Search Results for “antibody” – Page 45 – media

Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer

Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC). Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable ...
- Source: drugdu
- 98
- November 14, 2023
Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease. The decision makes Ixchiq, which is administered as a single intramuscular injection, the world’s first licensed chikungunya vaccine. Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash. “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added: ...
- Source: drugdu
- 99
- November 14, 2023
FDA Amends Approved Indication for Keytruda in Gastric Cancer

FDA restricts use of pembrolizumab (Keytruda) combination in the treatment of gastric cancer to patients with certain tumor types. The FDA has amended the currently approved indication for pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy in the treatment of gastric cancer. The agency’s updated indication remains under accelerated approval regulations, but restricts the use of Keytruda to patients whose tumors express PD-L1 with a combined positive score (CPS) of one or more as determined by an FDA-approved test for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA also approved the Agilent PD-L1 immunohistochemistry 22C3 pharmDx companion diagnostic device to help identify patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1. Keytruda is an anti-PD-1 therapy that has been found to increase the immune system’s ability to detect and fight tumor cells. The humanized monoclonal antibody inhibits the interaction ...
- Source: drugdu
- 115
- November 13, 2023
Eli Lilly reiterates POINT acquisition plans with tender offer extension

Eli Lilly has substantiated its desire to acquire radiopharmaceutical company POINT Biopharma by extending the expiration date of the tender offer. The offer, which will now give POINT until 5:00 pm ET on 16 November to accept or terminate proceedings, outlined Lilly’s proposal to purchase shares at $12.5 per share in cash, with the condition to purchase a majority of POINT’s outstanding shares. The offer was previously scheduled to expire one minute after 11.59 pm ET on 9 November. As of 8 November, Lilly reported that nearly 15 million shares had been presented and not properly withdrawn. These shares constituted about 14.16% of the issued and outstanding shares of POINT as of the same date. The transaction is making waves at POINT where it has been met by a wall of opposition. As per an amended tender offer statement filed with the SEC on 8 November, POINT has received several ...
- Source: drugdu
- 107
- November 13, 2023
Janssen reveals positive results for nipocalimab in rheumatoid arthritis

Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA). The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy. Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements such as cartilage and bone. The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease. Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role ...
- Source: drugdu
- 105
- November 13, 2023
Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong ...
- Source: drugdu
- 109
- November 9, 2023
Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
- 98
- November 9, 2023
Eli Lilly doubles down on obesity pipeline’s potential

Amidst the rapidly growing revenue share of metabolic disease drugs in its pipeline, Eli Lilly is looking to delve deeper into its pharmaceutical exploration of obesity therapeutics, said medical director Axel Haupt. Haupt was speaking at a panel at the ongoing Bio-Europe 2023 conference, where he said drugs like Lilly’s Mounjaro (tirzepatide) carry potential to be used in for several conditions. The US Food and Drug Administration approved Eli Lilly’s Mounjaro for diabetes in May 2022, followed by the European Union in September 2022. The drug is administered via injection in a once-weekly regimen. Haupt revealed that an FDA approval for Mounjaro for treating obesity could be expected within the next 12 months. Obesity and diabetes treatment would likely not be the only use for Mounjaro, given the presence of GIP receptors in other locations like the adipose tissue, Haupt said. Eli Lilly sees potential use for the drug in ...
- Source: drugdu
- 111
- November 8, 2023
Prelude and AbCellera jump on the ADC train with partnership

Prelude Therapeutics and AbCellera have partnered to jointly discover, develop, and commercialise antibody-drug conjugate candidates (ADCs) for cancer treatment. The collaboration leverages Prelude’s expertise in targeted protein degradation, medicinal chemistry, and clinical development and AbCellera’s antibody discovery and development engine to generate novel precision ADCs. ADCs have been identified as a key innovation area by GlobalData, with multiple companies investing in these therapies. The most recent company to join this trend was MSD (Merck & Co), which signed a collaboration agreement with Daiichi Sankyo to develop and market three ADCs last month. Prelude will be responsible for the clinical development and global commercialisation, whilst AbCellera will lead the manufacturing activities for the ADCs. AbCellera will also have the option to co-promote the ADCs in the US, as per the 1 November press release. AbCellera generated $10.1m in revenue from discovery activity in Q2 2023, as per the company’s financials. AbCellera ...
- Source: drugdu
- 129
- November 5, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
- 99
- November 3, 2023

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