Shionogi

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced Tuesday that it has signed a memorandum of understanding (MOU) with the Clinton Health Access Initiative (CHAI) and Shionogi to accelerate LMIC access to the Osaka-based drugmaker’s antibiotic cefiderocol (Fetroja).

The collaboration will help introduce the drug—indicated for bacterial infections in patients with limited treatment options—into health systems and provide clinical guidance to…

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca/Oxford’s…

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced last week that it has signed a memorandum of understanding with India’s Dr. Reddy’s and Aurigene Pharmaceutical Services to explore joint opportunities to make novel drug-resistant gonorrhea treatment zoliflodacin “accessible in low- and middle-income countries (LMICs), including South Africa, Thailand and India.”

The press release did not detail deal terms outside of GARDP’s responsibility to…

The state of the hunt:

Moderna’s became the second Covid-19 vaccine to receive U.S. FDA Emergency Use Authorization.
  COVAX has secured nearly 2 billion doses of vaccines but faces a “very high” failure risk, according to Reuters.
  Canada, Saudi Arabia and the United States have begun immunization campaigns using Pfizer/BioNTech’s jab.

 

Vaccines


Approved or authorized vaccines
 
The U.S. FDA granted Emergency Use Authorization (EUA…

Osaka-based drugmaker Shionogi announced Tuesday the publication of two studies in The Lancet Infectious Diseases highlighting the efficacy and safety of cefiderocol (Fetroja) for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options.

While Pharma Letter said the results were a boost for Shionogi’s newly EC-approved antibiotic, Endpoints News (referencing a review of the Lancet research) said cefiderocol was only “as good as” the…

The state of the hunt:

The EU is reportedly weighing abstention from the COVAX Facility due to vaccine pricing and timing concerns.
  An inhaled interferon drug produced extraordinary Phase 2 data in a study some critics have faulted.
  Vaccines from AstraZeneca-Oxford University, CanSino, and Pfizer-BioNTech had positive Phase 1/2 or Phase 2 news.

 

Vaccines

Clinical trials:

The Lancet published preliminary Phase 1/2 results Monday showing the…

Roche and its Japan-based collaborator Shionogi chalked up another success this week when The Lancet Infectious Diseases published favorable results from a 2018 Phase 3 trial comparing their novel influenza treatment Xofluza (baloxavir marboxil) with Roche’s now off-patent Tamiflu (oseltamivir).

The Shionogi-funded study found that a single Xofluza dose was as effective as 10 doses of Tamiflu taken over five days. Generic competition has heavily eroded former blockbuster Tamiflu’s…

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The state of the hunt: 

Gilead’s remdesivir became the first Covid-19 therapeutic to score Emergency Use Authorization from the U.S. FDA. Inovio, J&J, Moderna and Oxford University have signed new deals with manufacturing partners for their vaccine candidates. The inactivated vaccine from CNBG’s Wuhan subsidiary has entered Phase 2, with its ongoing Phase 1 trial showing “good safety” to date.

 

Vaccines

Our Covid-19 Vaccine Dashboard provides comprehensive…

The U.S. FDA announced this week that it has approved Roche’s Xofluza (baloxavir marboxil) single-dose tablet to treat influenza in people 12 years of age and older who have been symptomatic for less than 48 hours. This is the first time in nearly 20 years that the U.S. FDA has approved an antiviral flu treatment with a new mechanism of action.

Japan fast-tracked approval of the drug for Shionogi in February.

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Results published in this week’s New England Journal of Medicine showed that the new one-dose influenza tablet from Roche and Japan’s Shionogi, baloxavir marboxil, shortened symptoms by one day in Phase 2 and Phase 3 trials compared to a placebo and reduced viral load compared to Roche’s Tamiflu.

Japanese regulators fast-tracked the novel treatment’s approval in February, while the U.S. FDA granted a priority review to the drug in June.

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