https://www.bioworld.com/rss en-us The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer. http://www.bioworld.com/articles/706306 Tue, 05 Mar 2024 12:00:00 -0500 https://www.bioworld.com/articles/706306-ema-validates-two-filings-for-daiichi-astrazenecas-adc The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer. http://www.bioworld.com/articles/706191 Mon, 04 Mar 2024 12:00:00 -0500 https://www.bioworld.com/articles/706191-ema-validates-two-filings-for-daiichi-astrazenecas-adc Spain's Sanifit Laboratoris SL, a company developing treatments for calcification disorders, has dosed the first patient in a phase III trial of its lead asset, SNF-472, for the treatment of the rare and sometimes deadly disease calciphylaxis, a calcium accumulation disorder. http://www.bioworld.com/articles/433067 Fri, 14 Feb 2020 12:00:00 -0500 https://www.bioworld.com/articles/433067-sanifit-seeks-benefit-in-pivotal-trial-for-rare-calcification-disorder Syringe and ampoules Ritter Pharmaceuticals Inc. is reeling from the phase III failure of its lead candidate, RP-G28, designed for patients with lactose intolerance. RP-G28 failed to demonstrate statistical significance in its primary endpoint as the top-line data showed it had no or little difference on patients compared to placebo. The data also show RP-G28 missed its secondary endpoints, all of which casts a shadow on the company and its pipeline. http://www.bioworld.com/articles/429328 Mon, 16 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429328-ritter-struggles-as-its-lead-candidate-fails-phase-iii-trial-in-lactose-intolerance Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents Thursday after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms. http://www.bioworld.com/articles/429359 Fri, 13 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429359-tocagen-shares-trounced-after-phase-iii-brain-cancer-trial-results-in-clear-miss Aveo Oncology Inc. is moving closer to a potential NDA filing for its renal cell carcinoma (RCC) drug, tivozanib, following a recently conducted analysis of the ongoing phase III trial Tivo-3. Updated results evidenced "durable improvements" for study participants, all of whom have refractory metastatic RCC, said primary investigator Brian Rini. Company shares (NASDAQ:AVEO) climbed 30.9% to 92 cents Tuesday as Aveo said it would discuss the data with the FDA, which rejected the company's first attempt at approval in RCC in the summer of 2013. http://www.bioworld.com/articles/429555 Wed, 11 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429555-aveo-sees-path-to-potential-fda-filing-for-rcc-drug-in-tivo-3-study Good news from San Diego-based Acadia Pharmaceuticals Inc.'s phase III trial with Nuplazid (pimavanserin) in dementia-related psychosis (DRP) had analysts trotting out music metaphors in reports about the study called Harmony, while talking already about would-be sales of the drug, a selective serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor. http://www.bioworld.com/articles/429851 Tue, 10 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429851-hardly-drp-in-the-bucket-nuplazids-new-indication-rates-acadia-blockbuster DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003. http://www.bioworld.com/articles/429573 Tue, 03 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429573-pharnext-shares-drop-40-as-fda-requests-second-pivotal-trial-in-cmt Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs. http://www.bioworld.com/articles/337949 Wed, 24 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/337949-o-captain-mycapssa-bid-by-chiasma-nails-phase-iii-oral-acromegaly-prize-won Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell. http://www.bioworld.com/articles/330768 Tue, 23 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/330768-not-accordion-to-plan-try-in-pd-delivers-intec-fizzle-phase-iii-dosing-too-low DUBLIN – Shares in Polyphor AG dropped as much as 21% Wednesday as the company shut down two phase III trials of its lead drug candidate, murepavadin, a first-in-class intravenous antibiotic in development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). http://www.bioworld.com/articles/383285 Thu, 18 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/383285-kidney-problems-derail-polyphors-murepavadin-trial "We tried to land on Mars and we got to the moon," Novavax Inc. President of R&D Gregory Glenn told BioWorld, referring to the Gaithersburg, Md.-based firm's phase III trial with the respiratory syncytial virus (RSV) vaccine called Resvax. And it was more than anyone had done thus far, he added. http://www.bioworld.com/articles/359553 Tue, 16 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/359553-novavax-getting-flus-drift-with-vaccine-fda-aboard-finalizing-phase-iii-setup Positive data from one clinical trial evaluating lumateperone in patients with bipolar disorder wasn't enough to lift Intra-Cellular Therapies Inc.'s stock Monday as another trial's failure with the same drug severely dampened the price of shares, while analysts took the long, more optimistic view. http://www.bioworld.com/articles/389724 Tue, 09 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/389724-mixed-clinical-news-for-intra-cellular-is-bad-news-for-stock Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer. http://www.bioworld.com/articles/349783 Wed, 03 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/349783-boston-biomedical-halts-phase-iii-pancreatic-cancer-trial-testing-napabucasin Adding I.V. sildenafil – the active ingredient in Viagra – to inhaled nitric oxide (iNO) therapy for newborns with persistent pulmonary hypertension (PPHN) failed to achieve a statistically significant reduction in treatment failure rates or time on iNO vs. iNO alone in the first part of a phase III study sponsored by Pfizer Inc. http://www.bioworld.com/articles/375361 Tue, 02 Jul 2019 00:00:00 -0400 https://www.bioworld.com/articles/375361-pfizers-sildenafil-fails-to-bolster-common-neonatal-pulmonary-hypertension-treatment As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential... http://www.bioworld.com/blogs/1/post/183 Mon, 28 Oct 2013 14:54:11 -0400 https://www.bioworld.com/blogs/1-bioworld-perspectives/post/183-patient-experience-still-undervalued-in-regulating-drugs How old is our clinical trial system? The first randomized clinical trial was conducted in 1946. British epidemiologist Sir Austin Bradford Hill used randomization to test a pertussis vaccine and a tuberculosis treatment. But according to an article in the British Medical Journal, the concept of randomization was used even earlier, in agriculture experiments in the 1920s. And even before randomization, controlled clinical trials were taking place as early as 1747, when James Lind conducted an experiment in which groups of sailors with scurvy were given various supplements, including citrus fruits. Yet at the recent Foley & Lardner Life Sciences... http://www.bioworld.com/blogs/1/post/95 Fri, 04 Nov 2011 11:18:43 -0400 https://www.bioworld.com/blogs/1-bioworld-perspectives/post/95-world-s-oldest-clinical-trial-and-health-economics-not-far-behind- It looked Monday as if two of biotech’s long-suffering names might finally be biting the dust. Genta Inc. threw in the towel on beleaguered antisense drug Genasense (oblimersen sodium), after a final analysis of a Phase III melanoma trial – and a previous Phase III melanoma trial, and a Phase III chronic lymphocytic leukemia trial, and a Phase III multiple myeloma trial, and a melanoma approval bid, and a CLL approval bid, and a second CLL approval bid – failed. Meanwhile La Jolla Pharmaceutical Co., which already abandoned lupus drug Riquent (abetimus sodium) after years of mixed data and failed... http://www.bioworld.com/blogs/1/post/31 Mon, 23 May 2011 16:42:33 -0400 https://www.bioworld.com/blogs/1-bioworld-perspectives/post/31-ljpc-gnta-not-dead-yet Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities now include many individuals whose genetic heritage is drawn from multiple continental origins.” In other words, there’s no such thing as racial purity. In their paper, which was published in PLoS ONE and which you can find here (http://ow.ly/4YxK6) the team genotyped nearly 1,000 participants of Biobank, a program that collects DNA and plasma samples to aid in genomic and... http://www.bioworld.com/blogs/1/post/30 Thu, 19 May 2011 14:42:02 -0400 https://www.bioworld.com/blogs/1-bioworld-perspectives/post/30-race-to-nowhere Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings, companies testing their experimental drugs in conjunction with pegylated interferon and rebavirin (PR) vs. PR alone may find enrollment and retention challenging, especially for treatment-naïve subjects. In a three-arm study that includes PR alone, patients would be signing up for a 33 percent chance of a year of flu-like symptoms with a cure rate of about 45 percent, at best.... http://www.bioworld.com/blogs/1/post/25 Mon, 02 May 2011 16:43:53 -0400 https://www.bioworld.com/blogs/1-bioworld-perspectives/post/25-hcv-trials-face-daunting-challenge