Search Results for “AI” – Page 33 – media

US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark Office (U.S. PTO) has handed Daiichi the latest win in the saga. For years, the companies have clashed over Seagen’s so-called “‘039 patent,” which covers certain peptides conjugated to an antibody through various linkers. After a 2008 antibody-drug conjugate (ADC) partnership between the drugmakers ended in 2015, Daiichi Sankyo entered into a lucrative agreement with AstraZeneca to work on what became the cancer blockbuster Enhertu. Seagen staked a claim on the AZ contract in a 2020 lawsuit, arguing that the technology used for the med was created under its previous Daiichi ADC partnership. In 2022, a Texas jury found that Daiichi Sankyo stepped on Seagen’s patent willfully, awarding the latter company $41.8 million in royalties. The now Pfizer-owned company took its case a step further by asking for royalties from future U.S. ...
- Source: drugdu
- 146
- January 19, 2024
Blood Test to Track Gene Expression in the Brain Could Help Prevent Neurological Diseases

Encased within a complex network of specialized blood vessels, the brain remains the body’s most protected organ. This intricate structure, while protective against external threats, poses significant challenges for researchers seeking to understand gene expression dynamics and their link to diseases. Addressing this challenge, scientists have now introduced a noninvasive method to track gene expression in the brain, potentially transforming research in brain development, cognitive function, and neurological disorders. The team of scientists at Rice University (Houston, TX, USA) has developed a groundbreaking class of molecules named released markers of activity (RMAs). These RMAs offer a noninvasive solution to measure gene expression in the brain via a simple blood test. Traditionally, assessing gene expression in the brain has been limited to post-mortem analysis or less sensitive and specific modern neuroimaging techniques. The RMA platform, however, introduces a synthetic gene expression reporter into the brain, which synthesizes a protein capable of ...
- Source: drugdu
- 110
- January 18, 2024
Allakos Skin Drug Fails 2 Mid-Stage Tests, Sparks Restructuring to Cut 50% of Staff

Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation. By FRANK VINLUAN The lead therapeutic candidate of Allakos has failed in two mid-stage clinical trials for inflammatory skin disorders, leading the biotech to halt work on the drug. Allakos is shifting its focus to an earlier-stage program in its pipeline but will do so with fewer staff. A corporate shakeup is shaving about half of the company’s workforce. San Carlos, California-based Allakos aims to treat allergic, inflammatory, and proliferative diseases with antibodies that target receptors on cells that create immune responses in the body. By activating inhibitory receptors, these drugs are intended to stop inflammation. Its most advanced drug candidate was lirentelimab, which was designed to target an inhibitory receptor on mast cells ...
- Source: drugdu
- 124
- January 18, 2024
Shanghai Serum Bio-technology Co., Ltd. voluntarily discloses the announcement of obtaining the ethical review approval for Phase II clinical trial of Anti-Viper Venom Serum

Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the “Company”) has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows: The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results ...
- Source: drugdu
- 136
- January 18, 2024
Drug Farm candidate gains rare paediatric disease status

Drug Farm has been granted a rare paediatric disease (RPD) designation from the US Food and Drug Administration (FDA) for DF-003 to treat retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache (ROSAH) syndrome. DF-003 is an alpha-kinase 1 (ALPK1) indicated for the treatment of the rare autosomal dominant disorder ROSAH syndrome. The condition is caused by mutations in the ALPK1 gene, characterised by the symptoms listed in its name. ROSAH syndrome currently has no approved treatments. Drug Farm received FDA clearance of its investigational new drug (IND) application to initiate Phase I studies for the candidate in June 2023, after pre-clinical studies in ROSAH syndrome transgenic mouse models showed significant activity and favourable drug-like properties. If a new drug application for DF-003 is approved by the FDA, the company may be eligible to receive a priority review voucher (PRV) that can be redeemed to receive for any later marketing ...
- Source: drugdu
- 148
- January 17, 2024
Announcement of Zhejiang Hai Zheng Pharmaceutical Co., Ltd. on the Passing of Consistency Evaluation of Generic Drugs for Cycloserine Capsules of the Company

Zhejiang Hai Zheng Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company” or “Haizheng Pharmaceuticals”) has received a Notice of Approval of Supplementary Application for Cycloserine Capsule from the State Drug Administration (hereinafter referred to as the “State Drug Administration”), and the Company’s drug Cycloserine Capsule has passed the generic drug consistency evaluation. (hereinafter referred to as “the State Drug Administration”) issued the “Drug Supplement Application Approval Notice” for Cycloserine Capsule, and the Company’s drug Cycloserine Capsule has passed the consistency evaluation of the quality and efficacy of generic drugs. Cycloserine Capsule is suitable for the treatment of active pulmonary tuberculosis and extrapulmonary tuberculosis (including renal tuberculosis) caused by tuberculosis bacteria that are sensitive to the drug and have been poorly treated with first-line anti-tuberculosis drugs (e.g., streptomycin, isoniazid, rifampicin and ethanol). Cycloserine capsules were developed by Eli Lilly and Company in the United States, and were launched in the ...
- Source: drugdu
- 86
- January 17, 2024
Menopause Startup Launches AI-Powered Hot Flash Care Product

Loewen Cavill, co-founder and CEO of Amira, never expected to work in the menopause space. But then her aunt was unexpectedly hospitalized due to severe menopause symptoms. “She was waking up five times a night for four years [because of hot flashes],” Cavill said in an interview. “Her sleep deprivation got so bad that she had to quit her job, that she would get sick all of the time, that she was no longer herself anymore, that she spent over $10,000 on doctors, naturopaths, and products. One of the things she tried sent her to the hospital with side effects.” Cavill thought her aunt’s experience had to be niche. But after digging deeper and speaking with hundreds of women, she learned that it was actually very common (in fact, three-quarters of women will battle sleep disruptions from hot flashes). This led Cavill to start Amira in 2021. The startup is ...
- Source: drugdu
- 176
- January 15, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 149
- January 15, 2024
Hengrui Pharmaceuticals’ “Double Ai” Combination Study for Advanced Lung Adenocarcinoma Featured in The Lancet Supplement

Recently, the results of the prospective, multicenter, single-arm phase II clinical study of carilizumab in combination with apatinib and albumin paclitaxel in advanced lung adenocarcinoma (CAPAP-lung), led by Prof. Wu Lin of Hunan Cancer Hospital, have been published in The Lancet (IF=15.1) and eClinicalMedicine (IF=15.1), which is a subseries of The Lancet. eClinicalMedicine (IF=15.1).1 The results of the study showed that the first-line treatment of advanced lung adenocarcinoma negative for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations with karelizumab in combination with apatinib (the “double-Ai” combination) and albumin paclitaxel demonstrated a clinically meaningful antitumor effect. Demonstrated clinically meaningful antitumor activity and a manageable safety profile with low hematological toxicity. This study is the first exploration of advanced non-small cell lung cancer (NSCLC) treated with platinum-free chemotherapy in combination with immunologic agents and anti-vascular drugs, and is expected to provide new options for first-line treatment of EGFR/ALK ...
- Source: drugdu
- 95
- January 15, 2024
AcelRx becomes Talphera, adopting new name to reflect pain pivot

AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy. The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022. Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and ...
- Source: drugdu
- 133
- January 12, 2024

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