Search Results for “EC” – Page 277 – media

A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting. By FRANK VINLUAN The concept of an antibody drug conjugate, or ADC, is straightforward: a cancer-killing drug is chemically linked to an antibody that targets the delivery of the therapy to a tumor. This drug class has made progress with several approved products and many more on their heels in clinical development. But there’s still plenty of room to improve on this type of targeted cancer therapy, contends Dominik Schumacher, CEO of Tubulis. When an ADC releases its drug payload too early, it hits healthy tissue and sparks toxic effects, Schumacher said. Also, current ADC designs are restricted in their ability to match the biology of cancer ...
- Source: drugdu
- 151
- March 19, 2024
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
- 120
- 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
- 144
- 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
- 114
- 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
- 124
- 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
- 128
- 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
- 117
- March 18, 2024
Fosun Pharma’s Schizophrenia Drug Anxinqi® Approved for Marketing

On March 13, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd, and its subsidiary, Jinzhou Avanc Pharma Limited Liability Company (hereinafter referred to as Avanc Pharma), jointly developed the application for registration of Aripiprazole Oral Solution (trade name: Anxinqi®). The application for marketing registration of aripiprazole oral solution (trade name: Anxinqi®) jointly developed by Aohong Pharmaceutical Co. The drug is used for the treatment of schizophrenia in adolescents and adults aged 13 to 17 years old. Compared with other psychotropic drugs, it has the advantages of less side effects, significant efficacy, low relapse rate, etc. It is suitable for the long-term treatment of schizophrenia patients with a full course of disease, and it is the first-line anti-schizophrenia drug recommended by many domestic and foreign guidelines. Compared with oral solid preparation, oral solution has good fluidity, easy to take, precise and convenient dosage ...
- Source: drugdu
- 159
- March 18, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 160
- March 18, 2024
2024 AACR | Latest research results on garsorasib (D-1553 tablets, KRAS G12C inhibitor) to be announced soon

The annual meeting of the American Association for Cancer Research (AACR) will be held on April 5-10, 2024 local time in San Diego, USA. At the meeting, Yifang Bio will present the latest results from the Phase II clinical trial of garsorasib (D-1553) in patients with non-small cell lung cancer (NSCLC) with KRAS G12C mutation. This will mark the study’s (NCT05383898) appearance at a prestigious international academic conference following the World Conference on Lung Cancer (WCLC) 2022. About Garsorasib KRAS mutations are widespread in several highly lethal cancer types, with KRAS G12C being a specific KRAS mutation that accounts for approximately 44% of all KRAS mutations.KRAS G12C mutations are more common in lung, colorectal, pancreatic, and bile duct cancers. According to Frost & Sullivan, from 2016 to 2020, the number of incidence of major KRAS G12C-mutated cancers in China increased from 38,000 to 43,000, and is expected to reach 58,000 ...
- Source: drugdu
- 166
- March 18, 2024

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