Category: Pharma

PBMs
Pharma

California Files Suit Against Several PBMs Over High Insulin Costs

Editorial Team
  • January 18, 2023
  • 3 min read
Chitosans derived from shellfish may spearhead the gel contraceptive revolution Sweden’s Royal Institute has developed a new contraceptive gel with help from the ocean’s creatures. The contraceptive gel is made using chitosans, which are commonly found in the exoskeletons of shrimp, crabs, and lobsters, as well as in the cells of fungi, and unlike mechanical contraceptives such as spermicides, they do not cause vaginal irritation or any damage to the cervix. Scientists are hoping that the gel contraceptive will combine the effectiveness of a hormonal contraceptive with the comfort of a mechanical one to give users the best possible product. Most contraceptives in the market presently use two ways to prevent pregnancy. One is the mechanical way and the other is hormonal. While hormonal contraceptives work by using a small number of hormones to stop ovulation, by thinning the uterus wall to prevent egg implantation, or by thickening the cervical muscles to prevent sperm from entering. Mechanical contraceptives provide a physical barrier against sperm trying to enter the uterus. Common hormonal contraceptives include the pill, progesterone implants, hormonal injections, and the patch. Products like condoms, spermicide, and diaphragms are examples of mechanical contraceptives. Although both these methods help prevent pregnancy with varying efficacy rates, they each have their own set of adverse side effects to take into account. Mechanical contraceptives, may have a higher rate of failure than hormonal contraceptives but hormonal contraceptives can cause many side effects such as headaches, nausea, soreness, or menstrual cycle changes, in fact, they may even increase the risk of strokes and cancer among consumers. In comparison to this, the contraceptive gel that Dr. Thomas Crouzier, a researcher at Sweden’s Royal Institute of Technology, is developing makes use of the vaginal mucus barrier to prevent conception. The gel his team has developed uses tiny, fibrous compounds called chitosans to create a natural barrier inside the vagina, when the chitosans combine with cervical mucus they form a thick, impervious blockade against sperm. “By interacting with the cervical mucus gel, the chitosan closes the pores of the gel, and makes it impossible for the sperm to penetrate it,” Crozier said. To test the efficacy of this gel contraceptive, the team of scientists injected the gel into 8 ovulating sheep. In the experiment, scientists discovered that the gel stopped 98 percent of sperm from making it more than 2 centimeters into the vagina. Only one sheep, sperm was found in the uterus of one sheep after the treatment. Despite making it past the gel barrier the sperm cells were unable to make it to the uterus because the gel gummed up their tails and eventually, the natural acidity of the vagina killed the sperm. However, this does not mean that the gel contraceptive is without flaws. There is still the need for clinical stage experimentation to establish the safety profile and efficacy in women. It is possible that in actual coital situations, the gel performance of the gel may vary. In addition to this, there are also concerns that the gel may alter the composition of the vaginal microbiome leading to conditions like bacterial vaginosis.
Pharma

Chitosans derived from shellfish may spearhead the gel contraceptive revolution

Editorial Team
  • December 10, 2022
  • 3 min read
Japanese company Eisai has not rejected the possibility that its Alzheimer’s drug had a hand in the brain bleeds of two patients. The patients died during the trials but the company insists that the drug was not the cause of the deaths. According to Eisai, the deaths could not possibly be directly credited to lecanemab, which is a drug used to decelerate cognitive decline in patients with early-stage Alzheimer’s by 27%. Lecanemab is being developed in collaboration with Biogen. Both the patients who passed had taken blood-thinning medication and were elderly, one in his 80s and the other in her 60s. Knowing this Eisai told doctors to hold the risk-benefit dialogue with the caregivers before a prescription for patients taking anticoagulation medication. Eisai stood by its monoclonal antibody therapy’s safety, which is the very first to reduce the rate of the condition’s progression in a big trial. It has raised expectations of a new treatment for the disease which is affecting over 50M people globally. Ivan Cheung, the CEO of Eisai US said, “Our assessment is that these deaths cannot be attributed to lecanemab. Of course, we cannot rule out the possibility that lecanemab might have increased the susceptibility of bleeding risk in the brain.” The results of the trial showed that 13 out of about 1,800 participants (Below 1%) died in the first year and a half of the trial. However, none of the fatalities were credited to lecanemab. 7 of the 13 deaths were of people in the placebo group. Two deaths that were alarming for the investors took place during an extension period after the first 18 months. During this period lecanemab was administered in placebo group patients as well. Doctors have long been worried about the chance of swelling and bleeding in the brain due to monoclonal antibodies. According to Eisai, one of the deaths was due to a brain hemorrhage, while the other cause of death was concluded as cardiopulmonary after autopsy. Vice-President of clinical research at Eisai, Michael Irizarry said that there were complicating aspects in both cases and lecanemab does not seem to be directly responsible for the deaths. However, he said that the possibility of its involvement cannot be ruled out. Michael Irizarry also mentioned the need of discussing the benefit-risk concerning lecanemab use for people who are consuming or intend to start consuming anticoagulative medicine. Hostile events befell 14% of the participants in the active drug group while 11.3% of the placebo group participants faced similar problems. Nearly one in six participants (16.7%) who were given the drug went through micro-bleeds in the brain compared to below one in ten (
Pharma

Alzheimer’s drug did not lead to trial patients’ deaths according to Eisai

Editorial Team
  • December 6, 2022
  • 3 min read
A new study suggests that a drug that showed promise in preclinical tests against treatment-resistant cancer might also work against COVID-19. The study, led by Amy S. Lee, Ph.D., a professor of biochemistry at the Keck School of Medicine, demonstrates that GRP78, a chaperone protein previously linked to the spread of other viruses, is crucial to the transmission of SARS-CoV-2, the virus responsible for COVID-19. Furthermore, the study shows that SARS-CoV-2 replication is significantly suppressed when either GRP78 production or activity is blocked or inhibited using a novel targeted drug. For many years, Lee has focused her research on this protein and its connection to cancer. She actually created the first human GRP78 clone. In early 2020, her lab was actively working on several projects involving GRP78's role in cancer, including one that examined the relationship between the protein and the growth of KRAS-mutated cancer cells.  Then COVID came around, leading all labs not focused on COVID-19-related projects to shut down; Lee’s lab was no exception. But when the older writings were looked at, something interesting came up: research on other coronaviruses indicated that they used GRP78 to gain access to cells.  Seeing this, Lee prompted her team to find out whether COVID-19 might be one of those viruses, and indeed, their initial results - published last year - showed that the virus did use GRP78 to enter cells and reproduce. However, whether or not GRP78 was actually necessary for viral replication was unclear. The team infected human lung cells with COVID-19 and monitored the levels of GRP78 to learn the answer. Scientists observed that protein levels rose as infection progressed, so they did the opposite; they prevented the protein from forming in a new set of cells and then infected the virus in them. COVID-19 spike protein and infectious virus production were reduced in GRP78-deficient cells, demonstrating the importance of this protein for viral replication. To find out more about whether targeting GRP78 could help treat COVID-19, the researchers tried a small molecule drug called HA15 on infected lung cells to see if it worked. This drug was designed to combat cancer by binding to GRP78 and blocking its function. The drug cut down on both the size and amount of COVID-19 plaques, and the effect was stronger as the dose went up. The team eventually moved on to using live models. They gave SARS-CoV-2-infected mice injections for three days, starting on the day they got sick. At the end of the time period, there were ten times fewer viruses in their lungs than in the controls. Previous research by Lee with HA15 has shown that it may be effective against KRAS-mutated cancers as well. Although KRAS-mutated cancer had been considered "undruggable," the first drug specifically targeting this subset of the disease, Amgen's Lumakras, was only approved by the FDA last year. In a September paper, Lee's group reported findings that hinted that inhibiting GRP78 with HA15 could be an effective therapeutic approach. The team demonstrated that the drug, in combination with another GRP78 blocker called YUM70, was able to lower KRAS protein levels and tumors in mouse models as well as cell line models.
Pharma

Promising New Drug Could Help Fight Both COVID-19 And Cancer

Editorial Team
  • November 28, 2022
  • 3 min read
abortion pill approval
Pharma

Conservative group Alliance Defending Freedom sues FDA in bid to overturn abortion pill approval

Editorial Team
  • November 27, 2022
  • 3 min read
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