News

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.

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.

A discussion of where cell and gene therapies are currently doing, what's on the horizon, personalization, and much more.

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.

With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value.

Data from the NETTER-2 trial show that first-line treatment with Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with advanced gastroenteropancreatic neuroendocrine tumors.

The Phase III LUNAR trial (NCT02973789) is evaluating the addition of tumor-treating fields to standard-of-care therapies in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.

In an interview with ACT editor, Andy Studna, Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) discusses what ClinEco is and how the need to create it came about.

Natural language processing models are able to automate the extraction of pertinent information from a vast array of scientific literature.

FDA Fast Track Designation precedes an acceleration of enrollment in a Phase I trial of NX-5948 in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.

Utility Therapeutics’ pivmecillinam is an oral antibiotic for the treatment of uncomplicated urinary tract infections.

New machine learning technology combines artificial intelligence with automated experiments.

Findings from ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials lead to FDA approval for HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.