PharmaFocus Today – Page 240 – media

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
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- 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
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- 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
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- November 10, 2023
Cannabis and derivatives show promise in reducing weight and waist circumference, with nuanced effects on body fat

In a recent study published in the International Journal of Obesity, researchers examined the effects of cannabis on anthropometric measures. Obesity remains a significant global public health concern, with about 650 million adults affected, per the World Health Organization (WHO). Obesity results in metaphysical changes and chronic conditions that reduce life expectancy. Obesity-related complications are linked to excess body fat, an inflammatory condition that disrupts body functioning, resulting in cardiac, vascular, hemodynamic, skeletal, and cerebral malfunctions. Various strategies have been described to reduce fat mass and, thereby, obesity. These include improvements in physical activity standards, adoption of healthy eating guidelines, drug interventions, and surgical interventions. In recent years, Cannabis sativa has been used to treat/relieve symptoms of some diseases. Although it is well tolerated in some conditions, adverse effects have been frequently reported for psychiatric disorders with long-term use. Various diseases have been linked to the therapeutic or recreational use ...
- Source: drugdu
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- November 10, 2023
EU HTA harmonisation may land off key for pharma

Heading towards 2025, pharmaceutical companies have begun preparing for the harmonisation of health technology assessment (HTA) processes in the EU, but the looming change has led to mixed sentiments. “I hope that this will broaden and speed up access…, but realistically, as the process stands now, I am a bit sceptical that it will reach that goal quickly,” said Kevin Rieger, the director of corporate affairs at Beigene. Rieger discussed the upcoming HTA process with Fabian Berkemeier, the managing director at the IGES Institute, at the Bio-Europe conference. In a 7 November panel, Rieger expressed concerns about the logistics of the joint-EU HTA. He highlighted that the new process would rather duplicate the data submissions needed as all requirements for member states would be added into one HTA process, alongside the European Commission’s (EC) own rules. Furthermore, he said that thus far, receiving direct advice meetings with the EC had ...
- Source: drugdu
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- November 10, 2023
Alfasigma opens new doors in the US with Intercept acquisition

Alfasigma has expanded its drug portfolio for treating rare and serious liver diseases after completing its acquisition of US-based Intercept Pharmaceuticals. The completed acquisition comes just over a month after Intercept agreed to a $794m (€751.76m) buyout by Alfasigma. Any remaining common shares of Intercept were bought at $19.00 per share. Now being owned by the leading Italian pharmaceutical company, Intercept will no longer be traded on the Nasdaq exchange. In acquiring Intercept, Alfasigma has gained access to Ocaliva, the only US Food and Drug Administration (FDA)-approved second-line therapy for primary biliary cholangitis (PBC). Ocaliva, in combination with bezafibrate, also has orphan drug designation for PBC that was granted by the FDA in May. As per Alfasigma CEO Francesco Balestrieri, the company seeks to expand its gastroenterology and hepatology market presence and will benefit from Intercept’s innovation and R&D pipeline. Though Intercept’s Ocaliva has had its victories, the drug has ...
- Source: drugdu
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- November 10, 2023

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