Week 43: Nicotine exposure linked to cognitive deficits in mice offspring, new treatments coming down the pipeline, and how the USDA is trying to prevent African Swine Fever from entering the US

Posted on November 2, 2018 in Uncategorized

Week 43 in the News

Nicotine exposure has been associated with cognitive deficits, such as ADHD and Autism Spectrum Disorder.

Researchers at University of Florida College of Medicine experimented with nicotine exposure in male mice and impacts it had on future generations. The study included male mice who were given nicotine treated water, then bred with drug-naïve females. Researchers then took the F1 generation and bred with drug naïve partners to create two generations worth of data.

Through this study, it was determined that the immediate generation exhibited hyperactivity deficits in attention span, and cognitive issues associated with ADHD and Autism Spectrum Disorder in humans. Taking it further, the F2 generation showed learning deficits, leading to an inference that grandchildren of nicotine-treated fathers can also be negatively impacted.

Quoted from the GEN article, “Our data raise the possibility that some of the cognitive disabilities found in today’s generation of children and adults may be attributable to adverse environmental insults suffered a generation or two ago,” suggests Pradeep Bhide, Ph.D., the Jim and Betty Ann Rodgers eminent scholar chair of developmental neuroscience at Florida State University College of Medicine. “Cigarette smoking was more common and more readily accepted by the population in the 1940s, ’50s, and ’60s compared to today. Could that exposure be revealing itself as a marked rise in the diagnoses of neurodevelopmental disorders such as ADHD and autism?”

This study went on to illustrate the effects of paternal health and exposure on their offspring and subsequent generations. A study out of Ohio State University Wexner Medical Center backed up this claim, investigating how moderate exercise in male mice prior to conception impacted their offspring’s glucose metabolism.

A new addition to atypical treatments for treatment-resistant depression

Compass Pathways has received a breakthrough treatment designation from the FDA for accelerating development on their psilocybin therapy designed for treatment-resistant depression.

Currently, Selective Serotonin Reputake Inhibitors (SSRIs) are the most common form of treatment for depression. But this study hopes to introduce psilocybin as an atypical alternative treatment. This is one of a handful of atypical treatments being studied to help with treatment-resistant depression, which includes drugs such as ketamine and N-methyl-d-aspartate (NDMA).

Psilocybin is one of the active ingredients in “magic mushrooms,” and acts differently by inhibiting serotonin-dependent neurons and “resets” the brain.

Compass Pathway stresses that the therapy prescribed alongside this drug is just as important as the drug itself, closely screened before administration and monitored continuously during all phases by specially trained therapists.

After a less than stellar 2017, firms such as Sartorius, Pall, and ThermoFisher have noticed a “return to normalcy” in mid-2018.

Pall’s continued double-digit growth, highlighting biotech growth specifically with single-use systems. Danaher’s life science sector, as a whole, saw an increase in sales up to $1.6 bn with a growth of 9.5% from 2017.

It is said that an increase in single-use systems is a contributing factor to significant company growth across the industry. Sartorius’ Bioprocess Solutions Division also faced a revenue growth at 14.8%  in the first three quarters alone in 2018. This caused a production increase demand in the US market and lead to a $100m expansion of their Puerto Rico production facility.

A new enzyme-blocking flu treatment has earned approval from the FDA.

The antiviral drug approved for the treatment of non-complicated influenza is the first in nearly 20 years. Genentech, a subsidiary of Roche, is the distributor of this drug called Xofluza.

Xofluza is meant to provide an effective alternative to drugs currently available to treat influenza. Andrew Villani, senior manager of corporate relations at Genentech, stated finding new alternatives to treat influenza is important, coming off of severe flu season last year.

The mechanism of action for Xofluza, is blocking an enzyme responsible for replication early in the virus’ lifecycle. He also states that it has shown efficacy against a range of circulating influenza viruses, with two of them being resistant to treatment and avian strains in non-clinical studies.

Xofluza was granted priority review by the FDA, which included action on the application within a shortened timeframe after it was determined that this drug could “significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.”

While it is only approved to help treat individuals who have already contracted influenza, it is said that the best way to combat the flu is by getting a preventative flu shot.

Researchers from Harvard Medical School may have found an insight into the cause of SIDS

The leading cause of death in young infants in the western world is SIDS, or sudden infant death syndrome. The cause of SIDS is still unknown, but new research out of Harvard may indicate that the failure of autoresuscitation in certain infants that show abnormalities in the brain, specifically, their ability to produce serotonin, may be an underlying factor. The story is covered here by GEN.

The autoresuscitation response triggers the body to restore itself to healthy levels by a series of gasps and increases the heart rate when oxygen levels in the cells fall and carbon dioxide levels rise after breathing is temporarily stopped.

This lead researchers, headed up by Susan Dymecki, M.D., Ph.D., professor of genetics from Harvard Medical School, to ask whether autoresuscitation recovery response relies on neurons that produce serotonin.

While this does not account for all cases of SIDS, Dr. Dymecki states that if they can determine whether neurons that produce serotonin play “an active and necessary role” in the regulation of breathing, heart rate, and active recovery responses in cases of apneas found in young mouse pups, it could potentially help provide a biological explanation for the cause of some SIDS cases.

Has Amgen started a war in the drug-making industry?

Dating back to 2015, Amgen and the duo of Sanofi-Regeneron have been battling it out for the sales of their respective versions of PCSK9 drug, Repatha and Praluent, used to treat high cholesterol. Historically, discounts by drug-makers have been made behind the scenes to lower the net cost of drugs, but Amgen upped the ante this week by slashing the list price of Repatha by 60%. This effectively lowered the cost from $14,000 per year to $5,850 before rebates and other discounts. This move is rare in the drug-making industry, challenging Sanofi and Regeneron, while helping patients actually afford this medication. It has been stated by Amgen that 75% of PCSK9 prescriptions made for Medicare patients go unfilled.

Initially, this drug class was highly promoted but faced serious scrutinization with each drug having a list price around $14,000. If patients were able to access it at all, drug-makers were forced to offer large rebates and subsequently lowered its reach in the market.

Amgen’s move follows Gilead’s slashing the price of their hepatitis C drugs, Epclusa and Harvoni last month, with the hopes to open up accessibility and increase new sales.

Read here to see what else these drug makers have to say by FiercePharma.

This week in Animal Health..

Updates on the spread of Africa Swine Fever and impacts of the importation of pork products. African Swine Fever (ASF) is a highly contagious hemorrhagic disease caused by a “hardy” virus and can be deadly to pigs both domestic and feral. Typically found in sub-Saharan Africa, the disease has been known for a while. But recent cases discovered in China and the European Union sparked the US to make extra efforts to prevent the spread of this disease in the US, which can be spread through bodily fluids of infected pigs, or through ticks that feed on infected pigs.

The most virulent viral strain is deadly to all pigs infected but has no known human impacts, and there is no vaccine currently available. The virus spread to China, which impacted areas with the highest pig densities across 29 provinces. China produces half of the world’s swine population, with numbers around half-billion.

The virus has been said to survive for months in salted or cured pork products or animal feed. It can also travel in raw and processed pork, as well as live animals.

Since there is no vaccination against the virus, veterinarians are being urged to include ASF as a differential diagnosis in any pig that exhibits symptoms which include fever, anorexia, skin hemorrhages, and loss of coordination, to name a few. For a full list of symptoms and recommendations, continue reading here.

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) placed restrictions on the importation of pork products from Poland after certain facilities had failed to implement safety protocols to prevent the spread of ASF and other serious diseases to livestock. Upon reinspection, APHIS agreed to lift the restrictions after diligent review of the Polish facilities in question. The agricultural agency also recruited the help of Customs and Border Protection by inspecting passenger bags from the countries under investigation. One of the agents, a USDA trained detector dog named “Hardy,” sniffed out roasted pork products in a traveler’s bag at Hartsfield-Jackson International airport in Atlanta earlier this month. These efforts are to reduce the risk of ASF entering the US, which could potentially devastate the US pork industry.

The team leading up this cause is trained at a facility in Atlanta and is aptly named the “Beagle Brigade.” This team of detector dogs and their handlers are trained to protect major US ports of entry, or anywhere mail or cargo is received, by identifying prohibited agricultural products from entering the country.