Patient Outcomes

Pfizer’s COVID-19 Treatment Reduces Disease by 37% Post-Exposure

by Samantha McGrail

Pfizer recently announced that its COVID-19 treatment, Paxlovid reduced disease by 32% and 37% in adults for 5–10 days, respectively, compared to placebo.   The Phase 2/3 EPIC-PEP study...

Bristol Myers Ends Clinical Program for Combination Drug Therapy

by Samantha McGrail

Bristol Myers Squibb and Nektar Therapeutics recently ended the global clinical development program for their combination drug therapy, bempegaldesleukin (BEMPEG) and Opdivo (nivolumab), in renal cell...

Novartis’ Antibody Boosts Survival for Squamous Cell Carcinoma

by Samantha McGrail

Novartis recently announced that its IgG4 anti-PD-1 monoclonal antibody, tislelizumab, plus chemotherapy, significantly improved overall survival (OS) compared to chemotherapy in  esophageal...

Eli Lilly’s Obesity Drug Elicits 22.5% of Weight Loss in Adults

by Samantha McGrail

Eli Lilly and Company recently announced that patients in a Phase 3 trial who received its obesity drug, tirzepatide, lost up to 22.5% of their body weight.   The SURMOUNT-1 clinical trial...

Roche’s Drug Improves Infants with Type 1 Spinal Muscular Atrophy

by Samantha McGrail

Roche recently announced new three-year data of its study evaluating Evrysdi (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA).   The FIREFISH study evaluated the...

FDA Approves AstraZeneca’s Drug for Generalized Myasthenia Gravis

by Samantha McGrail

FDA recently approved AstraZeneca’s Ultomiris to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The agency based the...

FDA Expands Approval of COVID-19 Treatment, Remdesivir

by Samantha McGrail

FDA recently expanded the approval for COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older weighing at least seven pounds.  The agency's decision...

FDA Accepts Application for GSK’s Chronic Kidney Disease Drug

by Samantha McGrail

FDA recently accepted the New Drug Application (NDA) for GSK’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia of chronic kidney...

FDA Grants Priority Review for Non-Small Cell Lung Cancer Drug

by Samantha McGrail

The FDA recently granted priority review for AstraZeneca's Enhertu to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and...

Sanofi’s BTK Inhibitor Effective in Immune Thrombocytopenia Patients

by Samantha McGrail

Sanofi recently announced positive results from the Phase 1/2 clinical trial evaluating its Bruton's tyrosine kinase (BTK) inhibitor, rilzabrutinib, in adults with heavily pre-treated immune...

Moderna Doses Participants in Study of Two Influenza mRNA Vaccines

by Samantha McGrail

Moderna recently dosed the first patients in a Phase 1/2 study of its influenza mRNA vaccine candidates, mRNA-1020 and mRNA-1030.  The randomized, observer-blind trial will evaluate the safety,...

WHO Recommends Johnson & Johnson’s COVID-19 Vaccine for Booster Use

by Samantha McGrail

The World Health Organization (WHO) recently updated the emergency use listing (EUL) for Johnson & Johnson’s COVID-19 vaccine, recommending it as a booster in individuals 18 years of age and...

Eli Lilly’s Retevmo Helps Non-Small Cell Lung Cancer Patients

by Samantha McGrail

Eli Lilly & Company recently announced updates on the Phase 2 clinical trial studying its kinase inhibitor, Retevmo, in RET fusion-positive non-small cell lung cancer (NSCLC).  The...

Roche’s Small Cell Lung Cancer Antibody Fails in Phase 3 Trial

by Samantha McGrail

Roche recently announced that its monoclonal IgG1 antibody, tiragolumab, plus Tecentriq and chemotherapy, did not meet its co-primary endpoints in a Phase 3 extensive-stage small cell lung cancer...

Merck’s CMV Drug Lowers Reactivation by 88% After Cell Transplant

by Samantha McGrail

Merck recently announced that its cytomegalovirus (CMV) treatment, Prevymis (letermovir), lowered the odds of CMV reactivation by 88% 100 days after allogeneic hematopoietic cell transplantation...

Pfizer’s S1P Modulator Drug Helps Ulcerative Colitis Patients

by Samantha McGrail

Pfizer recently announced positive top-line results from a second Phase 3 study of its selective sphingosine 1-phosphate (S1P) receptor modulator, etrasimod, to treat moderately to severely active...

FDA Declines Eli Lilly’s Letter for Non-Small Cell Lung Cancer Drug

by Samantha McGrail

FDA recently issued a complete response letter (CRL) for Eli Lilly and Company’s biologics license application (BLA) for its combination antibody therapy, sintilimab, to treat nonsquamous...

FDA Approves Bristol Myers Antibody Combination for Melanoma

by Samantha McGrail

FDA recently approved Bristol Myers Squibb’s antibody combination, Opdualag (nivolumab and relatimab-rmbw), for adult and pediatric patients 12 years of age and older with unresectable or...

Pfizer’s Ulcerative Colitis Drug Helps Patients in Phase 3 Study

by Samantha McGrail

Pfizer recently announced that its selective sphingosine 1-phosphate (S1P) receptor modulator to treat moderate to severely active ulcerative colitis (UC) significantly improved the primary endpoint of...

Pfizer Submits for EUA of Additional COVID-19 Vaccine Booster

by Samantha McGrail

Pfizer and BioNTech recently submitted an application to FDA for emergency use authorization (EUA) of an additional COVID-19 vaccine booster dose for adults 65 years and older.   The...