https://www.fiercebiotech.com/ en https://www.fiercebiotech.com/ai-and-machine-learning/newrons-schizophrenia-add-improves-symptoms-charging-case-phase-3-test Newron Pharmaceuticals’ add-on schizophrenia treatment improved both positive and negative symptoms as well as severity in patients with the disorder during a phase 2/3 study. Apr 30, 2024 9:17am Annalee Armstrong https://www.fiercebiotech.com/a1a173dc-3a92-4098-b79b-f9df6c1d52b2 https://www.fiercebiotech.com/sponsored/decentralized-clinical-trials-patient-experience-and-role-supply-chain-management-0 The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. Jun 29, 2022 2:25pm Questex Partner https://www.fiercebiotech.com/e8552eba-9439-4e3e-b56a-95b008cb31eb https://www.fiercebiotech.com/clinical-data/adc-records-another-phase-2-win-setting-stage-second-approval-request-lymphoma Following the company’s first drug approval in 2021, ADC Therapeutics is looking for FDA nods, and appears to have landed on phase 2 data for a Hodgkin lymphoma drug that could do just that.  Jun 10, 2022 10:01am Max Bayer https://www.fiercebiotech.com/0a7bc6f2-6acc-4e85-877d-12ea399d5a39 https://www.fiercebiotech.com/clinical-data/biontech-touts-early-data-roche-partnered-cancer-combo-hinting-it-could-dent-prostate BioNTech says early data of its Roche-partnered cancer combo shows promise in stemming the recurrence of pancreatic cancer. The early data of 16 patients found that half exhibited longer recurrence-free survival. Jun 3, 2022 2:16pm Max Bayer https://www.fiercebiotech.com/5d9233af-2ded-404d-a05a-a903a5298efd https://www.fiercebiotech.com/clinical-data/bristol-myers-heart-drug-helps-patients-avoid-heart-procedures-countdown-fda-decision Bristol Myers Squibb is presenting data this weekend that shows its targeted heart drug mavacamten helped reduce the risk of needing septal reduction therapy. Apr 1, 2022 2:31pm Annalee Armstrong https://www.fiercebiotech.com/749445c3-94b2-4dd5-9ffc-33cdfb4c7937 https://www.fiercebiotech.com/r-d/university-utah-s-smart-glasses-change-focus-automatically University of Utah researchers have developed “smart glasses” that mimic the function of the eye’s lens and automatically focus on what an individual is looking at. Apr 12, 2017 11:29am Amirah Al Idrus https://www.fiercebiotech.com/146bd1e8-791a-4e2d-bd98-d433d3370aac https://www.fiercebiotech.com/r-d/deep-brain-stimulation-shows-promise-tourette-syndrome Scientists at New York University’s Langone Medical Center reported data from a study showing that deep brain stimulation decreased the severity of tics for patients with Tourette syndrome. Apr 10, 2017 11:33am Amirah Al Idrus https://www.fiercebiotech.com/0160f4df-f0c2-439d-9805-4041736fe550 https://www.fiercebiotech.com/r-d/study-akili-s-project-evo-improves-symptoms-for-kids-spd-inattention Akili Interactive, which is developing video game-based therapies for neurological disorders, announced data showing its platform improved symptoms in children with sensory processing disorder. Apr 5, 2017 2:13pm Amirah Al Idrus https://www.fiercebiotech.com/440dadfd-4402-4cac-8ce4-c13b3e0ca489 https://www.fiercebiotech.com/r-d/novocure-s-device-chemo-combo-boosts-survival-pancreatic-cancer Novocure, which markets a wearable device that treats brain cancer, unveiled positive survival data for the phase 2 pilot trial of its noninvasive therapy in patients with pancreatic cancer. Apr 3, 2017 8:34am Amirah Al Idrus https://www.fiercebiotech.com/69fb20f8-6381-4868-b9cc-31252c9dfc35 https://www.fiercebiotech.com/r-d/bristol-myers-replaces-cso-at-key-point-for-pipeline Bristol-Myers Squibb has appointed Thomas Lynch to replace Francis Cuss as CSO. The reshuffle puts the former CEO of Massachusetts General Physicians Organization in charge of returning the lustre to Bristol-Myers’ R&D pipeline after a period in which setbacks to Opdivo have dampened expectations. Mar 9, 2017 8:45am Nick Paul Taylor https://www.fiercebiotech.com/1c546c5f-1726-4245-9b10-dd4534fbf651 https://www.fiercebiotech.com/r-d/ibm-illumina-join-push-to-personalize-leukemia-treatment IBM and Illumina have joined an initiative to enable personalized leukemia treatment strategies. The program brings the computing and sequencing capabilities of IBM and Illumina to Munich Leukemia Laboratory, which plans to use them to equip physicians with information to guide treatment decisions. Mar 8, 2017 10:17am Nick Paul Taylor https://www.fiercebiotech.com/63b1b5ee-5b89-4472-a87a-659966ecf6d2 https://www.fiercebiotech.com/r-d/sanofi-regeneron-post-more-positive-dupilumab-data-as-pdufa-date-for-eczema-blockbuster-waiting Sanofi and Regeneron have taken a deeper dive into phase 3 data on hotly tipped atopic dermatitis drug dupilumab. The fresh results further burnish the credentials of an asset that is up for review at FDA this month. Mar 6, 2017 3:43am Nick Paul Taylor https://www.fiercebiotech.com/52afa16c-dcc5-4748-8f93-c71c051f4107 https://www.fiercebiotech.com/r-d/karyopharm-aml-drug-fails-phase-2-giving-stock-whiplash A phase 2 trial of Karyopharm’s selinexor in patients with acute myeloid leukemia (AML) has been deemed destined to fail during an interim analysis. The failure wiped 15% of Karyopharm’s stock price after hours, eradicating most of the gains it made earlier in the day. Mar 3, 2017 4:30am Nick Paul Taylor https://www.fiercebiotech.com/67489f5f-9459-44f8-9228-a1a799526de6 https://www.fiercebiotech.com/r-d/novartis-chairman-google-smart-lens-a-high-risk-project Novartis Chairman Joerg Reinhardt is talking down the chances of the smart contact lens project it began with Google yielding anything incredible in the next four years. Describing the program as highly risky, Reinhardt reframed a collaboration that was once seen yielding a commercial product by 2019 as a long-term long shot. Mar 2, 2017 9:39am Nick Paul Taylor https://www.fiercebiotech.com/23c3c524-f4c6-43de-8f09-23881bf50b22 https://www.fiercebiotech.com/r-d/juno-ditches-lead-car-t-program-following-patient-deaths Juno Therapeutics has halted development of its lead CAR-T therapy months after patient deaths hindered the odds of success. The decision sees Juno switch its focus to JCAR017, a follow-up program that uses a defined CD4-CD8 composition company execs thinks will improve safety and efficacy. Mar 2, 2017 4:08am Nick Paul Taylor https://www.fiercebiotech.com/7102ebaf-8c2c-47cf-9f8d-3c1880ad6449 https://www.fiercebiotech.com/r-d/accera-fails-phase-3-alzheimer-s-trial-denting-energy-theory A phase 3 trial of Accera’s Alzheimer’s disease candidate has missed its primary endpoint. The trial aimed to show Accera’s brain metabolism-focused approach to improving outcomes in Alzheimer’s could succeed where beta-amyloid drugs have failed, but instead ended up becoming yet another late-phase failure. Mar 1, 2017 3:19am Nick Paul Taylor https://www.fiercebiotech.com/82d2dcfb-46e0-4b68-8c98-c92f2ac46175 https://www.fiercebiotech.com/r-d/kite-6-month-car-t-data-show-sustained-efficacy-boosting-prospects-ahead-upcoming-fda-filing Kite Pharma’s pioneering CAR-T has shown sustained efficacy over six months. The latest data drop from the pivotal trial of patients with aggressive non-Hodgkin lymphoma shows most of the responses seen at three months persisted, diminishing concerns about the durability of response in the run-up to a filing for FDA approval. Feb 28, 2017 8:31am Nick Paul Taylor https://www.fiercebiotech.com/a92de0ff-a3de-455f-8059-0fde53445e7e https://www.fiercebiotech.com/r-d/roche-starts-second-alzheimer-s-phase-3-anti-abeta-drug Roche is doubling down on its anti-amyloid beta antibody crenezumab. The Swiss Big Pharma is starting a second phase 3 trial in patients with prodromal to mild Alzheimer’s disease after getting a look at binding, dose escalation and drug-disease progression model data late last year. Feb 28, 2017 6:24am Nick Paul Taylor https://www.fiercebiotech.com/fbbf6878-2dd0-4fac-8585-19233a1a1c79 https://www.fiercebiotech.com/r-d/patient-death-phase-3-raises-doubts-about-safety-roche-s-potential-hemophilia-blockbuster Roche has revealed that a patient died in a phase 3 hemophilia trial of bispecific antibody emicizumab. The trial investigator ruled the death was unrelated to emicizumab, but, with the event following on from other reports of similar serious adverse reactions, it has added to questions about the safety of the experimental regimen. Feb 24, 2017 4:39am Nick Paul Taylor https://www.fiercebiotech.com/3446edb0-2150-4092-bbdc-ef8b865ef31f https://www.fiercebiotech.com/r-d/after-merck-kgaa-rejection-apitope-advances-ms-drug-strength-phase-2a-safety-lesion-reduction Apitope has posted phase 2a data on the multiple sclerosis drug Merck KGaA walked away from last year. The single-arm study linked immunotolerizing peptide-based candidate ATX-MS-1467 to a drop in total and new neurological lesions, giving Apitope the confidence to forge ahead with plans to run a phase 2b trial. Feb 22, 2017 7:45am Nick Paul Taylor https://www.fiercebiotech.com/65ff1e56-77b9-4559-9afb-467990933495 https://www.fiercebiotech.com/biotech/trial-shows-armagen-biologic-improves-cognition-hurler-syndrome-patients The biotech's CEO says the clinical trial is the first to show that it is possible to usher large-molecule drugs across the blood-brain barrier. Feb 17, 2017 8:11am Phil Taylor https://www.fiercebiotech.com/d84bc80b-daf1-4232-b2bd-416a0e730381 https://www.fiercebiotech.com/r-d/takeda-tigenix-stem-cell-therapy-shows-sustained-effect Takeda and TiGenix have presented 52-week data on their allogeneic expanded adipose-derived stem cells in Crohn’s disease patients with treatment-refractory complex perianal fistulas. The data show the Cx601 stem cells continue to outperform placebo one year after administration. Feb 17, 2017 4:24am Nick Paul Taylor https://www.fiercebiotech.com/05e0d1c5-371f-496b-af4a-37e6cb81238f https://www.fiercebiotech.com/r-d/uniqure-details-three-pronged-gene-therapy-trial-program uniQure plots to initiate a three-pronged clinical trial program next year as key assets from its in-house pipeline and Bristol-Myers Squibb collaboration advance. uniQure aims to move its hemophilia B gene therapy, AMT-060, into a pivotal trial while working to advance a Huntington's disease asset and Bristol-Myers-partnered heart failure candidate into the clinic. Feb 16, 2017 6:44am Nick Paul Taylor https://www.fiercebiotech.com/3d5063fe-a4db-4c3d-8870-50eb07ac1fcb https://www.fiercebiotech.com/r-d/roche-steps-to-help-fund-34m-lumos-round-for-rare-disease-r-d Lumos Pharma spent much of its $14 million A round on laying the preclinical/IND foundation for its lead rare disease program. And now the Austin-based company has $34 million more to mount a clinical stage program over the next two years that could blaze a path directly to an NDA. Apr 7, 2016 9:10am John Carroll https://www.fiercebiotech.com/d733c1a6-c61c-4798-9fd7-9e1008d20d4b https://www.fiercebiotech.com/r-d/bind-therapeutics-looks-for-big-immuno-oncology-partner-as-ceo-mulls-selling-company As Bind Therapeutics announced a major cut to its workforce yesterday after a set of mixed results for its lead cancer candidate, its CEO tellsFierceBiotechthat the company will need a major backer to push Bind-014's lung cancer trials forward--and he may be forced to sell the company. Apr 7, 2016 8:47am Ben Adams https://www.fiercebiotech.com/040d3e83-0352-46f7-869b-353c6efde995