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How Moderna is Taking on the Pharma Giants With its COVID-19 Vaccine

  • Post author:Sam
  • Post published:November 19, 2020
  • Post category:Drug Industry Daily

As some of the world’s largest drugmakers gear up to manufacture and distribute COVID-19 vaccines, a relatively tiny competitor, Massachusetts-based Moderna, faces some unique challenges. Source: Drug Industry Daily

Continue ReadingHow Moderna is Taking on the Pharma Giants With its COVID-19 Vaccine

Agios Withdraws European Tibsovo AML Submission

  • Post author:Sam
  • Post published:October 20, 2020
  • Post category:Drug Industry Daily

Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring…

Continue ReadingAgios Withdraws European Tibsovo AML Submission

Endo Gains Control of Two Collagenase Therapies in BioSpecifics Purchase

  • Post author:Sam
  • Post published:October 20, 2020
  • Post category:Drug Industry Daily

Endo International announced that it will purchase the biopharmaceutical company BioSpecifics Technologies for approximately $540 million giving the company complete control over two promising collagenase-based therapies. Source: Drug Industry Daily

Continue ReadingEndo Gains Control of Two Collagenase Therapies in BioSpecifics Purchase

UK Authorizes COVID-19 Human Challenge Trial

  • Post author:Sam
  • Post published:October 20, 2020
  • Post category:Drug Industry Daily

The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Source: Drug…

Continue ReadingUK Authorizes COVID-19 Human Challenge Trial

Sinopharm to Supply 1 Billion COVID-19 Vaccine Doses Next Year

  • Post author:Sam
  • Post published:October 20, 2020
  • Post category:Drug Industry Daily

China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021. Source: Drug Industry Daily

Continue ReadingSinopharm to Supply 1 Billion COVID-19 Vaccine Doses Next Year

Moderna Could Earn EUA for COVID-19 Vaccine in December, CEO Says

  • Post author:Sam
  • Post published:October 20, 2020
  • Post category:Drug Industry Daily

Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected…

Continue ReadingModerna Could Earn EUA for COVID-19 Vaccine in December, CEO Says

FDA Cites Nutravail for Data Integrity, Supplier Validation

  • Post author:Sam
  • Post published:October 19, 2020
  • Post category:Drug Industry Daily

Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Source:…

Continue ReadingFDA Cites Nutravail for Data Integrity, Supplier Validation

Administration to Finalize Rule to Allow Drug Imports From Canada

  • Post author:Sam
  • Post published:September 20, 2020
  • Post category:Drug Industry Daily

Despite industry resistance and reluctance from state legislatures, the Trump administration is gearing up to issue a final rule allowing states to import prescription drugs from Canada as part of…

Continue ReadingAdministration to Finalize Rule to Allow Drug Imports From Canada

Merck’s Keytruda Improves Survival for Esophageal Cancer Patients

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category:Drug Industry Daily

Merck said its blockbuster cancer drug Keytruda (pembrolizumab) in combination with chemotherapy significantly improved survival in patients with locally advanced or first-line metastatic esophageal cancer in a phase 3 clinical…

Continue ReadingMerck’s Keytruda Improves Survival for Esophageal Cancer Patients

Pfizer-BioNTech COVID-19 Vaccine Moves Into Pivotal Trial

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category:Drug Industry Daily

Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial. Source: Drug Industry…

Continue ReadingPfizer-BioNTech COVID-19 Vaccine Moves Into Pivotal Trial
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