Fujifilm

Fujifilm announced Tuesday it is putting approximately $850 million in cash into its CDMO arm, Fujifilm Diosynth Biotechnologies, to boost biologics capacity in Britain and the United States—joining a multibillion-dollar CDMO investment spree among companies worldwide.

In the U.S., the investment will double cell culture production for recombinant vaccines. Across the Atlantic, the money will triple cell culture capacity (and will include cGMP capacity for continuous manufacturing),…

The state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…

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…

Massachusetts-based Thermo Fisher announced last week its $877 million all-cash acquisition of Novasep’s Belgian viral vector manufacturing business, Henogen. The purchase will help Thermo Fisher “expand its capabilities for cell and gene vaccines and therapies globally,” the press release said.

Fellow CDMO Fujifilm Diosynth Biotechnologies also has new manufacturing muscle in the works. Fujifilm and its collaborator, the Massachusetts Center for Advanced Biological Innovation and…

Fujifilm will boost its U.S. manufacturing capacity through two investments in CDMO subsidiary Fujifilm Diosynth Biotechnologies, the Japanese company announced last week.

First, in a $2 billion project, Fujifilm plans a new large-scale cell culture production facility, located “in the vicinity of an existing Fujifilm site,” that will provide end-to-end, single-site drug production capabilities.

Fujifilm will also invest $40 million to establish a new process development and…

The state of the hunt:

The Pfizer/BioNTech vaccine received several new authorizations, including from the European Union.
  Canada joined the U.S. in authorizing Moderna’s jab. .
  Argentina and Belarus became the first countries outside Russia to OK Sputnik V.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech will market their BNT162b2 vaccine in the European Union under the brand name Comirnaty after receiving…

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…

The state of the hunt:

CEPI expanded its funding for Clover Biopharmaceuticals’ S-Trimer Covid-19 vaccine candidate to $328 million.
  Humanigen touted positive interim Phase 3 results for lenzilumab and announced a cooperative R&D deal with the U.S. government.
  Russia approved a domestic version of Fujifilm’s Avigan for coronavirus outpatients, dubbing the product “the first [f]avipiravir-based drug in the world approved for the treatment of COVID-19.”

 

The state of the hunt:

The U.S. FDA approved Gilead’s Veklury (remdesivir) for hospitalized Covid-19 patients 12 and older.
  IAVI, Merck and Serum Institute of India will collaborate to develop anti-SARS-CoV-2 monoclonal antibodies they plan to make accessible to LMICs.
  AstraZeneca resumed U.S. Phase 3 trials of its AZD1222 Covid-19 vaccine candidate.

 

Vaccines

Phase 3 candidates:
 
J&J is “preparing to resume recruitment” for the…

The state of the hunt:

Regulators in Brazil, Canada and Europe commenced accelerated “rolling reviews” of AstraZeneca’s vaccine candidate even as the U.S. FDA widened its probe of the shot amid safety concerns.
  Serum Institute of India doubled its commitment of affordable Covid-19 vaccine doses to the COVAX AMC, pledging up to 200 million.
  The ACT Accelerator launched a partnership to provide 120 million Covid-19 rapid antigen tests to LMICs over six months.

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