Sanofi

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

The state of the fight: 

Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
  Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
  Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full licensure, the companies announced Friday.
 
While the press release noted a…

Corporate restructuring, clinical trial results, and a new business investment kept Sanofi in the news this week.

First, the company announced Monday that as part of its “ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory,” it will offload 16 products to Germany’s STADA Arzneimittel. Neither firm disclosed deal terms.

The same day, Sanofi announced that its respiratory syncytial virus (RSV) single-dose monoclonal…

Sanofi and Massachusetts-based Translate Bio have launched a Phase 1 trial of an mRNA-based seasonal flu vaccine candidate targeting influenza A/H3N2, the companies announced Tuesday. The study will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in up to 280 healthy adults, per the press release. The collaborators also have a Covid-19 vaccine candidate in Phase 1/2 and plan to develop mRNA shots for up to three additional pathogens.

In other Sanofi news, a new…

The state of the hunt: 

Moderna’s vaccine showed high efficacy in adolescents.
  U.S. regulators cleared a monoclonal antibody from GSK and Vir for emergency use.
  Sanofi and GSK launched the Phase 3 trial of their vaccine candidate.   Approved or authorized vaccines

Moderna touts data for teens: Less than two months after Pfizer and BioNTech boasted of their mRNA-based jab’s 100% efficacy in adolescents, Moderna shared almost identical news. The Massachusetts-…

Takeda released three-year Phase 3 follow-up results for its tetravalent dengue vaccine last week—reporting 83.6% efficacy in preventing hospitalization and 62% efficacy against the disease overall, per its press release.

The company found no important safety risks and observed no evidence of disease enhancement in dengue-naïve participants, according to the press release. Sanofi’s Dengvaxia was discontinued by the Philippine government in 2017 after the company warned the shot could…

The state of the hunt:

J&J, Moderna and Pfizer/BioNTech pledged to provide 3.5 billion vaccine doses to LMICs at low cost.
  Sanofi touted favorable interim Phase 2 results for its protein-based vaccine candidate.
  Serum Institute of India pushed back its timeline to resume exporting vaccine doses to COVAX.

 

Approved or authorized vaccines

 
India’s review of bleeding and clotting events following immunization found a minuscule risk of those…

New Delhi-based Panacea Biotec has filed a patent infringement suit against Sanofi in an Indian court, per local media, reportedly seeking to block the multinational from launching a hexavalent vaccine in the country that would compete with Panacea’s EasySix. Sanofi disputed Panacea’s patent in 2017, the Times of India said.

Serum Institute of India, a minority shareholder of Panacea, supplies IPV for EasySix and holds co-marketing rights for the shot.

Mentions:

Twelve leading pharma companies released first-quarter 2021 financial results in April. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, Abbott’s first-quarter worldwide sales jumped 32.9% over last year’s to $10.5 billion, missing consensus estimates by 3.5%. Its diagnostics business continued to boom, with strong Covid-19 test sales driving 115% growth. The company said it has delivered nearly 700 million Covid-19 tests since the start of the…

The state of the hunt:

Moderna’s mRNA-based vaccine secured Emergency Use Listing from WHO.
  Merck entered voluntary licensing agreements with five Indian drugmakers for its investigational antiviral molnupiravir.
  Biological E’s subunit vaccine candidate advanced to Phase 3.

 

Vaccines


Approved or authorized vaccines
    
WHO granted Moderna’s vaccine Emergency Use Listing on Friday, according to a press release from the…