On July 11, encouraging news came from the ETER701 study completed by 72 centers nationwide led by Professor Cheng Ying of Jilin Cancer Hospital. The academic paper Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial was published online in the international authoritative medical journal Nature ETER701 was a study of Chiatai Tianqing’s Benmelstobart and anlotinib in combination with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. The study showed that the median progression-free survival (mPFS) and median overall survival (mOS) of patients included in the current study were the highest in the history of the registry study, and that the combination chemotherapy regimen of Benmelstobart and amlotinib is expected to provide a survival benefit for patients with extensive-stage small cell lung cancer (ES-SCLC). This is another authoritative recognition of Benmelstobart in combination with amlotinib and chemotherapy in the field of extensive-stage small ...
Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative condition where axonal loss leads to irreversible neurological damage and disability. Currently, approximately 2.8 million people globally are affected by MS, though this figure is likely underestimated due to underdiagnosis in underserved and remote areas lacking adequate neurological care and imaging facilities. While no cure exists for MS, available treatments aim to reduce the frequency of relapses, which are linked to nerve cell damage and the progression of the disease. There is a critical need for an accessible, affordable, and accurate blood test that can detect early signs of neuronal injury and disease activity. The neurofilament light chain (NfL) protein has been identified as a key biomarker for nerve cell damage. Now, a new blood test that measures levels of NfL could facilitate earlier detection of MS-related neuronal injury and improve disease management. Siemens Healthineers (Forchheim, Germany), in collaboration with Novartis ...
On July 13, the Phase III clinical trial of recombinant herpes zoster vaccine (CHO cell) of Chengdu MAXVAX Biotechnology Co., Ltd (MAXVAX) completed the enrollment of the first subject in Liangyuan District, Shangqiu City, Henan Province, marking the successful start of the Phase III clinical trial of the recombinant herpes zoster vaccine of MAXVAX. The vaccine product adopts recombinant protein technology route and carries independently developed new adjuvant system MA105, which is the first innovative vaccine with composite adjuvant system with independent intellectual property rights to enter phase Ⅲ clinical trial in China. The results of Phase I and Phase II clinical trials show that it has good safety, tolerability and immunogenicity. Phase III clinical trials will further verify the safety, immunogenicity and protective efficacy of the vaccine in a large sample of people, providing key data for the product’s marketing application. About Herpes Zoster Vaccine Herpes zoster is a ...
Canadian biotech Aspect Biosystems has received a $72.75m government investment to advance its proprietary bioprinting technology. The funding, from the governments of Canada and British Columbia (BC), is set to support a $200m multi-year project to advance Aspect’s clinical biomanufacturing capabilities, full-stack tissue therapeutic platform, and bio-printed tissue therapeutic portfolio. Aspect develops bioprinted tissue therapeutics designed to replace or support specific biological functions. According to the company, these implantable, allogeneic cell-based therapies offer solutions such as retrievable implants, and integrated tissues. Aspect’s tissue therapeutic platform is said to combine the company’s bioprinting technology, therapeutic cells, biomaterials, and computational design. In April 2023, Aspect announced a partnership with Novo Nordisk to produce tissue therapeutics for diabetes. Aspect received $75m from Novo in initial payments, with Novo potentially giving Aspect up to $650m in future payments for each of the four potential products arising from the partnership. The collaboration has so far ...
Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. By Frank VinluanEli Lilly has immunology and inflammation products administered by injection, but the pharmaceutical giant is among the companies interested in bringing patients more convenient pill formulations. Its $3.2 billion acquisition of Morphic comes with a lead drug candidate that’s an oral small molecule in mid-stage development for inflammatory bowel disease. According to deal terms announced Monday, Lilly is paying $57 in cash for each share of Waltham, Massachusetts-based Morphic. That price represents a 79% premium to Morphic’s closing stock price on Friday. The deal, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of this year. ...
European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by ...
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