Hetero

The state of the hunt:

The United Kingdom issued emergency authorization of Pfizer/BioNTech’s vaccine.
  WHO is reviewing the Pfizer/BioNTech shot for Emergency Use Listing.
  Moderna requested emergency nods for its mRNA-based vaccine from the U.S. FDA and the European Medicines Agency.

 

Vaccines


Approved or authorized vaccines

Pfizer is now seeking full British marketing authorization for its Covid-19 vaccine “in parallel” with the…

The state of the hunt:

With their mRNA vaccine showing an interim efficacy rate above 90%, Pfizer and BioNTech may have the necessary data to apply for U.S. FDA Emergency Use Authorization this month.
  Eli Lilly snagged the first FDA EUA for an anti-SARS-CoV-2 monoclonal antibody.
  Indonesia and Morocco laid out plans for Covid-19 mass immunization campaigns before year-end.

 

Vaccines


Phase 3 candidates:

Pfizer/BioNTech’s shot more…

The state of the hunt:

Novavax brought its vaccine candidate to Phase 2.
  WHO reportedly offered wealthier countries new, more flexible terms for the COVAX Facility.
  The U.S. FDA expanded the Emergency Use Authorization for Gilead’s Veklury (remdesivir).

 

Vaccines

Phase 3 candidates:
 
Pfizer and BioNTech have enrolled more than half of the 30,000 people they seek for U.S.-based Phase 3 trials of their mRNA Covid-19 vaccine candidate,…

The state of the hunt:

Gilead says remdesivir showed 62% reduced mortality in severe patients
  Sinovac received approval to commence Phase 3 vaccine studies in Brazil
  Pfizer CEO hopes for October FDA vaccine approval
  Hep C drugs sofosbuvir and daclatasvir showed “provocative and encouraging” results against Covid-19

 

Vaccines

Clinical trials:

Brazil regulators approved a Phase 3 trial of Beijing-based Sinovac’s inactivated vaccine…

The state of the hunt:

China sent another inactivated candidate to Phase 2—its fourth vaccine of that type to move beyond Phase 1 trials.
  CEPI has identified manufacturing capacity for 4 billion vaccine doses.
  The WHO-led Access to COVID-19 Tools (ACT) Accelerator is seeking almost $28 billion in additional funds.

 

Vaccines

Clinical trials:

Another Chinese candidate in Phase 2: An inactivated vaccine from the Chinese Academy of Medical…

Gilead announced voluntary licenses yesterday with five generic manufacturers for its Covid-19 therapeutic, remdesivir, following up on a week-old pledge. The companies will set their own prices for the drug in as many as 127 countries, a list that includes “nearly all” low- and lower-middle-income countries, according to a Gilead press release.

The manufacturers—India’s Cipla, Hetero Labs and Jubilant Life Sciences; Pakistan’s Ferozsons Laboratories; and the United States’ Mylan—can…

Hetero announced this week that the Drug Controller General of India has approved its fixed-dose combination of emtricitabine and tenofovir alafenamide TAFERO-EM, the first generic version of Gilead’s HIV antiretroviral, Descovy.

Mentions:

Hetero Drugs announced this week that the Drugs Controller General of India has approved its generic version of Gilead’s Epclusa, for the treatment of patients with chronic hepatitis C. The Sofosbuvir/Velpatsavir combination treatment will be marketed as Velasof in India and was devaeloped under a 2014 non-exclusive licensing agreement with Gilead that increases access to hepatitis C medicines in developing countries.

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