PharmaFocus Today – Page 305 – media

PrecisionLife Licenses OXEGENE Dataset to Develop Personalized Treatments for Endometriosis

PrecisionLife, a leading techbio company driving precision medicine in complex chronic diseases, announced today a data access agreement with the University of Oxford to license the Oxford Endometriosis Gene (OXEGENE) dataset with the aim to develop new personalized treatments for endometriosis patients. Endometriosis is a chronic disease associated with severe pain and infertility. It affects 10% of women globally, but how and why it develops is unknown. On average it takes over 7 years for patients to receive a diagnosis and there are currently no approved diagnostic biomarkers or cures for the disease. The OXEGENE dataset contains anonymized genotype data including disease stage and infertility status, from 1,000 surgically confirmed patients. PrecisionLife’s combinatorial analytics platform is unique in its ability to analyze patient data to better understand the causes of complex chronic disease and achieve mechanistic patient stratification to enable precision medicine where it has not previously been ...
- Source: drugdu
- 150
- July 11, 2023
Sales of Alzheimer’s Drug Leqembi may be Slow Initially But Could Pick up in 2024

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
- Source: drugdu
- 114
- July 11, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
- 119
- July 11, 2023
Novo Nordisk Brings New Round of Lawsuits Against Compounded Versions of Ozempic and Wegovy

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA. “Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.” The defendants are compounding ...
- Source: drugdu
- 127
- July 11, 2023
Cipla Pulls 6 Batches of Asthma Med Albuterol After Inhaler Leak Complaint

Cipla, which was recently hit with a 23-page Form 483 filing from the FDA, is adding to the albuterol supply strain with a U.S. recall of six batches of the asthma med.The company’s voluntary recall of albuterol sulfate inhalation aerosol is a result of a container defect, Cipla said in a filing with the Bombay Stock Exchange. Specifically, a market complaint flagged leakage in one inhaler, the company said. The leak was spotted in the inhaler valve, leading Cipla to pull all of the lots of the drug that used that same batch of valves from U.S. shelves. The company made the move “out of an abundance of caution,” it noted in the release. The lots were manufactured in November of 2021 and expire this November. “Cipla maintains stringent quality processes to assess quality defects and safety issues,” the company said in the filing. “Cipla conducts regular investigation and assessment by committees consisting ...
- Source: drugdu
- 139
- July 11, 2023
Previously Unidentified Proteins Suggest New Way to Diagnose Ovarian Cancer

A study led by Nagoya University in Japan has identified three previously unknown membrane proteins in ovarian cancer. Using a unique technology consisting of nanowires with a polyketone coating, the group succeeded in capturing the proteins, demonstrating a new detection method for identification of ovarian cancer. The study is published in the journal Science Advances. The discovery of new biomarkers is important for detecting ovarian cancer, as the disease is difficult to detect in its early stages where it can most easily be treated. One approach to detecting cancer is to look for extracellular vesicles (EVs), especially small proteins released from the tumor called exosomes. As these proteins are found outside the cancer cell, they can be isolated from body fluids, such as blood, urine, and saliva. However, the use of these biomarkers is hindered by the lack of reliable ones for the detection of ovarian cancer. A research group led by ...
- Source: drugdu
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- July 11, 2023
Substance Use Linked to Long-lasting Brain Changes, Cognitive Decline

An estimated 50 million individuals in the United States struggle with the challenges of cocaine or alcohol use disorders, according to the National Institutes of Health (NIH). Beyond the well-documented health risks, addiction to these substances detrimentally affects our cognitive flexibility, which is the ability to adapt and switch between different tasks or strategies. Although previous research has hinted at this connection, the underlying reasons for this cognitive impairment remain elusive. Cognitive flexibility is a crucial element in various domains of our life, including academic achievement, employment success and transitioning into adulthood. As we age, this flexibility plays an important role in mitigating cognitive decline. A deficiency in cognitive flexibility, however, is linked to academic deficits and a lower quality of life. A study led by Dr. Jun Wang, associate professor in the Department of Neuroscience and Experimental Therapeutics at the Texas A&M University School of Medicine, provides new insight into the ...
- Source: drugdu
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- July 11, 2023
Bilateral total knee arthroplasty may increase risk of complications

Patients undergoing bilateral total knee arthroplasty (TKA) are at an increased risk of several types of complications, as compared with matched patients undergoing unilateral TKA, reports a study in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer. “Patients who underwent simultaneous bilateral TKA were at higher risk of experiencing postoperative complications such as pulmonary embolism, stroke, blood loss anemia, and requiring a transfusion,” according to the report by Nathanael D. Heckmann, MD, and colleagues of Keck School of Medicine of USC, Los Angeles. Study in matched groups of patients clarifies risks of bilateral TKA TKA is a highly effective treatment for patients with advanced osteoarthritis of the knee, decreasing pain and improving function. When both knees are affected, bilateral TKA offers some advantages over sequential unilateral TKA, including less time in the hospital, a single rehabilitation period, and ...
- Source: drugdu
- 119
- July 10, 2023
New program offers hiking adventures for people with younger-onset Alzheimer’s

Starting this July, people diagnosed with Alzheimer’s before age 65 will have a new opportunity to connect with others while exploring the great outdoors through a program called SOAR. The name is an acronym for Shared Outdoor Adventures for Resilience. Offered by the UW Medicine Memory and Brain Wellness Center, SOAR will feature free monthly hikes in the Puget Sound area for small groups of people with younger-onset Alzheimer’s. Each participant brings along a family member or friend. A lifelong recreation specialist from Seattle Parks and Recreation will lead the hikes. Optional transportation is provided. Hikes will be up to 3 or 4 miles. The type of terrain will vary among the different hikes to provide a challenge but still be accessible to a wide range of participants. Volunteer naturalists will join periodically to talk about plants and animals in the region. SOAR will conclude with a nature retreat at ...
- Source: drugdu
- 114
- July 10, 2023
Pfizer invests in biopharma company Caribou Biosciences

Pfizer has invested $25m in the clinical-stage, clustered, regularly interspaced, short palindromic repeats, genome-editing biopharmaceutical firm, Caribou Biosciences. Pfizer purchased 4,690,431 common shares of Caribou at $5.33 per share. Pfizer global product development multiple myeloma vice-president and development head Sriram Krishnaswami will now join the scientific advisory board of Caribou. The investment will be used to progress an immune-cloaked allogeneic CAR-T cell therapy, CB-011. The company is currently evaluating the cell therapy in a Phase I CaMMouflage clinical trial for relapsed or refractory multiple myeloma. The US Food and Drug Administration granted fast track designation for CB-011 in April 2023. The complete ownership and control of the pipeline comprising allogeneic CAR-T and CAR-NK cell therapies will be retained by Caribou. Caribou president and CEO Rachel Haurwitz stated: “We believe Pfizer’s investment in Caribou highlights the potential of our clinical programmes and we are excited to establish this partnership with one ...
- Source: drugdu
- 192
- July 10, 2023

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