India and China clear needle-free COVID-19 vaccines

 India and China have cleared a new approach in COVID-19 vaccination — two needle-free options, one a squirt in the nose and the other inhaled through the mouth.

Regulators in India authorized Bharat Biotech’s nasal version on Tuesday as an option for people who haven’t yet been vaccinated.

“This step will further strengthen our collective fight against the pandemic,” Indian health minister Mansukh Mandaviya said on Twitter.

It’s not clear how well the nasal version works. Bharat didn’t immediately release results of its studies or say how soon the new option will roll out.

CanSino Biologics announced Sunday that Chinese regulators have approved an inhaled version of the company’s injected COVID-19 vaccine to be used as a booster dose. The company pointed to preliminary results of studies suggesting the inhaled version revved up immune protection after one puff. It’s not clear if that translated to improved effectiveness, or how soon the inhaled booster will be available.

COVID-19 vaccines today are shots, and they’ve saved millions of lives and continue to offer strong protection against severe illness and death, even as more contagious variants of the coronavirus circulate.

But shot-free versions are being explored as a strategy to improve protection against infection, with particular interest in nasal vaccines designed to fend off the virus right where it enters the body. Nearly a dozen possible candidates are in various stages of testing globally, and CanSino’s is one of two inhaled vaccine candidates being developed, according to the World Health Organization.

India’s nasal vaccine was developed by scientists at Washington University in St. Louis and later licensed to Indian vaccine maker Bharat Biotech. The company conducted two trials, giving two doses of the vaccine to 3,100 previously unvaccinated volunteers and as a booster to around 875 volunteers who had received two shots of other COVID-19 vaccines.

Bharat also is seeking clearance for the nasal spray to be used as a booster for the two-thirds of people in India who’ve already been vaccinated.

Bharat’s nasal spray uses a harmless chimpanzee cold virus to deliver a copy of the coronavirus spike protein to the lining of the nose, training the body to react if it encounters the real virus.

CanSino’s inhaled booster uses a similar harmless human cold virus — it’s the company’s one-dose injected vaccine turned into an aerosolized form. The inhaled vaccine was largely tested as a booster for people who had received another Chinese company’s COVID-19 shots.

Ashley St. John, who is an immunologist at the Duke-NUS Medical School in Singapore, said scientists are pursuing nasal and inhaled COVID-19 vaccine options because the immune system has specialized tools to protect different sites in our body in slightly different ways.

“The advantage with nasal vaccines is that it may get rid of the virus before it has a chance to establish itself in the lungs and replicate,” said Dr. Vineeta Bal, an immunologist and professor at the Indian Institute of Science Education Research in Pune city.

The advantages that vaccines sprayed through the mouth have will depend on the size of individual droplets in the spray, Bal added. Large droplets would train defenses in the mouth and parts of the throat, while smaller droplets are expected to travel deeper and reach the lungs.

It also may be easier to administer a squirt in the nose than a shot, especially in low-income countries, said Dr. Michael Diamond of Washington University in St. Louis, who helped create the vaccine licensed to Bharat.

In October 2021, Russia’s Health Ministry allowed early trials of a nasal form of Sputnik V among 500 volunteers, but the status of those trials and the availability of the vaccine remains unclear.

Vaccination rates in India have dipped in the past months with detected cases plateauing. Around 940 million people, or 67% of the population, have received the first two shots, but only 15% of them have received a third booster shot.

https://apnews.com/article/covid-science-health-china-0cfbcd23fa9ff0eb4e2217126a3475ae

Texas State Police Adopt More Aggressive Strategy on School Shootings

 Texas state police have adopted a more aggressive strategy for responding to school shootings after scathing criticism of law enforcement's handling of a massacre in Uvalde that killed 19 children and two teachers.

The Texas Department of Public Safety (DPS) confirmed in an email on Wednesday that it had made changes in the protocol for its officers responding to a mass shooting such as the May 24 massacre in Uvalde, a small town in Texas Hill Country, about 80 miles (130 km) west of San Antonio.

In an emailed statement, DPS also said it had referred five of its officers to the state inspector general for investigation into their actions during the shooting at Robb Elementary School. Two have already been suspended with pay.

The DPS, which includes the Texas Rangers, created an internal committee in July to investigate how its officers responded. It referred the five officers to the state inspector general based on that investigation.

Also in July, DPS Director Steven McCraw sent an email outlining changes in the protocol for DPS officers responding to a mass shooting, the department said on Wednesday. DPS sent a copy of the email to Reuters.

"Officers responding to an active shooter at a school will be authorized to overcome any delay to neutralizing an attacker," McCraw wrote in the July email. "When a subject fires a weapon at a school he remains an active shooter until he is neutralized and is not to be treated as a 'barricaded subject.'"

In the wake of the shooting, criticism of law enforcement's response centered on Pete Arredondo, who was fired last week as the school district's police chief.

According to the DPS, Arredondo acted as "incident commander" in charge of the overall response, though he has said he did not consider himself the commander on scene.

DPS officials said 19 officers waited for an hour in a hallway outside adjoining classrooms where the gunman was holed up with his victims before a U.S. Border Patrol-led tactical team finally made entry and killed the suspect.

A report by state lawmakers, released in July, said a total of 376 law enforcement officers, including more than 90 state police offices, rushed to the school in a chaotic scene marked by a lack of clear leadership and sufficient urgency.

https://www.usnews.com/news/top-news/articles/2022-09-07/texas-police-adopt-more-aggressive-strategy-on-school-shootings-report

Parkinson's breakthrough can diagnose disease from skin swabs in three minutes

 A new method to detect Parkinson's disease has been determined by analyzing sebum with mass spectrometry.

The study, published today in the JACS Au , have found that there are lipids of high molecular weight that are substantially more active in people suffering from Parkinson's disease.

The researchers from The University of Manchester used cotton swabs to sample people and identify the compounds present with mass spectrometry. The method developed involves paper spray ionization mass spectrometry combined with ion mobility separation and can be performed in as little as three minutes from swab to results.

Professor Perdita Barran at The University of Manchester, who led the research said, "We are tremendously excited by these results which take us closer to making a diagnostic test for Parkinson's Disease that could be used in clinic."

The research used a sample group of 79 people with Parkinson's compared with a heathy control group of 71 people.

The study has arisen from the observation of Joy Milne, who discovered that she can distinguish PD in individuals from a distinct body odor before clinical symptoms occur.

Joy has hereditary Hyperosmia—a heightened sensitivity to smells—which has been exploited to find that Parkinson's has a distinct odor which is strongest where sebum collects on patient's backs and is less often washed away.

Sebum is an oily secretion from sebaceous glands under the skin which are connected to the endocrine system. The scientists have found that sebum can be used as a diagnostic biofluid, which is rich in hydrophobic endogenous metabolites.

Altered sebum production is a well-recognized feature of Parkinson's. The sampling procedure they have developed is simple and non-invasive; sebum is collected in clinics from the upper back of patients and posted in the regular mail to the lab.

Describing the new technique Dr. Depanjan Sarkar said, "The sebum is transferred to filter paper from sampling swab, and we then cut this to a triangle, add a drop of solvent, apply a voltage and this transfers compounds from the sebum into the mass spectrometer. When we do this, we find more than 4,000 unique compounds of which 500 are different between people with PD compared to the control participants."

The Manchester team now see this as a major step forward towards a clinical method for confirmatory diagnosis of Parkinson's, for which to date there is no diagnostic test based on biomarkers.

Professor Monty Silverdale, Clinical Lead on this study said, "This test has the potential to massively improve the diagnosis and management of people with Parkinson's disease."

The current and future focus is to translate these findings into a test of clinical utility. This exciting new work also opens the door to possibly diagnosing other diseases through non-invasive sebum analysis and the team along with the University of Manchester have launched a spin out company Sebomix Ltd. to develop this further.

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Sniffing out Parkinson's disease

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More information: Depanjan Sarkar et al, Paper Spray Ionization Ion Mobility Mass Spectrometry of Sebum Classifies Biomarker Classes for the Diagnosis of Parkinson's Disease, JACS Au (2022). DOI: 10.1021/jacsau.2c00300

https://medicalxpress.com/news/2022-09-parkinson-breakthrough-disease-skin-swabs.html

Amylyx Pharma wins FDA advisory committee backing for ALS drug

 https://seekingalpha.com/news/3881055-amylyx-pharma-wins-fda-advisory-committee-backing-for-als-drug

Texas judge rules Obamacare HIV prevention drug mandate unconstitutional

 

The U.S. Affordable Care Act's (ACA) requirement that private insurance plans cover HIV pre-exposure prophylaxis, or PrEP, at no cost to patients is unconstitutional, a federal judge ruled on Wednesday, siding with conservative lawyers who had challenged the measure on religious grounds.

U.S. District Judge Reed O'Connor in Fort Worth, Texas, found that the PrEP mandate stemmed from a recommendation by an illegally appointed advisory body and that it could violate employers' religious freedom. O'Connor had once ruled the entire landmark U.S. healthcare law popularly known as Obamacare unconstitutional.

A group of business owners sued the government in 2020, arguing that the free PrEP requirement, as well as free coverage requirements for contraception and the human papillomavirus (HPV) vaccine, made them "complicit in facilitating homosexual behavior, drug use, and sexual activity outside of marriage between one man and one woman."

O'Connor has not yet ruled on the challenge to the contraceptive mandate, and rejected the challenge to the HPV vaccine mandate. The HPV vaccine sold by Merck & Co prevents cancers caused by the virus.

The U.S. Department of Health and Human Services did not immediately respond to a request for comment. A lawyer for the plaintiffs had no immediate comment.

The plaintiffs' counsel includes the America First Legal Foundation, a group founded by Stephen Miller, who was an advisor to former Republican President Donald Trump.

The PrEP drugs approved in the United States to prevent HIV infection that can cause AIDS are made by Gilead Sciences Inc and by ViiV Healthcare, a joint venture of GSK Plc, Pfizer Inc and Shionogi & Co Ltd. The companies did not immediately respond to requests for comment.

The ACA, former Democratic President Barack Obama's signature achievement, has survived several reviews by the U.S. Supreme Court.

O'Connor, an appointee of former Republican President George W. Bush, declared the entire law unconstitutional in 2018. But the Supreme Court in 2021 ruled Texas and other challengers lacked standing to pursue that case.

https://www.marketscreener.com/quote/stock/SHIONOGI-CO-LTD-6493659/news/Texas-judge-rules-Obamacare-HIV-prevention-drug-mandate-unconstitutional-41716807/

Arcutis Announces Acquisition of Ducentis BioTherapeutics

 

• Leverages Arcutis’ deep dermatology expertise and broad biologics experience to accelerate Ducentis’ lead compound, DS-234, in atopic dermatitis
  

• Lead indication, atopic dermatitis, is a rapidly growing, significantly underserved market with large unmet need

• Checkpoint agonism is a promising emerging pathway for the treatment of atopic dermatitis, with preclinical and clinical validation data suggesting a durable biologic response

• DS-234 offers a potential best-in-class profile, as well as a highly complementary treatment option to roflumilast cream which is in late-stage development for atopic dermatitis

https://finance.yahoo.com/news/arcutis-announces-acquisition-ducentis-biotherapeutics-210000725.html

Mizuho Bolsters Price Target By 55% On Axsome

 

• Mizuho Securities assumes coverage of Axsome Therapeutics Inc 
  AXSM+0.97%+ Free Alerts
  , with a Buy rating and a price target of $76, representing a 25% upside from the last close is 55% above the initial price target of $49. 
• The analyst is conservative on revenues relative to consensus over the near- and mid-term. It is also below consensus on the cost/expense side, finding merit in Axsome's disciplined spending approach.
• Mizuho sees modest novelty in AXSM's candidates, and the markets it addresses feature meaningful branded and generic competition.
• The analyst also notes that a potentially significant opportunity exists given large markets (e.g., major depressive disorder and migraine) and limited efficacy seen with current standards of care. 

https://www.benzinga.com/general/biotech/22/09/28781655/mizuho-bolsters-price-target-by-55-on-this-migraine-stock