For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.
MOMA Therapeutics and Eli Lilly are both experiencing significant changes in their leadership roster, with one Takeda alum taking the helm at MOMA and an R&D chief at Lilly shooting toward the exit door.
Concert Pharmaceuticals said its Phase II clinical trial for its adjunctive schizophrenia treatment, CTP-692, did not meet the primary endpoint or other secondary endpoints, causing the company to halt development of the drug.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).
A research team from Brigham and Women’s Hospital has discovered an astrocyte sub-population that serves an anti-inflammatory function in the brain based on signals regulated by gut bacteria.
The Series A financing will help fuel Nuvalent’s research and development efforts for a portfolio of innovative small molecule kinase inhibitors for programs in non-small cell lung cancer.
Pfizer announced in a statement on Wednesday that the prespecified non-inferiority criteria for a post-marketing safety study of rheumatoid arthritis (RA) drug XELJANZ® (tofacitinib) were not met.
Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.
Moderna announced it has started development on a booster to its COVID-19 vaccine, which the company hopes will work against the recently discovered (and more transmissible) SARS-CoV-2 variant from South Africa.
A study from researchers at Monash University in Melbourne has identified two molecules in the gut microbiome that can protect against asthma and may possibly reduce the severity of an asthma attack.
Despite the rising number of COVID-19 cases reported across the globe, rates of influenza have virtually flatlined across the Northern Hemisphere, leading many doctors and researchers to wonder how this could be replicated in non-pandemic times.
Northway Biotech, which was previously Northway Biotechpharma, has opened a new $40 million 30,000-square-foot process development and Current Good Manufacturing Practice (cGMP) manufacturing site in Waltham, Mass.
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
The decision was made based on an Independent Data Monitoring Committee recommendation which indicated the study was unlikely to meet its specified primary efficacy endpoint of progression-free survival.
