Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
Don Tracy, Associate Editor Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.Akebia Therapeutics announced that the FDA has approved Vafsen (vadadustat) for the treatment of anemia in adults with chronic kidney disease (CKD) who are on dialysis. According to a company press release, the once-daily, oral tablet works as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activating the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. In other words, it copies the body’s response to low oxygen levels. The FDA based the approval was on positive outcomes from the INNO2VATE program and additional safety data from its use in Japan, where it was launched in August 2020. Now approved in 37 countries, Akebia stated that Vafsen has the potential to improve overall outcomes for patients struggling with ...
Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
Beijing, Shanghai & Boston, Mar. 28, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: “In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of ‘drugging the undruggable’. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to ...
It’s reported according to businesswire, AriBio recently announced that it has signed a licensing agreement for the exclusive marketing rights of AR1001, an investigational drug for the treatment of early Alzheimer’s disease, in China at a price of up to US$770 million. Considering the market competition and sales strategy of Alzheimer’s disease drugs in China, the licensee requested that no disclosure be made until the agreed time. The agreement includes an upfront non-refundable payment of 120 billion won (approximately US$90 million), with a total transaction value of up to 5.59 billion yuan (approximately US$770 million), including milestone payments and additional royalties. Upfront payments will begin in mid-2024. AR1001 is a phosphodiesterase type 5 (PDE5) inhibitor in development and an investigational oral drug for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed that AR1001 can inhibit neuronal apoptosis and restore synaptic plasticity, thus having neuroprotective effects. AR1001 also demonstrated a ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
SUZHOU, China, March 22, 2024 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that the phase II clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) were published online in the renowned journal Cell Reports Medicine (IF: 14.3). Professor Li Zhang from Sun Yat-Sen University Cancer Center is the corresponding author of this paper, and Professor Yuanyuan Zhao is the first author. Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 1.06 million new cases of lung cancer, with a total death toll of 0.73 million in year 2022, far exceeding other tumor types. NSCLC accounts for about 80% – 90% of all lung cancers, and ...
Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
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