Tags : ViiV Healthcare

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More

Insights+: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, […]Read More

Insights+: COVID-19 Healthcare News Monthly Updates

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More

PharmaShots Weekly Snapshot (March 09-13, 2020)

1. I-Mab to Initiate the Development of TJM2 for Treating Cytokine Release Syndrome Associated with COVID-19 Published: Mar 13, 2020 | Tags: I-Mab, Initiate, Development, TJM2, Treating, Cytokine Release Syndrome, COVID-19 2. EMD Serono and Pfizer to Terminate P-III JAVELIN Head and Neck 100 Study Evaluating Bavencio + CRT for Squamous Cell Carcinoma of the Head […]Read More

PharmaShots Weekly Snapshot (January 13-17, 2020)

1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, FDA, Fast Track Designation, Treat, Patients, Decompensated Heart 2. Charles River Collaborates with Fios Genomics for Bioinformatics-Driven Drug Discovery and Safety Assessment Published: Jan 16, 2020 | Tags: Charles River, Collaborates, Fios Genomics, […]Read More

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives MHLW’s Approval to Treat HIV

Shots: The approval is based on GEMINI 1 & 2 studies assessing dual drug regimen (dolutegravir 50 mg/lamivudine 300 mg) vs dolutegravir + two NRTIs [tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)] in 1400 patients with HIV-1 infection aged> 12yrs. weighing at least 40kg  The GEMINI 1 & 2 study results demonstrated non-inferior efficacy based on plasma HIV-1 […]Read More

PharmaShots Weekly Snapshot (December 09-13, 2019)

1.  Pfizer’s Amsparity (biosimilar, adalimumab) Receives CHMP’s Positive Opinion for Inflammatory and Autoimmune Disorders Published: Dec 12, 2019 | Tags: Pfizer, Amsparity, biosimilar, adalimumab, Receives, CHMP, Positive Opinion, Inflammatory, Autoimmune Disorders 2.  Janssen’s Darzalex (daratumumab) Combination Regimen Receives CHMP’s Positive Opinion for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Published: Dec 13, 2019 | […]Read More