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
Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East The […]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
The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score […]Read More
The FDA approval is based on P-III study results assessing Xywav vs PBO in 201 patients to evaluate the safety and efficacy in the treatment of cataplexy and EDS in patients with narcolepsy The study resulted in statistically significant differences in weekly number of cataplexy attack and Epworth Sleepiness Scale scores Xywav, also known as […]Read More
Shots: The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval Inqovi is a novel […]Read More
Shots: The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul 01, 2020. Additionally, the early results of German trial evaluating BNT162b1 are expected in Jul 2020 The companies BNT162 mRNA-based vaccine program involves the evaluation of 4 investigational candidates developed to target […]Read More
The approval is based on P-III trial assessing Upneeq vs PBO in 2:1 ratio in 140 patients with acquired blepharoptosis split into two treatment groups for 42 days. Additionally, another second P-III clinical trial evaluated safety and efficacy of Upneeq vs PBO in 35 patients to treat acquired blepharoptosis The study resulted in well tolerated […]Read More
Shots: Abbott’s Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) are developed for heart rhythm disorders including patient-preferred design without compromising battery longevity and MRI compatibility also allows Bluetooth connectivity on the smartphones for improved remote monitoring, increased patient/physician engagement and streamlined communications The Gallant pairs with Abbott’s secure myMerlinPulse for streamline communication […]Read More
Shots: The US FDA has granted Emergency Use Authorization (EUA) for its rapid point-of-care BD Veritor SARS-CoV-2 Assay which allows the result in 15 mins evaluated in 20 sites across the US with 84% sensitivity and 100% specificity. Additionally, BD plans for increasing capacity to produce 2M tests per week by the end of September […]Read More
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