FDA OKs Lilly/Boehringer Jardiance for certain heart failure type

 Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.

Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.

Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

"Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical," said Javed Butler, M.D., Chairman, Department of Medicine, University of Mississippi. "Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction."

https://www.shelbynews.com/news/state/us-fda-approves-jardiance-empagliflozin-to-treat-adults-living-with-heart-failure-with-reduced-ejection/article_f33111ae-fc87-5830-acb1-f7a33ca82e44.html

BrainsWay Shares Rise 25% After FDA Clearance for Depression Treatment

 BrainsWay Ltd. shares rose 25% to $9.52 after the company said it received 510(k) clearance from the U.S. Food and Drug Administration, allowing it to market its Deep Transcranial Magnetic Stimulation System for the reduction of comorbid anxiety symptoms in adult patients with depression.

The company said data from 573 patients who had undergone Deep TMS treatment in 11 studies, including both randomized controlled trials and open-label studies, was submitted by BrainsWay in support of its application to the FDA. The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder.

An analysis of the BrainsWay data found favorable outcomes with Deep TMS when compared to sham or medication as standard of care.

The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

https://www.marketscreener.com/quote/stock/BRAINSWAY-LTD-57476379/news/BrainsWay-Shares-Rise-25-After-FDA-Clearance-for-Depression-Treatment-36193636/

Marinus Pharmaceuticals Shares Down After Study Data

 Marinus Pharmaceuticals Inc. shares fell 7.5% to $11.14 after the pharmaceutical company reported data from a Phase 2 study.

The company Tuesday reported data from its Phase 2 trial evaluating adjunctive oral ganaxolone treatment in 23 patients with seizures associated with tuberous sclerosis complex.

The data showed a median 16.6% reduction in 28-day primary endpoint seizure frequency relative to the four-week baseline period, with 30.4% of patients achieving a 50% or more seizure reduction.

Truist Securities said interim data showing 47.6% median seizure reduction was highly encouraging, but "final Ph2 data showing 16.6% median seizure reduction...while within margin of error, may nonetheless be viewed as a bit disappointing."

Marinus said it also had meaningful 50% responder rates in subgroups of highly refractory seizure patients on concomitant medications cannabidiol or everolimus.

Truist in its analyst note said that despite a high bar, ganaxolone led to further seizure reductions on top of standard of care drugs cannabidiol and everolimus.

"Given the efficacy of the recently approve anti-epileptics cannabidiol and everolimus, we think further seizure reduction of GNX as add-on is highly impressive," Truist said in its note.

Due to drug-drug interaction of cannabidiol and everolimus "we think GNX is particularly well-poised to be the preferred add-on to EVE, which is widely used to treat several non-seizure manifestations of TSC," the analyst note said.

Marinus said it expects a Phase 3 trial of adjunctive ganaxolone in about 160 TSC patients to begin enrollment during the fourth quarter.

"We think GNX has clear efficacy signal in TSC. But the hurdle will be in proper pivotal trial design and execution," Truist said.

https://www.marketscreener.com/quote/stock/MARINUS-PHARMACEUTICALS-17053985/news/Marinus-Pharmaceuticals-Shares-Down-After-Study-Data-36194073/

U.S. plans to offer boosters to all Americans starting in late September

 Top U.S. health officials announced Wednesday that the country has developed a plan to start offering Covid-19 booster shots to all Americans beginning the third week of September, citing evidence that protection is waning not only against hospitalization and death, but also mild and moderate infections, as the highly contagious delta variant continues to spread.

"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," federal health officials said in a joint statement Wednesday.

The statement was signed by the heads of the Centers for Disease Control and Prevention, the National Institutes of Health and the Food and Drug Administration, among others.

The administration is preparing to begin administering the booster shots starting the week of September 20, assuming that the FDA and the CDC sign off on the safety and effectiveness of the doses by that point.

Individuals would be eligible for a third dose of either the Moderna or Pfizer-BioNTech shots eight months after their second dose.

The nation is already giving additional shots to people with compromised immune systems, who were unable to mount a robust response to the first round of vaccinations.

The rollout of boosters in the general population will likely mirror the original vaccine rollout, with healthcare workers, nursing home residents and people over age 65 first in line.

"We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that Covid-19 poses to them," the statement read.

The plan does not yet include those who received Johnson & Johnson's vaccine, the rollout of which started several months after the Pfizer and Moderna vaccines. Health officials said they anticipate boosters will be needed in that group as well, and expects more data on Johnson & Johnson effectiveness in the coming weeks.

The CDC is expected to unveil new data on the need for booster shots Wednesday afternoon, and President Joe Biden is scheduled to deliver remarks on the matter later in the day.

Any plan to administer booster shots in high-income countries such as the U.S. has been met with opposition by the World Health Organization. Earlier this month, the WHO's Director-General, Tedros Adhanom Ghebreyesus, said that more than 80 percent of the world's vaccine supply has gone to the richest countries, even though they account for less than half of the global population.

"We cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world's most vulnerable people remain unprotected," Tedros said.

Dr. Aaron Richterman, an infectious diseases expert at the University of Pennsylvania, agreed, saying the most important benefits of the Covid-19 vaccines are for people who haven't had a chance to get a single shot.

"When you're looking at low-income countries, that's 99 percent of people," Richterman said. "Literally, millions of lives are at stake."

https://www.nbcnews.com/health/health-news/u-s-announces-plan-offer-boosters-all-americans-starting-late-n1277059

NRx Pharma: Positive Safety Report for NIH Sponsored Study in Life-Threatening COVID-19

 After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients

- ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19

- ACTIV-3 Critical Care is Evaluating ZYESAMI™ and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo

https://finance.yahoo.com/news/nrx-pharmaceuticals-announces-positive-safety-155300349.html

COVID delays Apple moving production away from China

 Apple, Google, and others are having to delay or reduce plans to move manufacturing away from China, as the impact of the coronavirus makes governments increase border controls.

Partly because of US/China trade tensions, and partly to avoid over-reliance on one source, Apple and other firms have been steadily moving away from China. Now, however, new COVID outbreaks have affected international trade as governments attempt to contain new variants of the virus.

According to Nikkei Asia, tighter border controls and intermittent travel restrictions are affecting the plans of Apple, Google, Amazon, and component suppliers.

Reportedly, Apple's plans to mass produce AirPods and AirPods Pro in Vietnam have been been particularly affected. For now, they will continue to be produced in China, though unnamed sources say Apple still aims to move 20% of AirPods production to Vietnam at some point.

"[Vietnam's] engineering workforce is still far from adequate," a supply chain executive familiar with Apple and Google's plans, told Nikkei Asia. "With all the travel restrictions, it's only feasible to make products in Vietnam that are already in mass production elsewhere, rather than starting production of upcoming products from scratch in the country."

"[Border control] has been tightened in the past few months," a separate Amazon supplier manager said. "We could not easily dispatch our Chinese engineers to support our production projects for Amazon in northern Vietnam, so the company has been bringing in fully vaccinated Taiwanese engineers from China."

Reportedly, the Vietnamese government has also ordered factories to halt production, unless they can accommodate workers with sleeping facilities, or travel arrangements. Nikkei Asia says that Apple suppliers including Foxconn and Luxshare briefly suspended production over COVID measures.

The publication's same sources say that Apple has also put on hold its intention to bring some proportion of MacBook Pro and iPad production to Vietnam.

https://appleinsider.com/articles/21/08/18/covid-delays-apple-moving-production-away-from-china

Some J&J vaccine recipients feel unprotected from delta, want mRNA shots

 Kevin Rosengren stared at the piece of paper in disbelief. No antibodies.

The 46-year-old resident of Richmond, Virginia, received theone-dose Johnson & Johnson vaccine in March. He was confident in the vaccine’s effectiveness and finally felt free to leave his house, travel and meet with friends. 

But lately, news of the highly contagious delta variant driving a surge of COVID-19 cases worries him. He doesn’t want to bring the virus home to his unvaccinated 11-year-old son.

Rosengren confided in his pharmacist, who offered an antibody test to dispel his concerns. Unfortunately, the results only added to them.  

“I had this coat of armor on before, and now I feel completely naked in the world of COVID,” he said. 

The Food and Drug Administration does not recommend antibody testing, because it's not clear what level of antibodies is protective enough and because different tests yield different results. 

Rosengren knows the test may have been inaccurate, and he still has confidence in all the COVID-19 vaccines authorized by the FDA. But he can’t help wondering if he’s one of the unlucky few whose body did not react properly to the J&J vaccine.

“You always have this little thing at the back of your mind, no matter how much data you read, like, ‘I’ve had one shot, and other people have two shots,’” he said. “I don’t want to be worried anymore. I’m tired of getting worried.”

Rosengren is part of a growing group of healthy J&J vaccine recipients contemplating whether they should get a “booster” dose from one of the mRNA vaccines from Pfizer-BioNTech or Moderna, hoping to improve their chances against the delta variant.

As of Friday, the Centers for Disease Control and Prevention reported more than 13.7 million people had gotten the J&J jab,and about 1% of them got additional shots. Health experts said real-world evidence shows it protects against the worst outcomes of COVID-19, and it’s too early to recommend additional doses to healthy recipients.

J&J's pivotal large-scale trial showed it was effective against COVID-19, preventing more than 70% of symptomatic infections and about 86% of serious ones. New data the company presented July 22 to a federal advisory committee showed the protection lasts against all variants circulating for at least eight months.

As long as the J&J vaccine protects against the severest forms of COVID-19, healthy people don’t need a booster shot, Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, said Tuesday in a public conversation with Brown University School of Public Health.

“We will cross the line where we know we need a booster dose when people who are fully vaccinated nonetheless are hospitalized with (J&J) or dying of COVID,” he said. “We’re not there, yet.”  

Although J&J studies show its vaccine offers protection against most of the known variants, a study posted online July 19 but not yet peer-reviewed suggested it was less effective against the delta variant. Researchers from New York University found that blood samples from people who received the J&J vaccine were less able to neutralize the delta variant than blood from people who received the Pfizer-BioNTech or Moderna shots.

This form of lab testing offers hints of protection but is not as reliable as showing whether the vaccine works in people, experts said.

Angela Rasmussen, a virologist at Georgetown University, told CNBC she received a booster shot of Pfizer and BioNTech’s COVID-19 vaccine in late June, about two months after she got J&J’s single dose. 

She told the news outlet she was concerned about her level of protection against the delta variant. Rasmussen did not reply to USA TODAY's request for comment. 

The San Francisco Department of Public Health began allowing J&J vaccine recipients to get a “supplemental dose” of one of the mRNA vaccines. To qualify, residents must have had their single dose shot in San Francisco and attest that a health care provider discussed the risks and benefits with them.

The public health department emphasizes “supplemental vaccines are not required or recommended,” and those who have gotten a J&J vaccine are considered fully vaccinated. 

Mixing and matching mRNA vaccines with other vaccine technology is not a part of the FDA’s emergency use authorization, but there is some preliminary data that supports it.

A study in June led by researchers at the University of Oxford suggests mixing vaccines may protect better than the two-dose mRNA vaccine regimen. The Lancet preprint study not yet peer-reviewed, found people who received both the AstraZeneca and Pfizer-BioNTech vaccinesmay have had a better immune response than those vaccinated with just Pfizer.

In May, researchers at the Carlos III Health Institute in Madrid announced results from a study that found a strong immune response in people who received the same AstraZeneca-Pfizer combination. The AstraZeneca vaccine is a viral vector vaccine, the same technology used by the J&J vaccine. 

Health experts are waiting for more concrete evidence.

“More is not always better,” said Tammy Lundstrom, infectious diseases specialist and chief medical officer at Trinity Health in Livonia, Michigan. “It’s prudent to wait for the science to dictate who needs a booster, what’s the optimal spacing (between shots) and whether mixing and matching is safe.”

While they wait for the data, she said, concerned J&J vaccine recipients should wear masks and avoid crowded areas as an extra layer of protection against the virus. 

Instead of debating “boosters” for healthy vaccinated people, Offit said, the conversation should be redirected to vaccinating those who still haven’t gotten their shot, as the delta variant thrives on the unvaccinated.  

“This discussion of boosters is just off point,” he said. “The problem in this country is not boosting people who have already been vaccinated, the problem in this country is vaccinating people who haven’t been vaccinated.

“That’s what we need to focus our efforts – all our efforts – on.”  

https://www.usatoday.com/story/news/health/2021/08/15/covid-j-j-vaccine-receivers-want-pfizer-moderna-booster-safe/8109007002/