Data presented at the European Hematology Association Congress indicated that patients with chronic lymphocytic leukemia treated with Imbrivica had a significantly longer median progression-free survival compared to patients treated with chlorambucil.
Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.
In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses data presented at ASCO from ABBV-400 and ABBV-706 in multiple studies.
Investigators followed a group of people born from 1990-1996 to assess whether the association between preterm birth and income differs according to family socioeconomic status at birth.
The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample.
Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics.
Klisyri is now available in a 350 mg package size as a topical treatment for actinic keratosis on the face or scalp.
Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.
Survodutide is the first glucagon/GLP-1 receptor dual agonist to show a high level of benefit in treating liver fibrosis associated with metabolic dysfunction-associated steatohepatitis.
Approval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.
According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.
Data published in the New England Journal of Medicine from Gilead’s Phase IIb MYR204 found the bulevirtide/ pegylated interferon alfa-2a combination was more effective in achieving undetectable HDV RNA compared to bulevirtide 10 mg monotherapy in the treatment of chronic hepatitis D.
Acquisition of Elsie Biotechnologies is expected to strengthen GSK’s research capabilities in modulating gene expression through the use of oligonucleotide.
A similar application was also submitted to the EMA for the expanded use of Prezcobix to treat children aged 6 years and older with HIV.
In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder.
Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma.
After three years of study, the V940 and Keytruda combination demonstrated sustained benefits in recurrence-free survival and distant metastasis-free survival in patients with high-risk melanoma following complete resection.
Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.
Results of the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status.
Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.
In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's VelociSuite technology.
Approval of Onyda XR marks the first liquid non-stimulant medication for attention-deficit hyperactivity disorder to hit the market in the United States.
Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer.
Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Priority Review status for inavolisib is based on positive Phase III data showing the inavolisib-based regimen significantly extended progression-free survival in patients with hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks key findings from the ongoing phase I/II trial of linvoseltamab in multiple myeloma that led to the submission of an FDA Biologics License Application (BLA).
The acquisition of a novel therapy for atopic dermatitis includes an all-cash transaction totaling approximately $1.25 billion.
Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation.
Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders.
