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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 ...
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- 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
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- 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 ...
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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 ...
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- 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, ...
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- November 18, 2023
BMS Drug Augtyro Gets FDA Approval to Treat ROS1-Positive NSCLC

By Tyler Patchen The FDA has approved Bristol Myers Squibb’s tyrosine kinase inhibitor Augtyro (repotrectinib) to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, augmenting the company’s arsenal of cancer and NSCLC treatments. According to BMS’s Wednesday announcement, the drug is meant to “minimize interaction” that can lead to certain forms of treatment resistance in ROS1-positive NSCLC patients. The FDA approved the drug based on the TRIDENT-1 study evaluating Augtyro in TKI-naïve and TKI-penetrated patients. Results showed that for TKI-naïve individuals, the objective response rate (ORR) was 79%, with a median duration of response of 34.1 months. For patients that were TKI-penetrated and had no chemotherapy, the ORR was 38%, with a median duration of response of 14.8 months. “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, the ...
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- November 18, 2023
New WHO initiative to prioritise endemic pathogens for vaccine development

The World Health Organization (WHO) has commissioned 16 ‘Vaccine Value Profiles (VVPs)’ to prioritise key endemic pathogens to accelerate vaccine development. The VVPs are a result of collaboration between several pathogen and vaccine experts.Led by the Product Development and Research (PDR) team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of vaccines for pathogens that pose the biggest threat to public health and socio-economic burden, particularly in low- and middle-income countries. The forthcoming supplement in the journal Vaccine will feature the VVPs of 16 pathogens with vaccines in late-stage clinical development to provide comprehensive summaries of critical evidence to provide guidance for vaccine funding, research initiatives, and clinical and policy development strategies. They will comprise state-of-the art, publicly available data and information that highlights the current understanding of anticipated vaccine development, the implementation of feasibility studies and the public health impact ...
- Source: drugdu
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- November 17, 2023
Kesin Pharma expands antibiotic reach with liquid suspension approval

Kesin Pharma has announced the availability of a liquid suspension of antibiotic drug metronidazole to treat patients with bacterial infections.Marketed as Likmez 500mg/5mL, the drug is the first-ever ready-to-use oral suspension of metronidazole to receive US Food and Drug Administration (FDA) approval.The medication requires no refrigeration. Offered in a strawberry peppermint flavour, it has a shelf life of two years. The most common adverse reactions to Likmez include nausea, headache, vomiting and diarrhoea. Through a partnership with Saptalis Pharmaceuticals, Kesin is the exclusive US commercialisation partner for Likmez. New York-based Saptalis Pharmaceuticals specialises in the development and manufacturing of generic and branded products in liquid and semi-solid dosage forms. Metronidazole is used to treat skin infections, rosacea, and mouth infections, including infected gums and dental abscesses. It’s also used to treat conditions such as bacterial vaginosis and pelvic inflammatory disease. Following the approval, Kesin Pharma president and CEO Narasimhan Mani said: ...
- Source: drugdu
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- November 17, 2023
Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry. The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.In addition, the trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. Other secondary endpoints include changes in cholesterol levels, triglycerides, waist circumference, systolic blood pressure and serious side effects. The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound—also known ...
- Source: drugdu
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- November 17, 2023

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