Kamila Valieva's entourage to be investigated by anti-doping group

 Scrutiny of those around Kamila Valieva has increased after the World Anti-Doping Agency said it will investigate the adults working with the teenager.

The 15-year-old Russian's failed drugs test has cast a dark cloud over the Beijing Winter Olympics, with her age prompting questions over how a child became embroiled in suspected doping.

The figure skater was training in Beijing on Sunday, hours before a hearing to determine her Olympic fate.

She came here tipped for women's gold.

The European champion, who failed a drugs test in December, will hear on Monday if she can compete in the individual women's event in Beijing on Tuesday and if she is being stripped of team gold.

A hearing is set for Sunday at 12:30 GMT and a Court of Arbitration for Sport (Cas) panel will then decide whether to suspend her.

The International Olympic Committee (IOC) had earlier called for global anti-doping body Wada to investigate her entourage.

Hours later, Wada said it would ask its independent intelligence and investigations department to look into the coaches, doctors and other adults surrounding her.

Kamila Valieva's training has been watched by soft toys as well as global media

Valieva has continued to train amid the uncertainty and media attention, sometimes looking tearful.

The soft toys at the rink are a reminder of her tender age and the reason why this case has been even more shocking than other failed drugs tests.

Olympic Games executive director Christophe Dubi said it was important to remember the "human side of this story... to think about a person of 15 in this situation".

"We need to treat this situation extremely carefully."

Who is in Valieva's entourage?

Among those who have been watching Valieva train are her three coaches (left to right) Daniil Gleikhengauz, Sergei Dudakov and Eteri Tutberidze

At times in practice Valieva has been embraced by one of her coaches Eteri Tutberidze, who is now under the spotlight as among those who could be considered part of the "entourage".

In a brief interview with Russian state television, Tutberidze said she was certain the teenager was "clean and innocent".

Also seen watching from the side of the rink in Beijing have been her other coaches Sergei Dudakov and Daniil Gleikhengauz, and also team doctor Filipp Shvetsky.

The coaches are all from the Sambo-70 club in Moscow, which has produced a series of successful young skaters in recent years.

They include Pyeongchang 2018 champion Alina Zagitova, who was 15 when she won gold and 2018 silver medallist Evgenia Medvedeva, who was 18. Meanwhile, Yulia Lipnitskaya, was 15 when she won team gold at Sochi 2014.

Russian skaters arrived in Beijing strongly fancied to sweep the podium in the women's event - with 17-year-olds Alexandra Trusova and Anna Shcherbakova having finished behind Valieva in a Russian 1-2-3 at the European championships last month.

The trio share the same coaches and all three regularly perform quadruple jumps - the most difficult in the sport and very rare in women's figure skating in general.

Neither Trusova nor Shcherbakova have had any issues with their tests.

Valieva's future in hands of three-person panel

The IOC says the Cas hearing will only be about the lifting of Valieva's provisional suspension, which was imposed by the Russian Anti-Doping Agency (Rusada).

The full case will be heard by Rusada because the drug test was at a national competition, but Wada can appeal against any decision.

Valieva returned a positive test for the banned substance trimetazidine at the Russian Figure Skating Championships on 25 December.

But it was only reported on 8 February, the day after she became the first female skater to land a quadruple jump at an Olympics to help the Russian Olympic Committee team win gold.

When the issue came to light, the medal ceremony was postponed at short notice.

The medals for the team event - in which the United States finished second, Japan third and Canada fourth - will not be awarded until after the outcome of the hearing.

Trimetazidine is used in the prevention of angina attacks but is on the banned list because it is classed as a cardiac metabolic modulator and has been proven to improve physical efficiency.

Valieva has been allowed to train after a successful challenge against her provisional suspension by Rusada.

But the IOC, Wada and the International Skating Union (ISU) have now appealed to Cas against Rusada's decision to allow her to continue.

The Cas panel will consist of president Fabio Iudica of Italy and arbitrators Jeffrey Benz, of the United States, and Slovenian Vesna Bergant Rakocevic.

https://www.bbc.com/sport/winter-olympics/60364731

Germans pin hopes on Novavax moving the needle among anti-vaxxers

 Benedikt Richter, a 40-year-old teacher in the southwest German city of Kaiserslautern, long held out against getting vaccinated against COVID-19. He felt uneasy about the novelty of the mRNA technology used in two of the most commonly administered shots.

It did not help that his sister-in-law was hospitalised with heart muscle inflammation a day after receiving her second shot, which doctors officially linked to her vaccine, Richter said. Regulators have acknowledged such conditions as a rare and mostly mild side-effect.

But when the European Union in December approved the use of the Novavax vaccine Nuxavoxid, which deploys a long-established protein-based technology, he became interested.

“I have done my research and I have a slightly better feeling about it,” said the father of two.

Data unearthed by Reuters suggests the new two-dose vaccine, recommended in Germany for basic immunisation for people over 18, is already going some way to convince more of the as-yet unvaccinated to get a shot.

Some federal states have opened waiting lists to receive Novavax shots. In Rhineland-Palatinate where Richter lives, for example, more than 14,300 people have put down their names. A private Berlin vaccination centre told Reuters they had around 3,000 people registered.

“The number is gigantic. We’re overwhelmed ourselves by how many people have signed up,” said Daniel Termann, a doctor at the Historic Factory vaccination centre in Berlin.

The recombinant protein technology behind the Novavax shot has been in use since the mid-1980s and is now a standard tool to fight hepatitis B, the human papillomavirus behind cervical cancer, and bacteria that cause meningitis.

A recent survey by researchers at the University of Erfurt with 1,000 participants found that even though unvaccinated Germans had more confidence in traditional vaccines than in mRNA vaccines, trust generally was still low. (Graphic: GRAPHIC-Vaccine confidence, https://graphics.reuters.com/HEALTH-CORONAVIRUS/byprjxdrope/chart.png)

Almost two thirds of the unvaccinated were completely against vaccination, the survey found, suggesting that only a small proportion would ever consider taking the Novavax shot.

“We are not convinced that it will be a game changer,” study co-author Lars Korn told Reuters.

Much is on the line. Germany has a lower inoculation rate than many other countries in western Europe at just 74.4% fully vaccinated.

But if Nuxavoxid were able to move the needle, that could prompt an easing of restrictions on public life that are dragging on the recovery of Europe’s largest economy.

A JAB FOR FREEDOM

The problem then would be more of how to ensure supply.

Germany is set to receive up to 34 million Nuvaxovid doses in 2022 and around 4 million doses should be delivered in the first quarter, a spokesperson for the health ministry said.

But there are around 20 million unvaccinated people in Germany. And a Reuters report showed on Tuesday that Novavax had delivered just a small fraction of the 2 billion COVID-19 shots it plans to send around the world in 2022 and had delayed first-quarter shipments in Europe and lower income countries such as the Philippines.

Health sector workers will be prioritised to receive the vaccine in the first quarter as a vaccine mandate for them will come into effect in mid-March, according to the federal health ministry.

That could prove frustrating for those who are nervous of mRNA vaccines but also fed up with restrictions on public life.

In many states in Germany, the unvaccinated are banned from non-essential shops and service providers like restaurants and barber shops.

In a group chat about Novavax on the Telegram messenger service, many of the more than 1,500 members toyed with getting the shot due to pandemic curbs.

Richter, who has had to take a daily COVID test to teach and learned how to cut his hair by himself, said his main motivation to get vaccinated was freedom.

He misses sauna visits, which get him through Germany’s dark winters, and would love to take his two children swimming again.

“I have two children and they are also restricted because of me,” he said. “I am not doing it out of conviction, but rather from external pressure.”

https://wtvbam.com/2022/02/13/germans-pin-hopes-on-novavax-moving-the-needle-among-anti-vaxxers/

Canada protesters, police deadlocked as tensions simmer at blocked U.S. border bridge

 A tense standoff between Canadian police and protesters opposing COVID-19 restrictions was set to continue on Sunday, as a court order and threats of arrest have failed to end a blockade of a key Canada-U.S. border crossing.

President Joe Biden has asked Prime Minister Justin Trudeau to use federal powers to the end blockade of the Ambassador Bridge, North America's busiest land border crossing. Since Monday, protesters in trucks, cars and vans have blocked traffic in both directions, choking the supply chain for Detroit's carmakers.

Despite a court order to end to the occupation and a state of emergency imposed by the province of Ontario, home to the city of Windsor, police have failed to disperse the crowd and resume cross-border traffic.

Police moved in early on Saturday, pushing protesters back from the foot of the bridge, but more people streamed into the area in the afternoon and the operation appeared to have stalled. Late on Saturday, Windsor Police arrested a 27-year old man for a criminal offence in relation to the demonstration.

"I am very hopeful still that police can ... try and get to these folks in a reasonable way and have them understand that it's time to move on," Windsor Mayor Drew Dilkens told CBC News. "We can no longer afford as a country to keep it closed."

By evening, the protest was still going on, and police had pushed the demonstration only 500 yards from the original rally point at the foot of the bridge. But they sealed off side streets to keep more cars from coming in as they worked to clear Huron Church Road and restore bridge traffic.

The rally was set to continue into the night, as the large crowd faced off peacefully with the police who seemed intent on avoiding violence. Demonstrators waved Canadian flags and bellowed shouts of “Freedom!”

There was no traffic moving from Detroit to Windsor on the bridge as of 6:14 p.m. EST, according to the website of Canada’s border agency. Those lanes have been closed since the protesters arrived Monday, as part of a larger opposition to vaccine mandates for truckers and Covid-19 restrictions generally.

“These are people who have been told by protest organizers that they’re violating no laws,” Michael Kempa, an associate professor of criminology at the University of Ottawa, told CBC News. “So the police have a tough challenge on their hands in that they’re constantly trying to demonstrate to people that their protest is, in fact, illegal. That’s why they’re moving so slowly. It’s just a constant communicative strategy.”

Ontario’s Superior Court granted an injunction Friday to end the blockade, hours after Ontario Premier Doug Ford called a state of emergency in Canada’s largest province and Prime Minister Justin Trudeau told protesters that it’s time to go home. A larger protest has been taking place for more than two weeks in Ottawa, where hundreds of semi trucks have blocked downtown streets, including the one in front of Canada’s parliament.

The Ambassador Bridge between Windsor and Detroit has been closed almost entirely since Monday night. The conduit carries about one-quarter of the commercial goods trade between the U.S. and Canada -- an estimated $13.5 million an hour.

It’s particularly vital to the auto sector, which relies on a supply chain that includes assembly plants and parts makers in Ontario and Quebec. Automakers including General Motors, Ford Motor Co., Stellantis and Toyota Motor Corp. have been forced to curb production this week for lack of parts. An association of auto parts manufacturers was among the parties that applied for the court injunction.

The demonstrations have had staying power in Canada in large part because police, wary of stoking violence, have hesitated to make arrests and clear the blockades.

Ontario’s premier Friday called the situation “a pivotal moment for our nation” and said the eyes of the world were watching how Canada and its leaders deal with public unrest over vaccine mandates and Covid-19 restrictions. His government enacted new powers to end the blockades, including the threat of fines of as much as C$100,000 ($78,500) and jail time.

Police passed out fliers Friday night at the bridge protest, warning of the penalties for not leaving. But many protesters said they had no intention of budging.

“This is about freedom. And this is about our rights being stolen from us,” said Ronald Lyons, who was there with his adult son. “I’m willing to starve for this country.”

Another protester who declined to give her full name said she was willing to be arrested rather than back down. The woman said she was a former health-care worker who lost her job because she refused to get vaccinated, and now works as a supermarket cashier for half the pay.

On Saturday morning, reports indicated that the blockade was ending and one protester told local radio station WWJ 950 that their mission had been accomplished. That didn't happen.

https://www.autonews.com/manufacturing/canada-protesters-police-deadlocked-tensions-simmer-blocked-us-border-bridge

Sanofi's Bioverativ deal begins to pay dividends with first new drug approval

 

• The Food and Drug Administration last week approved Sanofi's Enjaymo to treat a rare form of anemia 15 months after the regulator rejected the medicine due to manufacturing issues. The French drugmaker said it will begin selling the drug in the U.S. "in coming weeks."
• Sanofi set a list price of $1,800 per 1,100 milligram vial, which comes to about $280,000 per year for people weighing less than 75 kilograms. Up to 5,000 people in the U.S. may have the rare illness, which occurs when the immune system attacks and destroys red blood cells.
• Enjaymo is the first new drug to emerge from Sanofi's $11 billion acquisition of Bioverativ, a blood disease company spun out of Biogen in 2017. A second experimental drug from that transaction, a long-lasting hemophilia treatment called efanesoctocog alfa, is currently in advanced clinical testing.

Sanofi has spent years trying to build a portfolio of rare disease drugs through acquisitions, buying up companies like Genzyme and, more recently, Kadmon and Ablynx. The Bioverativ deal was among those pursuits, giving Sanofi two marketed hemophilia drugs known as Eloctate and Alprolix and other rare disease treatments in various stages of testing.

But Bioverativ was facing competitive hurdles when Sanofi acquired it in 2018. Though the French drugmaker touted the growing market for Eloctate and Alprolix, two so-called factor replacement therapies, new hemophilia treatments were moving fast through clinical testing. One drug from Roche, Hemlibra, has become a multi-billion dollar seller. Experimental gene therapies are inching closer to market as well. In 2021 the combined sales of those two drugs shrank to 977 million euros, or about $1.1 billion.

Bioverativ is paying dividends for Sanofi in other ways, though. The biotech had a pipeline of blood disease treatments, of which Enjaymo, or sutimlimab, was a part. The condition it treats is called cold agglutinin disease, a rare disease in which antibodies mistakenly tag red blood cells for destruction. The disorder causes shortness of breath, fatigue and anemia because patients can't make enough new red blood cells to replace the old ones.

Enjaymo is one of two drugs Bioverativ has been developing for the disorder. The second one, now called SAR445088, is a more convenient version of Enjaymo injected subcutaneously, rather than through intravenous infusions.

Bioverativ's experimental hemophilia drugs were a big part of the acquisition, too, especially as treatment for the genetic disorder continues to evolve. Doctors have been seeking to reduce or eliminate infusions of synthetic bleed-preventing clotting factors, either by developing longer-acting synthetic versions or by manipulating the genes to help patients restart production of their own clotting factor.

Efanesoctocog alfa is the lead hemophilia treatment from Bioverativ and is now in late-stage development as a once-weekly treatment for hemophilia A, compared with a three-to-five day interval for Eloctate. The deal also gave Sanofi an experimental hemophilia B treatment called BIVV002 that could be delivered through more convenient subcutaneous injections.

https://www.biopharmadive.com/news/sanofi-bioverativ-fda-approve-drug-rare-anemia/618416/

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

 

• Pfizer expects to soon reopen enrollment in a late-stage study of its experimental gene therapy for Duchenne muscular dystrophy, indicating Tuesday that a restart could be possible in the "next few months" pending regulatory feedback.
• The Phase 3 trial has been slowed by safety concerns, which led Pfizer to change its design to exclude certain patients who may be at higher risk of a type of heart inflammation. Separately, a volunteer in an earlier, Phase 1 study recently died, resulting in the Food and Drug Administration placing a regulatory hold on the treatment. Pfizer is still investigating the death and the role its treatment may have had.
• Pfizer's gene therapy is one of the most advanced in testing for Duchenne, alongside a treatment being developed by Sarepta Therapeutics. If the drugmaker is able to restart enrollment and testing as planned, it could have results by the end of next year and seek approval thereafter, provided the data are positive.

In addition to laying out expectations for trial progress, Pfizer offered new details on the patient death it disclosed in December, news of which triggered new concerns about the safety of gene therapy in treating Duchenne.

According to Mikael Dolsten, Pfizer's top scientist, the patient, a 16-year-old boy with advanced Duchenne, experienced low fluid volume and cardiogenic shock, a condition in which the heart can't pump enough blood. He was the first trial participant given an immunosuppressive drug called sirolimus as part of his treatment regimen, and had evidence of an active viral infection, Dolsten said on a conference call Tuesday.

"We're investigating how this may have contributed to the outcome," the executive added. "Additional assessment will be required to define next steps to restart the Phase 1b study in non-ambulatory patients who are more progressed in the disease."

Sarolimus is not used in the Phase 3 study testing the therapy in patients who are still ambulatory, which Pfizer hopes to restart soon. Dolsten said the drugmaker, after consulting with a monitoring committee overseeing the study, believes the safety risks are "manageable" in this group.

However, Pfizer previously asked to exclude from the trial patients with certain genetic mutations that may put them at higher risk of heart inflammation. People who meet Pfizer's criteria represent about 15% of the Duchenne population.

Gene therapy safety has been under scrutiny in the past year as unexpected or more serious side effects turned up in clinical trials across several different diseases. Last fall, the FDA convened a meeting of outside experts to discuss some of the most prominent known risks associated with a certain type of gene therapy. The agency has appeared to be closely watching ongoing studies, placing holds on a number of trials after reports of safety-related events.

In addition to Pfizer's treatment, Sarepta is advancing a Duchenne gene therapy and is enrolling a Phase 3 study that could provide results by 2023. The biotech's CEO in January suggested a faster path to a regulatory application for approval may be possible based on recently presented Phase 2 study results.

https://www.biopharmadive.com/news/pfizer-duchenne-phase-3-study-reopen/618642/

Hospital-acquired COVID-19 infections rare and dropping, study suggests

 

• Over the pandemic, many patients have avoided going to the hospital unless absolutely necessary, citing fears of contracting COVID-19. But a new study suggests those fears may have been overblown.
• Rates of acquiring COVID-19 during a hospital stay are low, with only about 1.8% of patients contracting the virus during their stay during the highest weekly pre-omicron peak of cases in December 2020, according to a new study by Epic Research.
• And that rate appears to be decreasing. The data, which covers about a third of the U.S. population, found in-hospital cases of COVID-19 rose and fell in similar patterns to the number of patients admitted due to COVID-19 infection. But in the last half of 2021, the rate of patients who contracted the virus in a hospital rose at only half the rate as overall COVID-19 admissions, likely due to increased vaccination rates among hospital staff, patients and visitors, researchers said.

When the pandemic first hit the U.S. in early 2020, people avoided healthcare facilities in droves, as an influx of COVID-19 patients coupled with a lack of protective gear for healthcare workers and uncertain guidance about avoiding viral spread inflated worries about contracting COVID-19 in hospitals.

Despite the widespread concerns, a new study investigating the frequency with which patients developed COVID-19 while hospitalized found the rate of in-hospital transmission is relatively low, and seems to be dropping as vaccinations become more widespread.

Tracking the spread of COVID-19 inside healthcare facilities in the U.S. is difficult, as HHS only reports data on COVID-19's spread in hospitals on a state-by-state basis. The new study, published Monday in Epic Research, a journal maintained by EHR giant Epic, used a dataset of more than 126 million patients from 156 organizations that use Epic's software, including almost 900 hospitals.

Researchers looked at patients who tested negative on the day of or the day after admission, then tested positive six or more days later. They chose that timeframe to try to exclude patients who may have entered the hospital already positive for COVID-19.

Two research teams worked independently on the analysis before arriving to the same conclusion: Even at COVID-19's peak in late 2020 — before the highly infectious omicron variant sent cases skyrocketing once again late 2021 — only about 1.8% of patients, equating to about 172 individual patients, acquired COVID-19 during a hospital stay the week of Dec. 6.

Researchers noted there is some uncertainty to their findings. The number of in-facility COVID-19 contractions could be an overcount, as the COVID-19 test at admission could be a false negative; or an undercount, as some patients could have been discharged before they tested positive for COVID-19 contracted at the hospital.

Though the weekly rate of hospital-developed COVID-19 compared to total coronavirus hospitalizations is low, it paints a different picture when compounded to the full scope of the pandemic, growing in both volume and severity.

The Centers for Disease Control and Prevention, along with federal and state agencies, has issued guidelines for hospitals to follow to avoid accidentally transmitting COVID-19 from patient to patient. And major U.S. hospitals have also strongly encouraged their workers to get vaccinated, especially following a Biden administration mandate that all staff working in facilities that accept Medicare and Medicaid funding be vaccinated in the first quarter of this year.

Despite those measures, analyses of in-facility transmission suggest hospitals have more work to do to cut down on in-facility transmission, which can be a factor in the life or death of an inpatient.

In November, a Kaiser Health News analysis of federal and state records found more than 10,000 patients were diagnosed with COVID-19 in a U.S. hospital in 2020 after being admitted for an unrelated health need. That's at a rate of 1.7%, a touch lower than the highest rate found in the Epic analysis.

KHN stressed their rate of infection was also likely an undercount.

That data showed about 21% of the patients (who were mostly 65 and older) who contracted the virus in a hospital from April to September in 2020 died, compared to about 8% of other Medicare patients who died in a hospital in the same period.

https://www.healthcaredive.com/news/hospital-acquired-covid-infections-rare-dropping-epic-study/618400/

Healthcare staffing shortages 'rising concern' for medtechs: Moody's

 

• Moody's Investors Service has called out healthcare staffing shortages and supply chain disruptions as two factors that could continue to affect medical device companies into 2022. While shortages of components and elevated shipping costs are expected to be "manageable," hospital capacity constraints could impact procedure-dependent medtechs, according to the Jan. 31 quarterly report.
• Demand for COVID-19 testing has remained elevated for longer than expected, but it's not anticipated to continue at current levels. Still, Moody's expects that rapid at-home tests could provide ongoing revenue for some diagnostics companies, even if at lower levels in the future.
• Medtech companies are expecting another busy year for mergers and acquisitions, though Moody's is forecasting fewer "mega deals." In their most recent earnings calls, Johnson & Johnson and Becton Dickinson referred to smaller tuck-in deals when talking about future acquisitions.

Hospital staffing shortages were top-of-mind for medtech companies going into 2022. During the height of the surge in January, nearly a quarter of U.S. hospitals reported critical staffing shortages, according to HHS data. 

The staffing challenges are expected to linger, according to Moody's latest quarterly report. This could especially affect device makers in the orthopaedics sector, such as Stryker and Zimmer Biomet. Both companies said in recent earnings calls that staffing shortages contributed to lower procedure volumes, as either hospital staff were exposed to COVID-19 or patients themselves were sick. However, demand for surgical robots remained strong. 

As the current surge of omicron cases subsides, and vaccination efforts continue, Moody's expects to see revenues expand due to pent-up demand for deferred procedures. However, if the current variant or a new variant remains widespread, that could change.

While the latest COVID-19 wave has hit procedure-reliant medtechs, diagnostics companies saw an unexpected surge in demand. It's anyone's guess as to whether that will continue. Although testing demand is not expected to remain at current levels, Moody's noted that at-home testing could continue to provide ongoing revenue for some companies.

"As the usage of rapid at-home diagnostic tests gains acceptance, we believe such tests, whether for the coronavirus or other types of diseases, like the flu, will likely become a more permanent feature of the healthcare landscape," Moody's wrote in the report.  

Medtechs also are contending with continued supply chain disruptions going into 2022. Although Moody's said the disruptions should be "manageable," companies are working through shortages of semiconductors and other materials, as well as rising shipping costs.

GE Healthcare said it expects supply chain disruptions to continue through at least the first half of 2022, and Hologic said it anticipates deferring $200 million in revenue in 2022 as shortages of equipment affect shipments of its mammography and imaging devices. Other companies, such as Intuitive Surgical, acknowledged that supply shortages had affected shipments, but not enough to be material to their business.

AdvaMed responded to a report last month from the Department of Commerce, which found the median inventory held by chips consumers, including medical device manufacturers, has fallen from 40 days in 2019 to less than five days in 2021. The medtech lobby continues to call for medical device companies to be prioritized for semiconductors over automotive and industrial companies, which use similar types of chips. 

Finally, Moody's touched briefly on mergers and acquisitions, expecting another active year after 2021's record numbers. Although fewer "mega deals" are expected for 2022, valuations are starting to come down, making for more potential targets.

Analysts with BTIG are watching digital therapeutics, transcatheter mitral and tricuspid valve repair devices, adjustable intra-ocular lenses, and refractive surgery solutions as potential sectors for acquisitions.

In a Feb. 4 note, the analysts wrote that smaller acquisitions have been "an effective strategy for a number of companies (and not necessarily new), but it seems that more have come to the realization that the tuck-in strategy is the best way to ensure a more constant growth cadence is achieved." 

J&J and BD both indicated in earnings calls that they plan to be acquisitive in 2022, with more of a focus on earlier-stage companies and moderately-priced deals. 

https://www.healthcaredive.com/news/moodys-healthcare-staffing-shortages-medtechs/618644/