Search Results for “EC” – Page 337 – media

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 ...
- Source: drugdu
- 182
- 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
- 160
- 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
- 123
- 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
- 266
- November 17, 2023
AdventHealth CEO’s 3 Rules For Employee Retention

Healthcare’s shortage of workers might be the biggest issue plaguing the industry. Low staffing levels are not only putting more pressure on workers who are already burnt out, but they’re also leading to employee strikes and a lower quality of patient care.To address this pressing issue, health systems across the country are working to ensure their hospitals are places where workers feel heard and supported. Last week at the Reuters Total Health conference in Chicago, AdventHealth CEO Terry Shaw shared three key pillars that the health system uses to create a people-first culture among its workforce that numbers 92,000 caregivers across nine states. Execs don’t have the best vantage point A few years ago, AdventHealth learned that its executives don’t always have the right answers like they may think they do, Shaw pointed out.“I asked my group of 450 executive leaders to prioritize what they thought our team of ...
- Source: drugdu
- 103
- November 17, 2023
Vicarious delays surgical robot as integration challenges, R&D cuts slow development

Dive Brief Vicarious Surgical has extended the timeline for developing its surgical robot by 12 to 18 months to preserve cash, pushing out an anticipated filing for authorization until early to mid 2026.Seeking to reduce cash burn by up to $20 million next year, the medtech company is downsizing its R&D team and reducing spending on contractors. The changes, which will force Vicarious to do tasks in sequence, rather than in parallel, and “integration challenges” delayed the project. CFO Bill Kelly told investors on a Monday earnings call that the spending plan will enable Vicarious to keep going into 2026, but BTIG analysts warned the company is “walking a very tight rope” and downgraded the stock. Dive Insight Vicarious is developing a surgical robot that is designed to provide abdominal access and visualization through a single port. In July, the company said the integration and build of system units ...
- Source: drugdu
- 102
- November 17, 2023
NeuroOne picks former Cardiovascular Systems VP as new COO

NeuroOne Medical Technologies (Nasdaq:NMTC) announced that it appointed Christopher R. Volker as its chief operating officer (COO). Volker joins the Eden Prairie, Minnesota-based neurotech company from Abbott. He previously served as VP and GM of international at Cardiovascular Systems (CSI), which Abbott acquired earlier this year. “Chris’ appointment further strengthens our executive leadership team and deepens our capabilities as we build for future commercial growth and expansion into other clinical applications,” said NeuroOne CEO Dave Rosa. “We are excited to benefit from his broad experience in business development, commercial expansion, finance and health economics, and reimbursement.”NeuroOne commercially launched its Evo sEEG electrode line in the U.S. earlier this year. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.The company is also targeting an FDA clearance this year for its first therapeutic device, the OneRF ablation system, which uses already-implanted sEEG electrodes to ...
- Source: drugdu
- 89
- November 17, 2023
Pfizer to Cut 500 Jobs at UK Site as Part of $3.5B Cost-Savings Campaign

Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer is planning to lay off around 500 of its staffers and terminate its Pharmaceutical Sciences Small Molecule functions at its facility in Sandwich, Kent in the U.K., according to several media reports on Tuesday.The business scale-back comes amid Pfizer’s sweeping cost-reduction plan announced last month, which will see the company generate $3.5 billion in savings through 2024. At the time, the company noted that the “cost realignment” initiative would include layoffs across its global operations, though the exact number of affected employees is still unknown. Local news outlet Kent Online reported that Tuesday’s layoffs were also part of a redundancy consultation program at the Sandwich site.In an emailed statement to Fierce Pharma, a Pfizer spokesperson clarified that the Sandwich facility would remain operational but “with a different size.” There are currently 940 employees at the U.K. site. It is the latest Pfizer location to ...
- Source: drugdu
- 122
- November 17, 2023
Alkermes Spins Off Oncology Business with $275M to Focus on Neuroscience

Pictured: Cancer cell surrounded by cytokines/iStock, Marcin Klapczynski Alkermes on Wednesday announced that it has completed the spinoff of its oncology business to become a pure-play neuroscience company. Mural Oncology will begin trading on the Nasdaq starting Thursday, with Alkermes shareholders receiving a share of Mural for every 10 shares of Alkermes. Mural is launching with $275 million, which is expected to fund it through the fourth quarter of 2025, and an interleukin-2 cytokine as its most advanced asset. Nemvaleukin alfa is being studied as a monotherapy for advanced mucosal or cutaneous melanoma in Phase II and is in a Phase III study in combination with Keytruda for platinum-resistant epithelial ovarian cancer. The therapeutic is designed to avoid the hallmark toxicities of IL-2 immunotherapies. The studies are potentially registrational with readouts expected in early 2025. Additional assets include therapies targeting IL-18 and IL-12. Mural will nominate a development candidate for each program in ...
- Source: drugdu
- 125
- November 17, 2023
Ipsen, Genfit Build Case for Rare Liver Disease Drug with Phase III Data

By Tristan Manalac Pictured: Illustration of diseased liver/iStock, Mohammed Haneefa Nizamudeen Ipsen and partner Genfit on Monday posted promising data from the Phase III ELATIVE trial for their investigational dual peroxisome activated receptors agonist elafibranor, further building the candidate’s case for regulatory approval in primary biliary cholangitis. More than half of patients treated with elafibranor achieved the study’s primary endpoint of biochemical response, defined as having normal bilirubin concentrations alongside a substantial decrease in alkaline phosphatase levels, maintained below a particular threshold. Only 4% of placebo comparators met these biochemical response criteria. Elafibranor also normalized alkaline phosphatase levels in 15% of treated patients, compared to none in the placebo group. In terms of safety, ELATIVE found that elafibranor was well-tolerated with an adverse event profile that was similar to placebo. Common side effects included abdominal pain, diarrhea, nausea and vomiting. In a statement, Christelle Huguet, executive vice president and head ...
- Source: drugdu
- 199
- November 16, 2023

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