Gilead

The state of the fight: 

Moderna shared new Phase 2/3 data supporting the use of Spikevax in children under age 6.
  Pfizer will supply UNICEF with up to 4 million Paxlovid courses in 2022.
  Boosters of mRNA vaccines continued to offer strong protection against severe Covid-19 outcomes.   AUTHORIZED VACCINES

 
Moderna claimed clinical trial success for its vaccine in children ages 6 months to under 6 years. An interim analysis of Phase 2/3 results showed a “…

The state of the fight: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children ages…

Fourteen leading pharma companies released fourth-quarter and full-year 2021 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the pack, SK Bioscience generated an unprecedented $375 million in fourth-quarter revenues—a 573% jump from the same period in 2020—driven by its CMO drug substance manufacturing business, which contributed to AstraZeneca/Oxford and Novavax Covid-19 vaccine production. The South Korean company also…

The state of the fight: 

Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
  Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
  Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.   AUTHORIZED VACCINES

 
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine to…

Gilead last week offered new clinical data on the sustained efficacy of lenacapavir in heavily treatment-experienced people living with multidrug-resistant HIV. At 52 weeks, 83% of participants receiving the investigational, long-acting HIV-1 capsid inhibitor (in combination with an optimized background regimen) achieved an undetectable viral load, according to the California-based company's press release. Gilead presented the data at the 29th Conference on Retroviruses and Opportunistic…

The state of the fight: 

Moderna applied for South African patents on its vaccine, potentially jeopardizing the work of the WHO-led mRNA vaccine “hub” operating in the country.
  WHO named five additional African countries that will receive vaccine technology from the hub.
  Laboratorios Farmacéuticos Rovi inked a 10-year mRNA vaccine manufacturing extension with Moderna.   AUTHORIZED VACCINES

                                       
Medigen’s protein subunit…

The state of the fight: 

A Lilly mAb active against Omicron won a U.S. FDA emergency use nod.
  Novavax’s shot proved 80% efficacious in adolescents ages 12-17, according to a Phase 3 readout.
  Vaxxinity’s UB-612 vaccine candidate performed better against Omicron than an mRNA-based comparator jab.

 

AUTHORIZED VACCINES

 
J&J’s single-dose shot was only 53% efficacious against moderate to severe Covid-19 (28 days post-injection) in a final analysis…

Gilead will pay rival ViiV $1.25 billion upfront and a 3% royalty on future U.S. sales (through 2027) of its once-daily single-tablet Biktarvy regimen—bictegravir, emtricitabine and tenofovir alafenamide—as part of a patent infringement settlement, ViiV’s parent company announced Monday.

The GSK subsidiary filed suit against Gilead in 2018, claiming that the bictegravir component of Biktarvy infringed on ViiV’s patents relating to its dolutegravir HIV drug and other compounds.

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 state of the fight: 

African vaccine production advanced on multiple fronts, including the opening of a new manufacturing plant in South Africa.
  The COVAX AMC seeks an additional $5.2 billion this year.
  Merck will supply UNICEF with up to 3 million courses of molnupiravir in the first half of 2022.

AUTHORIZED VACCINES  

The Chilean health ministry released data on the Sinovac jab’s effectiveness in children. In kids ages 6-11, the topline numbers…