Zydus Cadila

The state of the fight: 

South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.
  Afrigen also secured a $45 million grant from the U.N.-backed Medicines Patent Pool.
  Moderna’s Spikevax notched full approval in the U.S.

REGULATORY UPDATES

 
Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…

The state of the fight: 

Moderna and Pfizer/BioNTech launched trials of Omicron-specific vaccine candidates.
  India fully approved SII’s Covishield and Bharat Biotech’s Covaxin shots.
  CEPI tapped BioNet to develop a “variant-proof” pan-coronavirus mRNA-based vaccine.

AUTHORIZED VACCINES  

New data on rates of myocarditis following mRNA-based vaccination trickled in this week, highlighting an increased risk of the heart inflammation side effect in young men…

The U.S. FDA has awarded Orphan Drug Designation to Zydus Cadila’s malaria therapeutic, the company announced last week.

The status gives the Ahmedabad-based drugmaker eligibility for “certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval,” the press release said.

Zydus Cadila is developing the potential single-dose ZY19489 (MMV253) radical cure for P.…

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …

The state of the fight: 

More European countries cautioned against Moderna’s vaccine for younger people over concerns about side effects.
  Generics companies are preparing to roll out their versions of Merck’s molnupiravir oral antiviral.
  Pfizer is in talks with 90 countries over supply deals for its antiviral candidate.

 

AUTHORIZED VACCINES  


France and Germany recommended against the Moderna vaccine for people under 30 over concerns about…

The state of the fight: 

Zydus Cadila’s three-dose, needle-free ZyCoV-D became the first authorized DNA-based Covid-19 vaccine.
  AstraZeneca’s AZD7442 long-acting antibody reduced infection risk by 77% in Phase 3.
  PAHO’s Revolving Fund will begin procuring Covid-19 vaccines for member states. Approved or authorized vaccines

 
Assessing antibody levels to predict Moderna’s effectiveness: Researchers at Seattle’s Fred Hutchinson Cancer Research Center announced…

The state of the hunt: 

India authorized Moderna’s shot.
  Zydus Cadila applied for authorization in India of its DNA-based vaccine, which proved 67% effective in Phase 3.
  Five Indian generics manufacturers will conduct a joint trial of Merck’s molnupiravir antiviral.


Editor’s note: The Covid-19 R&D round-up will be on hiatus next week. Please look for our next issue on Friday, July 16.

 

Approved or authorized vaccines

Iran granted…

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-…

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…

The state of the hunt:

European, South African and U.S. regulators cleared J&J’s single-dose vaccine for resumed use.
  Pfizer/BioNTech’s vaccine showed 85% effectiveness against any infection—symptomatic or not—in a 23,000-participant British study of health workers, published in The Lancet.
  India authorized a Zydus Cadila hepatitis therapy for emergency use against Covid-19.

 

Vaccines


Approved or authorized vaccines
   
A U.S…