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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
- 131
- 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
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42

Shanghai, China, March 14, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics and was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and U.S. Food and Drug Administration (FDA). In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC) patients with disease progression on EGFR targeted therapies. Epidermal growth factor receptor (EGFR) belongs to the receptor tyrosine kinases family and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. Mutation or overexpression of EGFR is considered to be closely associated with the occurrence of various solid tumours ...
- Source: drugdu
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- 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
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- 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
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- 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
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- March 18, 2024
Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC

Recently, an Innovation Passport designation has been awarded to serplulimab, Henlius’ self-developed anti-PD-1 mAb (trade name in China: HANSIZHUANG), for the treatment of extensive stage small cell lung cancer (ES-SCLC) by the U.K. Innovative Licensing and Access Pathway Steering Group including the Medicines & Healthcare products Regulatory Agency (MHRA). This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. ILAP steering group consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). It was launched by the MHRA in order to accelerate the development and access to promising medicines. The designation is open to medicinal product that developed for life-threatening or seriously debilitating condition and meet ...
- Source: drugdu
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- March 18, 2024

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