Gilead

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

On the final day of last week’s annual Conference on Retroviruses and Opportunistic Infections (CROI), Spanish biotech Aelix Therapeutics touted positive topline results from the first-in-human Phase 1/2a trial of its investigational HTI T cell therapeutic vaccine in early-treated people living with HIV.

The AELIX-002 trial evaluated people who interrupted their antiretroviral treatment (ART) after vaccine administration. In a subset of participants who had “a favourable genetic…

Mentions:

Gilead and Merck announced on Monday a deal to co-develop and market long-acting HIV treatments combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s nucleoside reverse transcriptase translocation inhibitor candidate, islatravir.

According to the press release, Gilead and Merck will share costs at a ratio of 60% and 40%, respectively, and lead commercialization efforts in different geographies depending on the product formulation.

Mentions:

The state of the hunt:

J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
  A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
  Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization or death in people with mild or moderate Covid-19 at high risk of progression…

Merck, Gilead and ViiV captured headlines for their HIV portfolios at this week’s annual Conference on Retroviruses and Opportunistic Infections (CROI).

First, Merck announced on Monday that a reformulated version of its islatravir NRTTI subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP) may provide protection for “at least one year,” based on Phase 1 data. A company researcher told NAM Aidsmap that planned Phase 2 trials of the new version will be “very similar” to the Phase…

Mentions:

Twelve leading pharma companies released fourth-quarter and full-year 2020 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, Gilead’s fourth-quarter revenue soared 26% over last year to $7.4 billion, beating consensus estimates by 4%. Veklury (remdesivir) drove the surge with $1.9 billion in quarterly sales: the antiviral now treats one in two hospitalized Covid-19 patients in the United States, according to the…

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:

Two versions of the AstraZeneca/Oxford vaccine secured EUL from the World Health Organization.
  J&J has applied for both WHO and EMA authorization for Janssen’s Covid-19 vaccine.
  The Pfizer/BioNTech shot remains stable at higher temperatures than previously believed.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech are testing their vaccine in pregnant women through a 4,000-participant…