Respiratory Virus Szn, Can 3D Printing Repair Brain Injuries?, Updates for Ozempic, FDA Advisory Panel Concerns Regarding Clinical Trial Data for Lung Cancer Drug Lumakras, "Long Colds" & Is it Safe to Take Expired Medications?

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'Tis the season: Respiratory virus season🍂

source: giphy.com

Gist: Canada is gearing up for another busy respiratory virus season, offering seniors an array of vaccines to protect against COVID-19, influenza, pneumococcal disease, and the newly available respiratory syncytial virus (RSV) vaccine.

Nitty-Gritty:

  • COVID vaccines are being updated to combat new variants, with shots from Pfizer and Moderna targeting the XBB.1.5 Omicron subvariant. Novavax's non-mRNA vaccine is still under review.
  • Flu shots are rolling out across provinces. Vaccines for pneumococcal disease protect against infections from the bacteria Streptococcus pneumoniae.
  • The RSV vaccine by GSK, approved for adults 60 and older, defends against a virus that can cause bronchiolitis or pneumonia in vulnerable groups. A limited RSV vaccine supply is expected for the upcoming season.
  • Flu shots are advised annually, while COVID shot timing depends on prior vaccination or infection. Pneumococcal vaccine administration varies, and official recommendations for the RSV shot are pending.
  • Co-administration guidelines indicate COVID and flu shots can be given simultaneously, but RSV's status is unclear.

Big Picture: The introduction of diverse vaccines offers hope for protecting Canada's senior population from serious respiratory illnesses. However, complications arise with regional cost variations, eligibility criteria, and uncertainty around co-administration. Despite potential barriers, experts emphasize the importance of vaccination for seniors due to the heightened risks they face from these diseases. With aging immune systems and existing health conditions, older adults are more susceptible to severe outcomes. Vaccination acts as a crucial shield, reducing the risk of hospitalization and promoting overall health.

Original source: here.


Can 3D printing repair brain injuries?

source: ScienceDaily

Gist: Researchers from the University of Oxford have successfully created a simplified version of the cerebral cortex using 3D printed human stem cells. When implanted into mouse brain tissues, these engineered structures integrated seamlessly.

Nitty-Gritty:

  • Research in Nature Communications details the first 3D printing of neural cells mimicking the cerebral cortex's structure.
  • 70 million people suffer traumatic brain injuries yearly globally; no effective treatments for severe cases.
  • The study fabricated a two-layered brain tissue using human neural stem cells.
  • These printed structures successfully integrated structurally and functionally with mouse brain tissue after implantation.
  • The structures utilized human induced pluripotent stem cells (hiPSCs) that can transform into various human tissue cells.
  • hiPSCs, derived from patients, don't provoke immune responses.
  • To create the brain structures, cells were differentiated, turned into 'bioinks', and then printed.
  • When implanted in mouse brains, the tissues integrated effectively, showcasing communication between human and mouse cells.

Big Picture: This breakthrough can potentially revolutionize treatments for traumatic brain injuries. Beyond this, the 3D printed tissues could aid in drug testing, studying brain development, and enhancing understanding of cognition. The effort underlines the importance of multidisciplinary collaboration and paves the way for creating complex multi-layered brain tissues, inching closer to potential personalized treatments for brain damage.

Original source: here.


The FDA has updated the label of the diabetes drug, Ozempic, to reflect reports of intestinal blockage

source: ABCNews

Gist: The FDA has updated the label of the diabetes drug, Ozempic, to reflect reports of intestinal blockage in some users. Ozempic and Wegovy, its counterpart for weight loss, have surged in popularity recently.

Nitty-Gritty:

  • Drugs use semaglutide, part of the GLP-1 agonists family.
  • This medication mimics a natural hormone that slows food passage in the stomach, leading to longer satiety.
  • Labels of Wegovy and Mounjaro mention potential intestinal blockage; Ozempic's label now includes a similar warning.
  • Label notes that reported reactions come from voluntary reports, and a direct link to the drug isn't always clear.
  • Some users report gastroparesis (stomach paralysis); incidents are considered rare and not necessarily due to the drugs.
  • Novo Nordisk highlights known gastrointestinal side effects with GLP-1 class drugs.

Big Picture: While Ozempic and related drugs have shown benefits for many patients, potential gastrointestinal side effects have been highlighted, warranting increased awareness among users and physicians. Continuous monitoring and communication between manufacturers, regulatory agencies, and the public are crucial for ensuring patient safety.

Original source: here.


An FDA advisory panel raised concerns about the reliability of clinical trial data for Amgen's lung cancer drug Lumakras.

source: BioPharmaDrive

Gist: An FDA advisory panel raised concerns about the reliability of clinical trial data for Amgen's lung cancer drug Lumakras. The panel voted 10-2, indicating doubts about the data's accuracy based on issues found in the Phase 3 trial, CodeBreak 200.

Nitty-Gritty:

  • Lumakras was the first drug to target a frequently mutated gene, KRAS.
  • It received conditional approval in 2021 for metastatic lung cancer.
  • The trial was intended to further validate the drug’s efficacy.
  • Concerns included early patient dropout and inconsistencies in imaging reviews.
  • Advisers emphasized that their skepticism was mainly about the trial's reliability, not Lumakras itself.
  • The FDA plans to decide on full approval by December.
  • Independent reviews of tumor imaging differed considerably from investigators', hinting at trial bias.
  • CodeBreak 200 data indicated a slight benefit in progression-free survival over chemotherapy but no notable difference in overall patient survival.
  • Amgen pledges to continue Lumakras testing and liaise with the FDA for full approval.
  • Mirati Therapeutics, a competitor, saw a share surge of 45% after the news, possibly hinting at increased market potential for its similar drug.

Big Picture: While the FDA advisory panel expressed reservations about the trial's conduct and resultant data, Lumakras's accelerated approval isn't immediately threatened. The FDA seems inclined to explore other pathways to verify the drug's benefits. This episode could provide a potential market advantage to rival firms in the KRAS-targeted drug market.

Original source: here.


Ugh, apparently there is a such a thing as a "long cold"🤧

source: giphy.com


Gist: A recent study introduces the concept of a "long cold," suggesting that some respiratory infections can cause lingering symptoms similar to long Covid.

Nitty-Gritty:

  • Researchers found that post-infection symptoms could persist after respiratory infections other than Covid-19.
  • The study, from Queen Mary University of London, was published in The Lancet’s EClincialMedicine journal.
  • Over 10,000 individuals were surveyed about 16 symptoms associated with long Covid.
  • Both groups—those with Covid-19 and those with other respiratory infections—had a higher likelihood of prolonged symptoms than those with no infections since May 2020.
  • Listed symptoms included fatigue, memory problems, and difficulty concentrating.
  • The research considered other health issues that might influence the reported symptoms.
  • There is historical precedence, with the 1918 influenza pandemic causing lasting symptoms and around 280,000 people in the UK suffering from Chronic Fatigue Syndrome, often triggered by a viral illness.
  • Traditionally, lasting symptoms were studied in severe diseases, but the Covid-19 pandemic shifted this focus to also include non-hospitalized individuals.

Big Picture: The discovery of the "long cold" emphasizes the need for more research on post-infection syndromes and the prolonged symptoms they may induce. It's crucial for both the public and medical community to recognize and address these persisting health challenges. Maintaining health through proper nutrition, sleep, moderate drinking, and regular activity could potentially help prevent conditions like long Covid. Still, it's essential to respect and acknowledge the profound impact such post-infection conditions can have on individuals' lives.

Original source: here.


Is it safe to take expired medications? 💊 Short answer: No.

  • Expiration dates help determine if medicines are safe and effective to use.
  • Using expired medical products can be harmful.
  • Expired medicines can change chemically, decrease in strength, and might not treat illnesses effectively.
  • Some expired medicines, such as antibiotics to treat infection, can promote bacterial growth and contribute to antibiotic resistance as they are no longer potent enough.

For disposal:

  • Follow medicine label instructions.
  • You can return your unused and expired medications to any pharmacy in Canada any day of the year.
  • As per Health Canada, some municipalities and local police forces offer take-back programs. These programs provide safe and easy ways to dispose of unused and expired drugs and health products we have in our homes.

Proper storage ensures medicines stay effective:

  • Follow storage instructions on the label.
  • Store in cool, dry places like dresser drawers or kitchen cabinets.
  • Avoid storing near hot appliances or sinks.
  • Ensure medicines are out of reach of children.

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