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
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
Shots: The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA […]Read More
Shots: The approval is based on ongoing P1093 (NCT03016533) and ODYSSEY (PENTA20, NCT02259127) studies in pediatric patients aged 4 weeks to 18 years, while the second study involves 2L pediatric patients aged four weeks to 18 years The P1093 study was conducted by IMPAACT network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and […]Read More
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
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
Shots: ViiV Healthcare has renewed its research agreement with UNC-Chapel Hill to the tune of ~$20M over five years for solely focus on the discovery of therapies for HIV The scientists from both the companies will work at the HIV Cure Center, which was created in 2015 at the start of the collaboration. The public-private […]Read More
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
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
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
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