Research & Evidence

Real-World Evidence Shows Pfizer’s Ibrance Improves Breast Cancer

by Samantha McGrail

Pfizer recently presented real-world evidence demonstrating a significant benefit for patients treated with Ibrance (palbociclib) combined with an aromatase inhibitor (AI) compared to AI...

Gilead, Dragonfly to Advance Immunotherapies in Oncology

by Samantha McGrail

Gilead and Dragonfly Therapeutics recently collaborated to advance several of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation...

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...

AstraZeneca to Open Drug Research, Development Site in MA

by Samantha McGrail

AstraZeneca recently announced plans to open a new drug research and development site at the heart of Cambridge, MA, for itself and Alexion’s new corporate headquarters. The strategic center...

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 AstraZeneca BLA for Hepatocellular Carcinoma Antibody

by Samantha McGrail

FDA recently accepted AstraZeneca’s biologics license application (BLA) for its anti-CTLA4 antibody, tremelimumab, supporting the indication of a single primary dose of the drug added to Imfinzi...

Pfizer Reports Positive Phase 2 Data for Lyme Disease Vaccine

by Samantha McGrail

Pfizer and Valneva recently reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 that enrolled...

Sandoz Launches Generic Drug Combination for Ocular Hypertension

by Samantha McGrail

Sandoz recently launched its generic drug combination eyedrop, brimonidine tartrate/ timolol maleate ophthalmic solution 0.2%/0.5%, to lower eye pressure in patients with ocular...

J&J Launches Satellite Center to Tackle Antimicrobial Resistance

by Samantha McGrail

Johnson & Johnson recently launched the J&J Satellite Center for Global Health Discovery (Satellite Center) to tackle the present and the rising threat of antimicrobial resistance (AMR) with a...

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...

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,...

Sanofi Launches First-in-Pharma Diversity, Equity, Inclusion Board

by Samantha McGrail

Sanofi recently launched its first-in-pharma Diversity, Equity, & Inclusion (DE&I) Board to encourage an inclusive and diverse culture that enables breakthrough innovations.   The...

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...

Sandoz Expands Collaboration in Antimicrobial Resistance Fight

by Samantha McGrail

Sandoz recently expanded its strategic collaboration agreement with Ares Genetics (Ares) to drive cutting-edge digital solutions in the global fight against antimicrobial resistance (AMR).  The...

New Toolkit Supports Digital Endpoints in Drug Development

by Samantha McGrail

The Digital Medicine Society (DiMe), Anthem, Biogen, Eli Lilly & Company, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op recently launched a toolkit of resources to support organizations...

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...