Clinical Trials

Pfizer to Acquire BioPharma Company to Develop RSV Therapeutics

by Samantha McGrail

Pfizer will acquire clinical-stage biopharmaceutical company ReViral to discover, develop, and commercialize novel antiviral respiratory syncytial virus (RSV) therapeutics.   ReViral’s...

FDA Approves ViiV Healthcare’s HIV-1 Treatment for Children

by Samantha McGrail

FDA recently approved ViiV Healthcare’s fixed-dose combination of abacavir, dolutegravir, and lamivudine to treat pediatric patients with HIV-1.    The agency also approved 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...

FDA Expands Indication of Long-Acting Injectable HIV Treatment

by Samantha McGrail

FDA recently expanded the indication of the long-acting injectable HIV regimen, Cabenuva, to include virologically suppressed adolescents 12 years of age and older.  Johnson & Johnson and...

AstraZeneca to Share New Data on Oncology Treatment Landscape

by Samantha McGrail

AstraZeneca recently announced that it will present new data underscoring its oncology treatment landscape through diverse early pipelines and novel drug combinations.  The company’s next...

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 Approves Second Dose of Moderna’s COVID-19 Vaccine

by Samantha McGrail

FDA recently amended the emergency use authorization of Moderna's COVID-19 vaccine to allow for a second booster dose at the 50 microgram level in adults 50 years of age and older.  The...

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...

Vivalink’s Biometrics Data Platform Monitors Oncology Patients

by Samantha McGrail

Digital healthcare solutions company, Vivalink, will provide its Biometric Data Platform to help detect neutropenic fever events in oncology patients.   Vivalink is at the forefront 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...

Keytruda Boosts Survival Rate for Non-Small Cell Lung Cancer

by Samantha McGrail

Merck and the European Thoracic Oncology Platform (ETOP) recently announced that Keytruda significantly improved disease-free survival (DFS) in patients with stage IB to IIA non-small cell lung cancer...

Boehringer Ingelheim Halts Chronic Kidney Disease Trial

by Samantha McGrail

Boehringer Ingelheim recently announced that the Phase 3 clinical trial studying empagliflozin in adults with chronic kidney disease (CKD) will stop early based on a recommendation from the trial's...

Moderna Doses First Patient in HIV mRNA Vaccine Clinical Trial

by Samantha McGrail

Moderna recently dosed the first participant in an HIV trimer mRNA vaccine (mRNA-1574) clinical trial.   The open-label Phase 1 trial will evaluate the safety and immunogenicity of...

Pfizer’s C. Difficile Vaccine Misses Primary Endpoint in Trial

by Samantha McGrail

Pfizer recently announced that a Clostridioides difficile (C. difficile) vaccine candidate did not meet its primary endpoint of C. difficile infection (CDI) prevention, but was 100- percent effective...

Pfizer Initiates Phase 2/3 Clinical Trial of COVID-19 Treatment

by Samantha McGrail

Pfizer recently initiated a Phase 2/3 clinical trial to evaluate the safety, pharmacokinetics, and efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, symptomatic pediatric...

FDA Approves Boehringer Ingelheim’s Heart Failure Treatment

by Samantha McGrail

FDA recently approved Boehringer Ingelheim's Jardiance to reduce the risk of cardiovascular death and hospitalization in heart failure in adults. The agency based its approval on the safety and...

Gilead’s Trodelvy Helps HR/HER2 Metastatic Breast Cancer Patients

by Samantha McGrail

Gilead recently announced that the Phase 3 clinical trial of Trodelvy in patients with HR/HER2-metastatic breast cancer met its primary endpoint. The Phase 3 TROPiCS-02 study evaluated Trodelvy versus...

FDA Issues 3 Cancer Clinical Trial Final Guidance Documents

by Samantha McGrail

FDA recently issued three final guidance documents to the industry regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and rebuild upon his 2016 Cancer...