PharmaFocus Today – Page 230 – media

Kite and Arcellx expand strategic collaboration

Gilead company Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas. The parties entered an international strategic deal in December 2022 to jointly develop and market a CART-ddBCMA candidate for relapsed or refractory multiple myeloma. Kite has now exercised its licence option for ACLX-001, an ARC-SparX programme of Arcellx in multiple myeloma. Arcellx is entitled to receive an equity investment of $200m in exchange for 3,242,542 shares of its common stock. The funding will offer 13% ownership of Arcellx to Gilead. Arcellx is also eligible to receive $85m in upfront non-dilutive cash payment, separately from milestone payments in the future. The deal will close by the end of 2023. A BCMA-specific CAR-modified T-cell therapy of Arcellx, CART-ddBCMA is currently in a Phase II clinical trial. Kite executive vice-president Cindy Perettie stated: “We are pleased to see the momentum with the CART-ddBCMA multiple myeloma ...
- Source: drugdu
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- November 20, 2023
AstraZeneca shares positive phase 3 results for Imfinzi combination in liver cancer

AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) when used as part of a combination treatment in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer. The phase 3 EMERALD-1 trial has been evaluating Imfinzi plus transarterial chemoembolisation (TACE) followed by Imfinzi with or without Genentech’s Avastin (bevacizumab) until progression versus TACE alone in more than 600 patients with unresectable HCC eligible for embolisation. Approximately 75% of all primary liver cancers in adults are HCC and up to 30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can deliver chemotherapy or radiation therapy directly to the liver. Despite being the standard of care in this setting, most of those who receive embolisation experience rapid disease progression or recurrence. “Patients with liver cancer eligible for embolisation experience high rates ...
- Source: drugdu
- 224
- November 18, 2023
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
- Source: drugdu
- 135
- November 18, 2023
UTS researcher tests new handheld device for rapidly and accurately identifying drug specimens

University of Technology Sydney (UTS) Centre for Forensic Science PhD candidate Harry Fursman is working on two fronts to prevent harm to people who use drugs: He is testing a new handheld device for rapidly and accurately identifying drug specimens and conducting ongoing chemical analysis of used syringes. Drugs that are contaminated or substituted with an unexpected substance are a leading cause of death among people who use drugs. In Sydney last week one person died and two people were taken to hospital due to heroin overdoses, after using what they thought was cocaine. Fursman aims to tackle this significant risk by providing objective insights into current trends and consumption habits among people who are injecting drugs. He will present his research on substance testing at the upcoming International Association of Forensic Sciences (IAFS) conference in Sydney on 20-24 November. Portable drug testing device: MicroNIR Fursman is testing a small ...
- Source: drugdu
- 157
- November 18, 2023
Almirall and Absci announce $650m AI drug discovery partnership for dermatological diseases

Almirall and Absci have announced a drug discovery partnership aimed at developing and commercialising artificial intelligence (AI)-designed treatments for dermatological diseases, with the deal worth over $650m. The collaboration will combine Almirall’s dermatological capabilities with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. Under the terms of the agreement, Absci will apply its de novo generative AI technology to create and commercialise therapeutic candidates for two dermatological targets. In addition to product royalties, Absci is eligible to receive up to approximately $650m in upfront fees, research and development (R&D) and post-approval milestone payments across the two programmes if all milestones are successfully completed. Dr Karl Ziegelbauer, Almirall’s executive vice president of R&D and chief scientific officer, said: “Almirall chose Absci ...
- Source: drugdu
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- November 18, 2023
Roche’s subcutaneous Tecentriq recommended by CHMP for multiple cancer types

Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types. The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer. The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to ...
- Source: drugdu
- 171
- November 18, 2023
New genetic variants linked to prostate cancer in men with African ancestry

Researchers from the Institute of Cancer Research (ICR) and the University of Southern Carolina’s Keck School of Medicine in the US have identified new genetic variants that link to men with African ancestry’s risk of developing prostate cancer. Results from the study could help explain why men of African descent have a greater risk of developing the condition. Published in Nature Genetics, researchers compiled DNA from over 944,000 men of European, African, Asian and Hispanic ancestry – over 150,000 of whom had prostate cancer. Approximately 19,391 of the samples were from men with prostate cancer of African ancestry, offering insight into why they are twice as likely to develop the condition compared to white European men. As a whole, researchers identified 187 new genetic variants linked to men’s risk of developing prostate cancer. Across the UK, more than 52,000 men are diagnosed with prostate cancer every year. The condition affects ...
- Source: drugdu
- 208
- November 18, 2023
Which Tech Solutions Are Actually Having a Positive Impact on the Workforce Crisis?

Knowing that many tech solutions end up being not as effective as health systems would have hoped, two health system executives gave examples of tools they believe have made a significant impact on staffing issues at their organizations. One is a wearable patch that continuously monitors inpatients’ vital signs, and one is a platform that allows providers to fill open shifts with local nurses. By KATIE ADAMS Hospitals across the country continue to grapple with the workforce crisis, with reports showing that nearly half of U.S. healthcare workers plan to leave their roles by 2025. To address this sweeping problem, health systems are working to create workplace cultures that make staff feel supported, as well as adopting tech solutions to offload some of their workers’ daily tasks. But not every piece of shiny new tech will deliver on its promises to ease burnout among staff, Ardent Health Services CEO Marty ...
- Source: drugdu
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- November 18, 2023
FDA Approves Bristol Myers Squibb’s Augtyro for Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Repotrectinib (Augtyro) is a next-generation, potential best-in-class tyrosine kinase inhibitor approved to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer. The FDA has approved Bristol Myers Squibb’s repotrectinib (Augtyro) to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors. The drug was designed to improve the durability of response and with favorable properties that improve intracranial activity. “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” Samit Hirawat, MD, executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb, said in a press release.1 “As the only approved next-generation TKI for ROS1 positive ...
- Source: drugdu
- 180
- November 18, 2023
CorMedix Wins FDA Approval for Antimicrobial Drug Combo After Two Rejections

By Tristan Manalac The FDA on Wednesday approved CorMedix’s DefenCath (taurolidine and heparin) to reduce catheter-related blood stream infections in adults with kidney failure who are on chronic hemodialysis through a central venous catheter. DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S., according to CorMedix’s announcement. CorMedix expects DefenCath to be available in the inpatient setting in the first quarter of 2024. The company’s stock was trading 35% higher Wednesday morning in response to the approval, according to Seeking Alpha. CorMedix CEO Joseph Todisco in a statement said that DefenCath’s approval was a “major advancement” for preventing life-threatening infections and provides doctors “an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure.” DefenCath is a combination of the amino acid derivative taurolidine and the anticoagulant heparin. Taurolidine has demonstrated strong antimicrobial activity against gram-positive and gram-negative bacteria, ...
- Source: drugdu
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- November 18, 2023

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