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NHS to roll out AI to improve waiting times and reduce missed appointments

Every year, missed hospital appointments are estimated to cost the NHS £1.2bn The NHS has announced that it’s set to roll out artificial intelligence (AI) to help improve waiting times for elective care and reduce the number of missed appointments. New data has shown that 6.4% of over 125 million outpatient appointments across the NHS in England last year were not attended by the patient, specifically for physiotherapy, cardiology, ophthalmology, trauma and orthopaedics. Additionally, missed appointments are predicted to cost the NHS a total of £1.2bn, annually. Created by Deep Medical, the AI software uses algorithms and anonymised data to predict missed appointments and uses a range of external insights as to why, such as the weather, traffic, jobs and back-up bookings. Piloted for the last six months at Mid and South Essex NHS Foundation Trust, the software will expand to ten more NHS trusts following the success of the ...
- Source: drugdu
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- March 19, 2024
NIHR reveals phase 1/2 trial to evaluate an investigational vaccine for mpox in the UK

More than 3,700 cases of mpox have been identified in the UK since May 2022 The National Institute for Health and Care Research (NIHR) has announced a new phase 1/2 trial, delivered by the NIHR Clinical Research Network and sponsored by Moderna, to test the effectiveness of an investigational mRNA vaccine for mpox. The mPower trial will evaluate the safety and immune response to mRNA-1769, which aims to protect against illness caused by the mpox virus. Currently a global public health threat, mpox is an infectious disease caused by the monkeypox virus, which is spread through physical contact with someone who is infected, leading to symptoms including painful rashes, enlarged lymph nodes and fever. Since May 2022, over 3,700 cases of mpox have been identified in the UK, the majority of which have been from the Clade II B.1 lineage, predominantly in gay, bisexual and other men who have sex ...
- Source: drugdu
- 155
- March 19, 2024
BeiGene’s “tislelizumab” FDA approved

On March 15, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: BAIZEAN®; English trade name: TEVIMBRA®) as mono-therapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (without PD-1/L1 inhibitors). Tislelizumab is expected to be available in the United States in the second half of 2024. The approval was based on results from the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. Tislelizumab demonstrated a statistically significant and clinically meaningful survival benefit compared with chemotherapy. In the ITT population, median overall survival (OS) was 8.6 months (95% CI: 7.5, 10.4) in the tislelizumab group compared with 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab is superior to that of chemotherapy. The most common ...
- Source: drugdu
- 132
- March 19, 2024
FDA approves Mirum’s Livmarli to treat cholestatic pruritus in rare liver disease patients

The US Food and Drug Administration (FDA) has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Estimated to affect one in every 50,000 to 100,000 births in the US and Europe, PFIC is a rare genetic disorder that causes progressive liver disease, typically leading to liver failure. Signs and symptoms of the condition usually begin in infancy and include severe pruritus (itching), jaundice and a failure to grow at the expected rate. The FDA’s decision on the therapy covers a broad range of PFIC subtypes and is supported by positive results from the late-stage MARCH study, which included 93 patients across a range of genetic PFIC forms as well as unidentified mutational status. Results showed a “highly statistically significant” reduction in pruritus severity for those receiving Livmarli compared with placebo, Mirum outlined. Chris Peetz, ...
- Source: drugdu
- 135
- March 19, 2024
Biotheus Expanded Their Partnership with Hansoh Pharma for Developing EGFR/cMET Bispecific Antibody-Drug Conjugates

ZHUHAI, China, March 15, 2024 /PRNewswire/ — On March 14, 2024, Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China’s leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product). Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net ...
- Source: drugdu
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- March 19, 2024
ImmVira’s oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment

SHENZHEN, China, March 15, 2024 /PRNewswire/ — ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence ...
- Source: drugdu
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- March 19, 2024
Intuitive lands FDA clearance for new da Vinci robot

Dive Brief Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition. The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics. The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients. Dive Insight Intuitive is preparing for competitive challenges from Medtronic and Johnson & Johnson, as well as a wave of startups hoping to vie for a piece of the growing market. The robot maker, which saw its procedure volumes increase by 21% in the fourth ...
- Source: drugdu
- 137
- March 18, 2024
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site

Dive Brief Fresenius Kabi has received a warning letter related to the large-volume infusion pumps that it acquired through its $240 million takeover of Ivenix. The Food and Drug Administration sent the letter after inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System. Fresenius took too long to complete investigations, the inspectors found, and failed to establish certain procedures. FDA inspectors visited the site in Massachusetts five months after Fresenius began recalling Ivenix infusion pumps in response to a leak risk that could cause the devices to fail. Dive Insight Fresenius bought Ivenix to strengthen its medtech business, particularly in the U.S., and support its growth strategy. Management has called for patience as Ivenix rolls out its new pump, with Fresenius CEO Michael Sen telling investors that “any new product takes time to hit [its] stride” on an earnings call in February. The ...
- Source: drugdu
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- March 18, 2024
AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. By FRANK VINLUAN AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This ...
- Source: drugdu
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- March 18, 2024
FDA Approves Madrigal Pharma NASH Drug

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence. By FRANK VINLUAN A chronic metabolic disease in which fat buildup leads to worsening liver function that can ultimately require an organ transplant now has its first FDA-approved therapy, a once-daily pill developed by Madrigal Pharmaceuticals. The FDA decision Thursday is for adults with noncirrhotic non-alcoholic steatohepatitis, or NASH. The approval specifically covers those who have reached the point of moderate-to-advanced liver scarring, which is also called fibrosis. The Conshohocken, Pennsylvania-based company’s drug, known in development as resmetirom, will be marketed under the brand name Rezdiffra. “We’ve had patients waiting and waiting for something that could impact underlying fibrosis in the setting of NASH, and this truly represents a milestone achievement that frankly I, and many ...
- Source: drugdu
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- March 18, 2024

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