Coronavirus Update: Moderna And Pfizer Respond To Vaccine Trial Transparency Demands
Striving to be transparent with the public about the development of their COVID-19 vaccine, Pfizer Inc. and Moderna, Inc. have both released the study ..... see more
Source : 'Scrip Intelligence'
Dr Reddy’s To Steer Russian COVID-19 Vaccine Plans In India
Major Indian pharma firm Dr. Reddy's Laboratories Ltd. is venturing into the COVID-19 vaccines arena, agreeing to co-operate with the Russian Direct Investment Fund (RDIF) on clinical trials and ..... see more
Source : 'Scrip Intelligence'
Pfizer's COVID-19 Vaccine Commercialization Plan Includes DTC Campaign
In a sign of how quickly Pfizer Inc.'s COVID-19 vaccine is moving towards commercialization, Biopharmaceuticals group president Angela Hwang outlined some of early launch plans for the vaccine ..... see more
Source : 'Scrip Intelligence'
EMA Endorses Use Of Dexamethasone In COVID-19
The European Medicines Agency’s drug evaluation committee, the CHMP, has given an opinion endorsing the use of dexamethasone as a treatment option for hospitalized COVID-19 patients who require oxygen therapy. ..... see more
Source : 'The Pink Sheet'
Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Senior writers Derrick Gingery and Sarah Karlin-Smith and Executive Editor Nielsen Hobbs look at Novavax, Inc.’s unexpected problems finding a manufacturing facility for its seasonal influenza vaccine candidate, ..... see more
Source : 'The Pink Sheet'
Virtual Advisory Committees: US FDA Clears A Big Test With OxyContin Meeting
At the conclusion of a US Food & Drug Administration advisory committee’s two-day review of “real world” data gauging the impact of Purdue Pharma L.P.’s reformulation of OxyContin ..... see more
Source : 'The Pink Sheet'
US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process
Despite the coronavirus pandemic’s inspection hiatus, the US Food and Drug Administration’s field organization, the Office of Regulatory Affairs, has been able to make judgments on the quality of hundreds ..... see more
Source : 'The Pink Sheet'
World First Or Beating The US? China Ups COVID-19 Vaccines Game
Claiming that it will soon launch domestically the first vaccines against a virus still wreaking havoc globally, China is poised to take on the US in producing probably the ultimate ..... see more
Source : 'The Pink Sheet'
Human Factors Experts Forge Ahead With ‘Tricky’ In-Person Studies In The Age Of Coronavirus
Not long ago, in the time before COVID-19, human factors professionals at Sanofi went about their day-to-day routines with a minimum of concern, conducting in-person “summative” testing of products – ..... see more
Source : Medtech Insight
India’s Saptagir Partners With Jubilant On Remdesivir
India’s Saptagir Laboratories has announced an exclusive agreement with Jubilant Generics to manufacture intermediates and active pharmaceutical ingredients for remdesivir at its local good manufacturing practice-certified manufacturing plant at Hyderabad.Shilpa ..... see more
Source : 'Generics Bulletin'
COVID-19 Vaccines: US Distribution Plans Include ‘Data Lake’ For Centralized Tracking
The US government’s COVID-19 vaccination strategy includes tracking distribution and administration through a data exchange system that will help ensure timely administration of a second dose ..... see more
Source : 'The Pink Sheet'
Preventing Missing Data Among US FDA Concerns In Outpatient COVID-19 Symptom Assessment Guidance
Researchers should keep close tabs on clinical trial participants completing outpatient patient-reported outcome measurements in order to avoid missing data, the US Food and Drug Administration says.New see more
Source : 'The Pink Sheet'
Taskforce On Telehealth Policy Releases Final Recommendations On Safeguarding Virtual Care Beyond Pandemic
The Taskforce on Telehealth Policy released a final report on 15 September outlining findings and recommendations on safeguarding the future of telehealth beyond the COVID-19 pandemic. ..... see more
Source : Medtech Insight
Interview: Data And Connected Insight In Arthroplasty Will Take Corin Beyond COVID
The two-decade journey of Corin Orthopaedics Holdings Limited through the orthopedics market, changing its portfolio and being taken into private equity, latterly under the ownership of Permira, has been ..... see more
Source : Medtech Insight
Coronavirus Notebook: EU Invests In Convalescent Plasma, ACT-Accelerator Wants More Vaccines
If you thought COVID-19 convalescent plasma was yesterday’s news, think again. Results from studies of the treatment may have been disappointing so far, but the European Commission believes there is ..... see more
Source : 'The Pink Sheet'
New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says
Sponsors interested in developing vaccines for COVID-19 should accelerate the process by using their existing vaccine manufacturing platforms, according to Peter Marks, director of the US Food and Drug Administration’s ..... see more
Source : 'The Pink Sheet'