Search Results for “Clinical Trial” – Page 63 – media

ANKE Bio and SHIJIAN BIOLOGICAL enter into ADC platform technology licensing cooperation

Recently, Anhui ANKE Bio Engineering (Group) Co., Ltd (hereinafter referred to as “ANKE Bio”, stock code: 300009) signed a license agreement with Shanghai Shijian Biotechnology Co. (“ANKE Bio”). According to the license agreement, ANKE Bio has formally obtained the license of EZWi-Fit®, the ADC technology platform of SHIJIAN BIOLOGY, to develop ADC products. During the license period, ANKE Bio will be responsible for the preclinical research, clinical development and commercial production and sales of the developed products in Greater China, and will pay equity payments (including down payment and milestone payments) and a sales commission as a percentage of net sales to SHIJIAN BIO. Shijian Bio acquires an overseas interest in the ADC product. Shijian Bio is a clinical-stage ADC new drug discovery and development company with an ADC clinical pipeline and comprehensive new drug discovery and development capabilities, and has established a new-generation ADC technology platform, EZWi-Fit®, with its ...
- Source: drugdu
- 76
- April 19, 2024
Kind Pharmaceuticals Announces Settlement

HANGZHOU, China, April 17, 2024 /PRNewswire/ — Today, Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC (“Kind Pharmaceuticals”), together with its Chief Executive Officer Dr. Dong Liu and Chief Scientific Officer Dr. Shaojiang Deng, announced a resolution of their recent dispute with FibroGen, Inc. regarding Kind Pharmaceuticals’ hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI) technology. The parties have agreed to withdraw all pending legal proceedings between them regarding this HIF-PHI technology, without payment by either party. HIF-PHIs are a class of compounds that can be used to treat anemia. Kind Pharmaceuticals’ HIF-PHI drug candidate, AND017, is currently being studied in a clinical trial for the treatment of anemia in chronic kidney disease (CKD) patients. As a result of the settlement, Kind Pharmaceuticals remains free to develop AND017 and other HIF-PHIs in its pipeline. Dr. Liu, Chief Executive Officer of Kind, commented: “Kind is pleased that these disputes have been fully ...
- Source: drugdu
- 70
- April 18, 2024
A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
- Source: drugdu
- 126
- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
- 71
- April 16, 2024
UK’s NICE recommends AbbVie’s Aquipta to treat migraines

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
- Source: drugdu
- 145
- April 13, 2024
Study reveals shorter scans for prostate cancer could improve diagnosis

A clinical trial led by researchers from University College London (UCL) and University College London Hospitals NHS Trust Foundation (UCLH) has revealed that removing a step from a three-part MRI scan could make prostate cancer diagnosis quicker, cheaper and more accessible. The PRIME study was funded by Prostate Cancer UK and the John Black Charitable Foundation. Currently the most common form of cancer in men, prostate cancer is responsible for around 52,000 new cases and 12,000 deaths every year in the UK. In the UK, a three-part multiparametric MRI of the prostate is the current standard of care for patients suspected of having prostate cancer, which includes a dye injection as its third step to identify abnormalities to be seen on the MRI scan. In the study, cancer experts from 22 hospitals from 12 different countries recruited 555 patients and performed full-three-part multiparametric scans on them. Radiologists then assessed the ...
- Source: drugdu
- 132
- April 12, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 80
- April 11, 2024
US researchers reveal positive results of personalised vaccine for liver cancer

Researchers from the Johns Hopkins Kimmel Cancer Center and its Convergence Institute have revealed promising results of a personalised vaccine for liver cancer in a clinical trial. Results from the study were published in Nature Medicine and were recently presented at the American Association for Cancer Research’s annual meeting. Recognised as the most common type of liver cancer, hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths globally, with fewer than one in ten patients surviving five years after diagnosis. Researchers took tumour biopsy cells from 36 HCC patients to identify cancer-associated genetic mutations in the tumour to manufacture a personalised vaccine containing DNA for selected mutated genes. Involving 36 patients living with HCC, investigators added a personalised anti-tumour vaccine to Merck & Co’s – known as MSD outside the US and Canada – PD-1 inhibitor therapy, Keytruda (pembrolizumab), a standard immunotherapy. The personalised vaccine works by ...
- Source: drugdu
- 110
- April 11, 2024
Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.Relapse is common in multiple myeloma, and when it happens, a drug that worked for a patient before might no longer help. Two cell therapies already approved for this cancer may now be used in earlier lines of treatment, a regulatory decision that brings additional choices for patients who have exhausted standard multiple myeloma treatment options. Multiple myeloma is a blood cancer that develops in the plasma cells in bone marrow. The expanded FDA approvals announced Friday cover Abecma, from Bristol Myers Squibb and 2seventy bio, and Carvykti, from Johnson & Johnson and Legend Biotech. Both products are CAR T-therapies made by engineering a patient’s own immune cells to go after BCMA, a protein ...
- Source: drugdu
- 95
- April 10, 2024
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 127
- April 10, 2024

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