Skip to main content
micro-community-banner
 
  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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'

  • Saved

made a Post

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

  • Saved

made a Post

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

  • Saved

made a Post

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'

  • Saved

made a Post

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'