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Saturday, September 10, 2022

Five Hong Kong speech therapists jailed for sedition over children's books

 Hong Kong jailed five speech therapists for sedition on Saturday over a series of illustrated children's books that portrayed the city's democracy supporters as sheep defending their village from wolves.

They join a growing list of residents jailed under a colonial-era sedition offence which authorities have deployed alongside a national security law introduced by Beijing in 2020 to stamp out dissent.

The group, who are all in their twenties and belonged to a speech therapists' union, have been behind bars for over a year while awaiting a verdict. 

They were all handed a 19-month jail term for a picture book series that began in 2020 to explain Hong Kong's democracy movement to children. The group could be released in 31 days after deductions for time served, one of their lawyers estimated. Three of them struck a defiant tone during Saturday's sentencing. 

Melody Yeung told the court she did not regret her choices and hopes to always stand on the side of the sheep. "My only regret is I couldn't publish more picture books before getting arrested."

Defendant Sidney Ng's lawyer quoted his client as saying the prosecution "had the objective effect of intimidating civil society and alienating Hong Kongers from one another". Judge Kwok Wai-kin scolded the defendents for "brainwashing" children and sowing the "seed of instability" in the city and across China.

The judge, handpicked by Hong Kong's leader from a pool of jurists to hear national security cases, had convicted the group on Wednesday for conspiring to spread seditious content.

'People's history'

Prosecutors had argued the books contained "anti-China sentiment" and were aimed at "inciting readers' hatred against the mainland authorities". In one book, a village of sheep fights off invading wolves, while another portrays the canines as spreading disease in the ovine hamlet.

On Saturday, the judge said the books were "a brainwashing exercise" and there was clear evidence of fear, hatred and discontent being instilled in children's minds. "Once (the children) had internalised this mindset, the seed of instability will be sowed," he said.

But the defendants maintained the books chronicled "history from the people's perspective" and were meant to help children understand systemic injustice in society. "Rather than being seditious, (the books) were recording courageous acts for a just cause," Ng said.

Amnesty International, which recently exited Hong Kong because of the national security law, described the convictions as "an absurd example of unrelenting repression". Hong Kong was a bastion of free expression within China and home to a vibrant and outspoken publishing industry.

But Beijing has unleashed a sweeping political crackdown on the city in response to huge and sometimes violent democracy protests three years ago.

The sedition law, which carries a maximum sentence of two years in jail, was dormant for decades but has recently been embraced by police and prosecutors.

https://www.france24.com/en/asia-pacific/20220910-five-hong-kong-speech-therapists-jailed-for-sedition-over-children-s-books

NYC: Lab Testing NYCHA Samples Gave Bad Results, Water Never Had Arsenic

 Residents at NYCHA's Jacob Riis Houses are still being told to use bottled water to bathe, cook and drink despite the city saying the lab responsible for detecting arsenic has issued a retraction after providing "false results," prompting a water crisis for tenants the past seven days.

The water sampled at the Manhattan NYCHA housing complex never contained arsenic, city officials said. Environmental Monitoring and Technologies, the lab behind last week's test, reportedly admitted to delivering inaccurate results after introducing arsenic to the samples collected from the buildings.

"We have now tested more than 140 points — both at the source and at the point of delivery — and we can confidently say the water at Riis Houses is and has been free of any discernable amount of arsenic since the initial tests were initiated in August," the mayor's press secretary, Fabien Levy, said Friday.

The original samples linked to the positive test result were retested at the same lab this week and came back negative for arsenic, Levy said. That result matches the work of a second vendor the city contracted out to after the first positive result in, he said.

City leaders plan to explore all legal avenues while guaranteeing the end to all work with Environmental Monitoring and Technologies.

Despite the end-of-day revelation, the city is still asking NYCHA residents at the complex to continue to avoid using the water as additional test results come in. Another round of tests for additional contaminants and completed by LiRo Environmental, the second vendor used by the city, is expected to return more answers on Saturday.

"In the meantime, out of an abundance of caution, we are continuing to ask Riis Houses residents not to drink or cook with the water in their buildings until these final test results are returned and analyzed. We continue to provide clean water for anyone who needs it," Levy added.

Prior to the city's announcement that the water at the Jacob Riis Houses did not in fact contain arsenic, some residents said they knew something was wrong with the water even before this week's trouble.

"For a while, the water has been coming out brown," Martha Charles, a resident at the Jacob Riis Houses, said.

As the city continues to wait for the newest round of test results, a federal monitor is asking the city to keep all the documents and testing related to the dangerous levels of arsenic discovered in the water at the Jacob Riis Houses for further investigation.

https://www.nbcnewyork.com/news/local/city-says-lab-testing-nycha-water-gave-bad-results-never-had-arsenic/3858766/

Bristol oral psoriasis med OKd by FDA

 Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years

Pivotal Phase 3 POETYK PSO clinical trials demonstrated superior efficacy of once-daily Sotyktu over placebo and twice-daily Otezla® (apremilast) in improving skin clearance

Sotyktu has a well-demonstrated safety and tolerability profile based on the POETYK PSO clinical trials

https://www.biospace.com/article/releases/-u-s-food-and-drug-administration-approves-sotyktu-deucravacitinib-oral-treatment-for-adults-with-moderate-to-severe-plaque-psoriasis/

GeoVax to Update on Phase 2 Trials for COVID-19 Vaccine, Phase 1/2 Trial for Head and Neck Cancer

 GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today announced that its Chairman & CEO, David Dodd, will present a company overview at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12 at 2:30 p.m. Eastern Standard Time.

A webcast of the presentation will be available at the following link: https://journey.ct.events/view/883f0eb3-d86b-41c6-906b-33bbce4c006e.

For more information or to schedule a one-on-one meeting with management, please visit the conference website at: https://hcwevents.com/annualconference/.

https://www.geovax.com/news/geovax-to-present-at-the-h-c-wainwright-24th-annual-global-investment-conference

Friday, September 9, 2022

Longer-Acting Botox Competitor is Coming

 Wrinkles received some bad news this week: A new, longer-acting competitor to Botox Cosmetic received its first FDA approval. Revance Therapeutics  (RVNC finally overcame manufacturing deficiencies to snag regulatory approval for Daxxify in a specific aesthetic condition.

A pivotal clinical trial demonstrated many patients maintained responses for six months, whereas the benefits of Botox generally last three to four months. The potential to need only two treatments per year is expected to become a significant selling point. Daxxify is also the only product on the market to exclude animal-derived components, which could provide a marginal boost in certain demographics.

Investors are rightfully excited about the possibilities to compete in the aesthetics market with Botox, but the company has greater ambitions for Daxxify that will require additional approvals over the next few years.

What's the Market Opportunity?

Daxxify earned FDA approval specifically for treating glabellar lines, or vertical wrinkles between the eyebrows and on the forehead. It may seem silly to draw such a distinction, but it's important for investors to understand the nuances involved in the approval and overall market for the product.

Drugs such as Botox and Daxxify are called neuromodulators. They're derived from toxins produced by the soil bacterium Clostridium botulinum, which is responsible for botulism. The rare but serious illness is characterized by paralysis in vital body systems caused by the bacterial toxins. However, when the toxins are purified and used in infinitesimally small amounts measured in nanograms, they can locally reduce activity in the nervous system. Neuromodulators have treatment applications in wrinkles, migraines, muscle spasms, and other conditions spanning both aesthetics and therapeutics.

Revance Therapeutics will need to earn separate FDA approvals for each new indication. The first approval will compete with Botox Cosmetic in the aesthetics market, which is generally what most people associate with the world's most famous neuromodulator. AbbVie  (ABBV generated full-year 2021 revenue of $1.4 billion from Botox Cosmetic. It generated $862 million in domestic sales in the first half of 2022, suggesting it's on pace to grow over 20% this year.

That provides a significant opportunity for Revance Therapeutics, but success will take time. Daxxify will need to compete against four different neuromodulators in aesthetics including Botox Cosmetic, Dysport, Xeomin, and Jeuveau. The longer-acting formulation is expected to provide a significant advantage within the competitive landscape.

Wall Street is generally optimistic about the company's ability to achieve success. Revance Therapeutics has built commercial infrastructure for its dermal filler products that can be leveraged to launch and ramp Daxxify. Existing relationships with dermatologists could accelerate market share gain, especially considering the value proposition for doctors.

The long-acting formulation is a key selling point for patients who desire fewer injections. It's also a selling point for dermatologist offices, which can charge more for Daxxify and generate more revenue per patient visit.

https://www.thestreet.com/investing/a-longer-acting-botox-competitor-is-coming

Regeneron could reap big rewards from high-dose Eylea

 Regeneron’s 19% stock surge yesterday added $12bn to its market cap, taking its valuation higher than that of the pharma giant GSK; investors were clearly impressed with data on high-dose Eylea. Two crucial pivotal trials succeeded in showing that the project, given at four-monthly intervals, worked as well as the original formulation, dosed every two months. Long-acting Eylea is a vital component of Regeneron’s defence against biosimilars, which could start in the US in 2024. And because the high-dose product will probably be filed under a new BLA it might be exempt from Medicare price negotiations. Analysts reckon the high-dose product could also help fend off a new rival, Roche’s bispecific Vabysmo, which is also available at long dosing intervals. SVB Securities pointed out that 77% of wet AMD patients managed to stay on high-dose Eylea dosed every four months, versus 45% for Vabysmo on this schedule. Echoing upgrades from across the sellside the bank substantially hiked future Eylea forecasts, adding a huge 30% to their 2030 estimate, to $17bn. Still, Roche recently presented two-year data showing that 45% had improved to 60% at two years, so the Vabysmo threat is far from neutralised.

Eylea vs Vabysmo in wet AMD
 Pulsar (NCT04423718)Tenaya (NCT03823287)Lucerne (NCT03823300)
DrugEylea (control)Eylea
8mg
Eylea
8mg
Eylea
2mg (control)
VabysmoEylea
2mg (control)
Vabysmo
RegimenQ8wkQ12wkQ16wkQ8wkVariableQ8wkVariable
N336335338337334337331
Mean observed BCVA improvement (letters)7.66.76.26.65.85.16.6
   LS mean difference in BCVA improvement (primary endpoint) -0.97-1.14 0.7 0.0
   Non-inferiority p-value* 0.00090.0011    
Patients maintained on dosing interval, without need for regimen modification 79%77% 45%** 45%**
*Non-inferiority (1-sided) p-values are for the difference in least squares mean compared to Eylea with margin of 4 letters. **16wk regimen. BCVA=best corrected visual acuity; LS=least square. 

 

Eylea vs Vabysmo in diabetic macular oedema 
 Photon (NCT04429503)Yosemite (NCT03622580)Rhine (NCT03622593)
DrugEylea (control)Eylea
8mg
Eylea
8mg
Eylea (control)Vaby-smoVabysmoEylea (control)Vaby-smoVabysmo
RegimenQ8wkQ12wkQ16wkQ8wkQ8wkVariableQ8wkQ8wkVariable
N167328163312315313315317319
Mean observed BCVA improvement (letters)9.28.87.910.910.711.610.311.810.8
   LS mean difference in BCVA improvement (primary endpoint) -0.6-1.4 -0.20.7 1.50.5
   Non-inferiority p-value* <0.00010.0031      
Patients maintained on dosing interval, without need for regimen modification 91%89%      
*Non-inferiority (1-sided) p-values are for the difference in least squares mean compared to Eylea with margin of 4 letters. Yosemite and Rhine data are averages of weeks 48, 52 and 56. BCVA=best corrected visual acuity; LS=least square.

https://www.evaluate.com/vantage/articles/news/trial-results-snippets/regeneron-could-reap-big-rewards-high-dose-eylea

Arcutis: New Phase 3 Data in Seborrheic Dermatitis Trial

 

  • Study met its primary endpoint with 80% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59% of patients treated with vehicle (P<0.0001)
  • More than 60% of patients treated with roflumilast foam achieved an itch response at Week 8, with significant improvements at the 2-and 4-week assessments
  • Statistically significant improvements compared to vehicle on all secondary endpoints including scaling and erythema (redness)
  • Roflumilast foam was well-tolerated with no evidence of local irritation
  • New drug application (NDA) submission anticipated in 1Q of 2023