Gilead

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

Gilead, Merck and the TB Alliance were among the players touting new data at the 11th International AIDS Society Conference on HIV Science (IAS 2021), held in a virtual format July 18-21.

Gilead on Saturday offered promising Phase 2/3 news on lenacapavir, its investigational, long-acting HIV-1 capsid inhibitor, which it said achieved “high rates of virologic suppression” at week 26 in people living with HIV whose virus was no longer effectively responding to therapy. A company press…

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…

The Drugs for Neglected Diseases Initiative (DNDI) announced Monday that Malaysia has become the first country to grant conditional registration to ravidasvir as part of a two-drug treatment for adults with chronic hepatitis C. The collaborators plan to sell the treatment—combining the antiviral, licensed from Presidio Pharmaceuticals to DNDI and Egypt’s Pharco Pharmaceuticals, with a Pharco-produced version of Gilead’s sofosbuvir—at an “affordable” price (between $300 and $500 for a 12-week…

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:

WHO issued Emergency Use Listing for the inactivated vaccine from CNBG’s Beijing subsidiary.
  Pfizer and BioNTech applied for full U.S. FDA approval of their Comirnaty vaccine.
  Moderna and Novavax inked supply deals with COVAX for at least 850 million combined doses.

 

Vaccines


Approved or authorized vaccines
   
WHO listed the BBIBP-CorV vaccine from CNBG’s Beijing subsidiary for emergency use on Friday,…

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…

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…

The state of the hunt:

A subcutaneous dose of Regeneron’s REGEN-COV mAb reduced the risk of symptomatic Covid-19 by 81% among household contacts of people with the disease.
  South Africa and the United States suspended their rollouts of J&J’s vaccine on safety concerns.
  The EMA committee reviewing safety signals in J&J’s vaccine will announce a conclusion on Tuesday, while a U.S. CDC committee reviewing the shot won’t meet again until Friday, April 23.

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