, arguing that, actually, salt is the “gateway to eating healthy.”

A 2016 study drew similar conclusions. NYC researchers said they found no definitive proof that cutting salt intake reduces the risk of heart attacks or strokes — that is, for people in perfect health. But the NYC Health Department begged to differ, arguing that salt limitations and advisories have conclusive evidence to back them up.

In 2021, the FDA called on the food industry to reduce the amount of sodium in their products, hoping it would slash the number of heart-related fatalities. As it stands, heart disease is the leading cause of death in the US, with 695,547 lives claimed in 2021 alone, according to the Centers for Disease Control and Prevention.

Experts recommend limiting sodium intake by eating fresh fruits and vegetables and avoiding processed, boxed and canned foods.

https://nypost.com/2023/02/23/limiting-salt-could-be-deadly-for-heart-failure-patients-study/

China calls for peace talks, cease-fire between Russia and Ukraine

 On the eve of the one-year anniversary of Russia’s invasion of Ukraine, China has called for a cease-fire between the two sides and for peace talks to commence as part of a 12-point plan to end the war.

China’s Foreign Ministry revealed the plan on Friday, Beijing time, and also called for the end of Western sanctions on Russia, measures to ensure nuclear facilities, humanitarian corridors for civilians to flee the conflict and a process to ensure the continuation of grain exports.

“All parties should support Russia and Ukraine in working in the same direction and resuming direct dialogue as quickly as possible,” the paper released on China’s Foreign Ministry’s website stated. 

In the proposal, China indicated its opposition to the use of nuclear weapons in the conflict, as well as the threat of deploying them.

“Nuclear weapons must not be used and nuclear wars must not be fought. The threat or use of nuclear weapons should be opposed,” the paper said.

China also urged for civilians to be protected and for international law to be followed.

Russian Foreign Minister Sergey Lavrov, right, and the Chinese Communist Party’s foreign policy chief Wang Yi enter a hall for their talks in Moscow, Russia.

AP

“Parties to the conflict should strictly abide by international humanitarian law, avoid attacking civilians or civilian facilities,” it said.

According to the United Nations human rights office, at least 8,000 non-combatants have been confirmed killed in the war in Ukraine and more than 13,000 have been injured. 

Russia has also launched attacks against more than 250 Ukrainian hospitals since its Feb. 24, 2022, invasion, leaving nearly one in 10 Ukrainian hospitals damaged, according to a recent analysis by five different non-governmental organizations.

A bed is pictured in a house destroyed during the months of Russian occupation in the village of Posad-Pokrovske.

REUTERS

Despite the peace proposal, US officials have not ruled out that China could be preparing to provide lethal military aid to Russia.

Earlier this month, US Deputy Secretary of State Wendy Sherman said at an event at the Brookings Institution in Washington, DC, that the US has “growing concern” about the Chinese-Russian partnership. 

“My assessment is the PRC [People’s Republic of China] is trying to both increase its standing in the international community by saying that it’s willing to mediate and help bring this horrifying invasion to an end. And at the same time, they are committed to their no limits partnership with Russia,” Sherman said.

“And we have, certainly, concern and growing concern about that partnership and the PRC’s support for this invasion,” she added. 

US officials have not ruled out that China could be preparing to provide lethal military aid to Russia.

AP

Chinese state-controlled firms have sold non-lethal drones and other equipment to both Russia and Ukraine since the start of the conflict.

China abstained Thursday when the United Nations General Assembly voted on a nonbinding resolution calling for Russia to end hostilities in Ukraine and withdraw from the former Soviet state. 

After releasing the peace plan, the Chinese Ministry of Foreign Affairs vowed Friday that the PRC will “continue to play a constructive role” in the resumption of peace talks, but it did not elaborate as to how. 

Top Chinese diplomat Wang Yi met on Wednesday with Russian President Vladimir Putin and Russian Foreign Minister Sergey Lavrov in Moscow.

Russia United Nations Ambassador Vassily Nebenzia, center right, listens before the U.N. General Assembly vote in favor of a U.N. resolution upholding Ukraine’s territorial integrity and calling for a cessation of hostilities after Russia’s invasion.

AP

The Kremlin said Beijing had presented its views on approaches to a “political settlement” of the conflict.

Ukrainian President Volodymyr Zelensky said Thursday he had not seen the Chinese peace plan and wanted to meet with Beijing and discuss any proposal before assessing it.

“I think it is a very good fact in general that China started talking about Ukraine and sent some signals,” Zelensky said.

“We’ll draw some conclusions after we see the specifics of what they offer … We would like to have a meeting with China.”

The entire 12 points of China’s abstract peace proposal are listed below: 

1. Respecting the sovereignty of all countries
2. Abandoning the Cold War mentality.
3. Ceasing hostilities. 
4. Resuming peace talks. 
5. Resolving the humanitarian crisis. 
6. Protecting civilians and prisoners of war (POWs).
7. Keeping nuclear power plants safe.
8. Reducing strategic risks. 
9. Facilitating grain exports.
10. Stopping unilateral sanctions.
11. Keeping industrial and supply chains stable.
12. Promoting post-conflict reconstruction. 

Chinese President Xi Jinping is planning to visit Moscow for a summit with Russian President Vladimir Putin in the coming months, according to a Wall Street Journal report. 

The meeting is expected to be part of China’s push to end the war in Ukraine, according to the report. 

https://nypost.com/2023/02/23/china-calls-for-peace-talks-cease-fire-between-russia-and-ukraine/