PharmaFocus Today – Page 259 – media

Mini-summit to address how informatics can help resolve health effects of climate change

Regenstrief Institute, the International Medical Informatics Association (IMIA), the International Academy of Health Sciences Informatics (IAHSI) and the American Medical Informatics Association (AMIA) are hosting a mini-summit at the AMIA 2023 Annual Symposium to address how informatics can help resolve health issues caused by climate change. The event will bring together national and international experts to form an informatics infrastructure that will highlight and bring exposure to climate change’s effects on health. The event Mini-Summit 2023 — Climate and health: How can informatics help? was planned because of the growing awareness around the effects of climate change on health. Fittingly, the AMIA 2023 Annual Symposium will be in Louisiana, a state drastically affected by multiple manifestations of climate change, including heat waves, droughts, wildfires and saltwater intrusion. During the mini-summit, health informatics professionals will discuss lessons from current environmental challenges and the future of preparing for environmental disasters. Experts will ...
- Source: drugdu
- 171
- November 13, 2023
AstraZeneca Targets Obesity Market with Potential $2B Deal for Early GLP-1 Candidate

Pictured: AstraZeneca office in Gothenburg, Sweden/iStock, Wirestock AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases. Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales. In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene. “We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon ...
- Source: drugdu
- 149
- November 13, 2023
Takeda Wins FDA Approval for Fruquintinib in Certain Colorectal Cancer Patients

The FDA on Wednesday approved Takeda’s fruquintinib for previously treated adults patients with metastatic colorectal cancer. The oral targeted therapy of the VEGF-1, -2 and -3 receptors will carry the brand name Fruzaqla. Fruzaqla’s label covers patients who had received prior lines of treatment with fluoropyrimidine, oxaliplatin and irinotecan chemotherapy, as well as an anti-VEGF agent. In wild-type RAS metastatic colorectal cancer (mCRC), and if medically appropriate, the therapy is also indicated for patients who had previously received anti-EGFR treatment. Wednesday’s approval comes more than 20 days before its scheduled target action date and makes Fruzaqla the “first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status,” according to Takeda’s announcement. “Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” Teresa Bitetti, president ...
- Source: drugdu
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- November 13, 2023
FDA Amends Approved Indication for Keytruda in Gastric Cancer

FDA restricts use of pembrolizumab (Keytruda) combination in the treatment of gastric cancer to patients with certain tumor types. The FDA has amended the currently approved indication for pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy in the treatment of gastric cancer. The agency’s updated indication remains under accelerated approval regulations, but restricts the use of Keytruda to patients whose tumors express PD-L1 with a combined positive score (CPS) of one or more as determined by an FDA-approved test for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA also approved the Agilent PD-L1 immunohistochemistry 22C3 pharmDx companion diagnostic device to help identify patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1. Keytruda is an anti-PD-1 therapy that has been found to increase the immune system’s ability to detect and fight tumor cells. The humanized monoclonal antibody inhibits the interaction ...
- Source: drugdu
- 128
- November 13, 2023
FDA Approves Takeda’s Treatment for Rare Blood Clotting Disorder

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
- Source: drugdu
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- November 13, 2023
Eli Lilly reiterates POINT acquisition plans with tender offer extension

Eli Lilly has substantiated its desire to acquire radiopharmaceutical company POINT Biopharma by extending the expiration date of the tender offer. The offer, which will now give POINT until 5:00 pm ET on 16 November to accept or terminate proceedings, outlined Lilly’s proposal to purchase shares at $12.5 per share in cash, with the condition to purchase a majority of POINT’s outstanding shares. The offer was previously scheduled to expire one minute after 11.59 pm ET on 9 November. As of 8 November, Lilly reported that nearly 15 million shares had been presented and not properly withdrawn. These shares constituted about 14.16% of the issued and outstanding shares of POINT as of the same date. The transaction is making waves at POINT where it has been met by a wall of opposition. As per an amended tender offer statement filed with the SEC on 8 November, POINT has received several ...
- Source: drugdu
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- November 13, 2023
Eli Lilly’s tirzepatide injection approved by MHRA and FDA for weight loss in adults

Eli Lilly’s tirzepatide injection has been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) for weight loss and weight management in individuals aged 18 years and over. Both regulators have authorised the dual GIP/GLP-1 agonist, sold under the brand name Mounjaro or Zepbound, for use alongside a reduced-calorie diet and increased physical activity in adults with a BMI of 30 or more, as well as those with a BMI of 27 or more and at least one weight-related health problem such as pre-diabetes, high blood pressure or high cholesterol. Tirzepatide, which is currently used to treat type 2 diabetes, will be available for weight management as a pre-filled pen to be injected under the skin of a patient’s stomach area, thigh or upper arm. The new indications are supported by the results of two late-stage trials, which demonstrated that obese ...
- Source: drugdu
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- November 13, 2023
Spinal stimulation implant offers new hope for Parkinson’s disease treatment

Researchers from the French National Institute of Health and Medical Research, the French National Center for Scientific Research and the University of Bordeaux in France, along with Swiss researchers and neurosurgeons, have successfully designed and tested a spinal stimulation implant to treat Parkinson’s disease. Conducted in collaboration with the Swiss Federal Institute of Technology in Lausanne and the Lausanne university and hospital (UNIL CHUV), the implant was tested to correct disabling gait disorders, which are associated with 90% of people living with advanced Parkinson’s and are often resistant to treatment. Parkinson’s disease is a neurodegenerative condition which progressively damages and leads to a loss of nerve cells in parts of the brain. Gait disorders are commonly caused by weakness of the hip and lower extremity muscles, such as cerebral palsy, muscular dystrophy and spinal muscular dystrophy. The implant directly stimulates nerve cells in the spinal cord responsible for controlling leg ...
- Source: drugdu
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- November 13, 2023
Janssen reveals positive results for nipocalimab in rheumatoid arthritis

Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA). The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy. Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements such as cartilage and bone. The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease. Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role ...
- Source: drugdu
- 112
- November 13, 2023
Bayer Eyes Break-Up, Management Cuts on Disappointing Q3 Results

By Kate Goodwin Bayer is looking to shake things up with some major company changes after reporting “not acceptable” cash flow for the third quarter on Wednesday. “We’re not happy with this year’s performance,” CEO Bill Anderson said in a statement accompanying third-quarter results that were down against the previous year, while emphasizing a need for redesigning the company to focus only on what’s essential for its mission of “health for all, hunger for none.” As part of a significant, unspecified reduction in its workforce, Bayer will remove “several layers” of management, according to Wednesday’s announcement. The goal is to shift the majority of decision-making from the managers to the people doing the work, Anderson said, adding that 12 layers of management between him and the company’s customers were “simply too much.” The company reported nearly 50 billion euros, or $53.3 billion, in revenue with what Anderson called “zero cash ...
- Source: drugdu
- 132
- November 10, 2023

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