News

The Padcev/Keytruda combination produced statistically significant and clinically meaningful improvements to survival compared to platinum-containing chemotherapy in first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

In an interview with ACT editor Andy Studna, Jim Reilly, VP, R&D Strategy, Veeva Systems, discusses ways stakeholders can select the best solutions available in clinical trials.

Recent study tests the ability of machine learning to effectively classify patient safety event reports.

The FDA has cleared an investigational new drug application and granted Fast Track designation to ACDN-01, the only clinical-stage therapeutic targeting the genetic cause of Stargardt disease.

Phase II TRANSCEND FL and Phase I TRANSCEND NHL 001 trial data lead to FDA Priority Review designation for Breyanzi to treat relapsed or refractory follicular lymphoma and mantle cell lymphoma.

Intravenous immunoglobulin Gammagard Liquid approved by the FDA to treat neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.

The pursuit of balance between data utility, privacy protection, and equitable representation.

Monthly, higher doses of novel therapy SRP-5051 (vesleteplirsen) found to produce substantially greater increases in dystrophin and exon skipping compared to the lower weekly dose.

Trial shows Keytruda improved overall survival by 38% compared with placebo in in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and resection of metastatic lesions.

The Priority Revew designation was based on findings from the ongoing, global, multicenter, multi-cohort, open-label Phase II DESTINY-PanTumor02 trial of of Enhertu for patients with previously treated HER2-expressing tumors, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and other tumor types.

In an interview with ACT editor, Andy Studna, Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) discusses the Summit for Clinical Ops Executives (SCOPE) conferences in Europe and the US.

By promoting the use of a standardized terminology and coding system, IDMP eliminates inconsistencies in regulatory processes.

A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.

Testing in humans in clinical trials and the regulatory approval process itself are candidates for technology solutions where artificial intelligence is playing a role.

Approval based on findings from the Phase III EoE KIDS trial, in which 66% of patients administered a higher dose of Dupixent based on weight achieved histological disease remission.

Zynrelef was the first dual-acting local anesthetic approved by the FDA with a fixed-dose combination of bupivacaine and meloxicam.

Theratechnologies said it will address the concerns raised in the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients with HIV.

Survey of over 100 industry professionals measured opinions on future research within the therapeutic area of obesity treatment.

Tremfya achieved the co-primary endpoints of Scalp-Specific Investigator Global Assessment score of 0/1 and Psoriasis Scalp Severity Index 90 response at week 16 in the trial.

The FDA made the decision to require boxed warnings on CAR T-cell therapies based on reports of T-cell malignancies in patients administered BCMA- or CD19-directed autologous CAR T-cell immunotherapies.

FDA accepts biologics license application from Autolus Therapeutics for obecabtagene autoleucel to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

Conducted by Onward Therapeutics, the trial will evaluate a bispecific antibody generated from Biomunex’s BiXAb platform.

Mirati’s oncology portfolio includes promising early phase clinical assets such as a potential first-in-class MTA-cooperative PRMT5 inhibitor and a leading KRAS and KRAS enabling program with a pair of candidates in Phase I development.

Data from prior Phase II study showed signs of pridopidine slowing disease progression in patients with amyotrophic lateral sclerosis.

NK010 is a non-genetically modified natural killer cell therapy that dislayed significant potential in inhibiting strong tumor growth on ovarian cancers in animal studies.

Osteoboost was previously granted FDA Breakthrough Device Designation to treat diminished bone health in postmenopausal women with osteopenia.

Satri-cel (satricabtagene autoleucel) showed a promising safety and efficacy profile in patients with gastric or gastroesophageal cancer and pancreatic cancer.

Opdivo (nivolumab) with Yervoy (ipilimumab) improved progression-free survival in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

In clinical trials, Cimerli met FDA standards for biosimilarity to the reference Lucentis, including safety, efficacy, and quality.

Balversa (erdafitinib) is a fibroblast growth factor inhibitor granted accelerated approval by the FDA in April 2019 for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.