- Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)
- Alvotech will be responsible for development and manufacture of the product
Tuesday, May 21, 2024
Alvotech, Dr. Reddy’s to Commercialize Biosimilar Candidate to Prolia® & Xgeva® in U.S., Europe and UK
Phase 2 Trial Results of Biodexa’s Newly-licensed eRapa™ in Familial Adenomatous Polyposis
Biodexa Pharmaceuticals PLC
(“Biodexa” or the “Company”)
Positive Statistically Significant Phase 2 Clinical Trial Results of Biodexa’s Newly-licensed eRapa™ in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the
2024 Digestive Disease Week Annual Meeting
Overall 83% non-progression rate at 6 Months
Statistically Significant decrease in overall mean polyp burden at 6 months (p=0.04)
MangoRx to Introduce Oral Semaglutide and Tirzepatide
Formulations to be marketed as “Slim” and “Trim” as an Oral Dissolvable Tablet (ODT)
Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products in the area of erectile dysfunction (ED), hair growth and hormone replacement therapies is excited to announce the development of proprietary oral formulations of Semaglutide (“Slim”) and Tirzepatide (“Trim”) to aid in weight management. These innovative drugs, currently available predominantly in injectable form, have demonstrated remarkable efficacy in clinical trials. MangoRx’s new oral formulations are poised to revolutionize the weight loss market and capture significant market share.
The GLP-1 receptor agonists’ market, including both Semaglutide and Tirzepatide, is projected to reach over $164 billion in combined revenue by 2032, based on Visible Alpha consensus, ramping up from $37.9 billion in 2023. These are record-breaking revenues for any drug class in the history of drug development.
The oral formulations of Semaglutide and Tirzepatide are set to capture a significant share of this market, offering a convenient alternative to injections. Semaglutide, marketed under the brand names Ozempic® and Wegovy®, and Tirzepatide, marketed as Mounjaro® and Zepbound®, are both glucagon-like peptide-1 (GLP-1) receptor agonists. These drugs have demonstrated impressive weight loss results in clinical trials. In a recent study, patients taking Semaglutide achieved an average weight loss of 15.2% over one year, while those taking Tirzepatide experienced an average weight loss of 15.7%. The oral formulations of Semaglutide and Tirzepatide are designed for daily consumption and are expected to provide similar weight loss benefits without the need for regular injections.
Patient preference studies consistently show a significant majority in favor of oral medications over injectables. This preference is anticipated to drive higher adoption rates and expand the existing market. The shift to an oral formulation offers a more accessible and convenient option for patients, potentially increasing adherence and overall treatment success.
GSK's experimental drug shows promise in reducing severe asthma attacks
GSK's experimental drug met its primary goal of reducing asthma attacks in a late-stage trial, marking a bright spot for a treatment that the British drugmaker expects to make peak annual sales of 3 billion pounds ($3.81 billion).
The drug, called depemokimab, showed "significant and meaningful reductions" in asthma attacks for patients with eosinophilic asthma, GSK said on Tuesday.
This form of asthma is characterised by high levels of eosinophils, which is a type of white blood cell.
The results come as GSK sharpens focus on its respiratory health portfolio, which is currently thriving on the back of back of a strong launch of its respiratory syncytial virus (RSV) vaccine Arexvy.
The company also bought asthma drug maker Aiolos Bio in a deal worth up to $1.4 billion earlier this year.
Depemokimab is one of the 12 major launches that GSK is gearing up for starting in 2025, having said it has the potential to be a major growth driver by the end of the decade.
The drug has the potential to be the first approved ultra-long-acting biologic with a six-month dosing schedule for patients with severe asthma, GSK said.
"Discovered by our scientists in Stevenage, Depemokimab builds on our deep heritage and leadership in respiratory medicine and has the potential to make a real difference to the millions of people whose lives are affected every day by severe asthma," said Tony Wood, GSK's chief scientific officer.
https://www.yahoo.com/news/gsks-asthma-drug-shows-promise-062942039.html
AstraZeneca eyes $80 billion Total Revenue by 2030 and sustained growth post 2030
- Launch of 20 new medicines expected by 2030
- Significant growth from existing oncology, biopharmaceuticals and rare disease portfolios
- Investing in disruptive innovation that will shape the future of medicine and drive long-term growth
- Decoupling carbon emissions from revenue growth
Breakthrough Tag to Genentech Inavolisib for Hormone Receptor-Positive, HER2-Negative Breast Cancer
- The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
- Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment
- This is the 29th Breakthrough Therapy Designation for Genentech’s oncology portfolio, a testament to our enduring ambition to deliver transformative medicines for patients
HPV Vaccination May Trigger Rare And Often Misdiagnosed Autoimmune Brain Disease
by Megan Redshaw, J.D. via The Epoch Times (emphasis ours),
New research suggests the human papillomavirus vaccine (HPV) can trigger a rare autoimmune brain disorder that causes psychiatric or neurological symptoms following vaccination—and is easily mistaken as psychosis in its early stages.
A recently published study in Current Medicinal Chemistry identified a possible relationship between anti-N-methyl-d-aspartate (NMDA) receptor encephalitis and HPV vaccination.
Anti-NMDA receptor encephalitis is an acute autoimmune disorder where the body creates antibodies against the N-methyl-D-aspartate receptors in the brain. NMDA is a receptor of the amino acid glutamate. Glutamate is the most abundant excitatory neurotransmitter released by the brain’s nerve cells and plays a crucial role in learning and memory formation.
When the anti-NMDA antibodies attack the brain, they disrupt normal brain signaling, causing swelling—or encephalitis—and a host of neuropsychiatric symptoms such as hallucinations, cognitive disturbances, paranoia, aggression, epilepsy, movement disorder, impaired consciousness, and speech disorders. It’s these symptoms that often cause the condition to be misdiagnosed in its early stage as psychosis.
The Study
The paper’s author, Hsiuying Wang, is a professor of statistics at the National Yang Ming Chiao Tung University. She looked at microRNA (miRNA) biomarkers to explore the relationship between anti-NMDA receptor encephalitis and vaccination.
“Although vaccines, such as the HPV vaccine, do not directly induce autoimmune diseases, they can potentially induce an autoimmune response or worsen pre-existing autoimmune conditions in certain individuals,” Ms. Wang told The Epoch Times.
Ms. Wang performed a literature search and identified 16 microRNA (miRNA) biomarkers of HPV and studied biomarkers associated with anti-NMDA receptor encephalitis. The analysis revealed at least four miRNA biomarkers that the two conditions commonly share.
According to The Journal of Nutritional Biochemistry, miRNAs regulate a range of developmental and physiological processes and are useful biomarkers for cancer and other diseases.
Using a phylogenetic tree, Ms. Wang then analyzed the relationship of the miRNA biomarkers associated with HPV and anti-NMDA receptor encephalitis, as well as for other viruses related to anti-NMDA receptor encephalitis. A phylogenetic tree is a diagram that illustrates the evolutionary relationships between different organisms.
The study found a high degree of similarity between miRNA biomarkers associated with HPV and anti-NMDA receptor encephalitis or related vaccines when compared to overall miRNAs.
“While the direct causal connection between HPV and anti-NMDA receptor encephalitis is minimal, insights from the microRNA biomarker study underscore the importance of not overlooking the potential link between this condition and HPV vaccination,” Dr. Wang said.
“Therefore, in cases where individuals receiving the HPV vaccine develop psychiatric or neurological symptoms, a diagnosis of anti-NMDA receptor encephalitis should be considered after ruling out other complications,” she added.
Association With COVID-19 Vaccines
Anti-NMDA receptor encephalitis was first identified in 2007 by researchers who saw the condition in women with ovarian tumors. It has since become the second most common immune-mediated encephalopathy and has presented after numerous viral illnesses, including Epstein-Barr and COVID-19. It is also associated with vaccines, including H1N1, yellow fever, TdaP-IPV booster, and COVID-19, primarily in young women.
Another notable characteristic of anti-NMDA receptor encephalitis is that it may be triggered by tumors due to the cross-reactivity with NMDA receptors in tumors containing brain cells. Ovarian, neuroendocrine, mediastinal teratomas, testicular teratomas, and small-cell lung carcinoma have all been reported to be associated with anti-NMDA antibodies.
In a 2021 case report in Frontiers in Neurology, researchers describe a female in her 20s who developed anti-NMDA receptor encephalitis after receiving her first dose of Pfizer’s COVID-19 vaccine. Within a week of being vaccinated, she went to the emergency department complaining of frequent urination.
Her family said she had “increasingly frequent” episodes of anxiety, decreased mental acuity, insomnia, and a “fixation” that she had irritable bowels and kidney disease. Additionally, she experienced delusions that she had COVID-19 and her body was “shutting down,” motor dysfunction, and a transient inability to understand or speak. However, her labs were normal and a physical examination only revealed tachycardia and hypertension, so she was released. The next day she returned and was kept for observation.
After removing her clothes and having a bowel movement on the floor, she was transferred to an inpatient psychiatric unit where she was treated with antipsychotics. She returned to the emergency department after experiencing a seizure, and her cerebral spinal fluid (CSF) revealed anti-NMDA receptor encephalitis.
“The constellation of symptoms (spontaneous defecation, catatonia, sudden encephalopathy without metabolic or infectious findings) coupled with the preliminary CSF results and the history of deterioration after SARS-CoV-2 vaccination led to a strong clinical suspicion of an autoimmune-mediated encephalitis driven by the vaccine,” the paper’s authors wrote.
The researchers said anti-NMDA receptor encephalitis was not considered when the patient initially came to the emergency room because she was experiencing primary symptoms of psychiatric diseases and had no signs of a fever, systemic infection, or inflammation.
Similarly, a 2022 study published in the Journal of Epilepsy Research found that Pfizer’s COVID-19 vaccine may activate anti-NMDA receptor antibodies present before vaccination. According to the case report, a 20-year-old female who unknowingly had an ovarian tumor developed anti-NMDA receptor encephalitis one day after receiving Pfizer’s COVID-19 vaccine.
Her initial symptoms included abnormal behavior, disturbances in comprehension and reading, repetitive questions, and sending inappropriate text messages to friends. Three days after vaccination, the patient experienced a grand mal seizure that took her to the emergency department, where her CSF revealed anti-NMDA receptor encephalitis. After proper treatment, she “returned to usual life.”
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