GSK

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…

GSK used its second-quarter 2021 results, released Wednesday, to announce the abandonment of a Phase 2 pediatric RSV vaccine candidate after results showed the shot (GSK3389245A/ChAd155-RSV) was unlikely to meet target efficacy. The company also has adult and maternal immunization candidates for RSV in Phase 3.

Nonetheless, the U.S. FDA did hand GSK a good start to the week: on Monday, the agency expanded the market for Shingrix, approving the blockbuster shot for the prevention of…

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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…

GSK’s board defended the company’s performance last week in response to an open letter from activist investor Elliott Advisors complaining that “GSK has failed to capture business opportunities due to years of under-management.”

A company press release said major progress has been achieved to “improve performance, strengthen R&D productivity, enhance commercial execution, and to streamline GSK’s portfolio and cost base.” The board also pointed to “significant changes in culture and…

Amid pressure from activist investors, GSK on Wednesday offered details on longstanding plans to “demerge” its consumer healthcare arm into a separately listed company. Set for mid-2022, the spinoff will include a one-time dividend paid to the parent entity—restyled as a growth-focused drugs and vaccines behemoth dubbed “New GSK”—of up to $11.2 billion.

Flush with funds, New GSK will concentrate on R&D and commercial investments across four core therapeutic areas (infectious…

GSK subsidiary ViiV will pay Halozyme Therapeutics $40 million upfront (plus milestones) for rights to develop HIV medicines with dosing intervals of three months or longer using Halozyme’s rapid drug delivery technology, the companies announced jointly on Tuesday.

According to the press release, ViiV plans to launch trials in 2021 with its drug cabotegravir, which is currently administered every two months for prevention of HIV.

The state of the hunt: 

WHO cleared Sinovac’s vaccine for emergency use.
  Gavi’s COVAX AMC funding summit exceeded its goals, securing $2.4 billion in commitments.
  India ordered 300 million doses of a yet-to-be-authorized Bio E vaccine candidate. Approved or authorized vaccines

Sinovac’s inactivated vaccine notched WHO Emergency Use Listing on Monday, leaving the shot, CoronaVac, eligible for supply through the COVAX Facility. Less-demanding storage requirements…

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 tri-antigenic hepatitis B shot from VBI Vaccines showed either non-inferiority (in people age 18 or older) or superiority (in people age 45 and older) to GSK’s single-antigen Engerix-B in Phase 3 findings published Tuesday in The Lancet Infectious Diseases.

The results—which improve on prior studies—give a boost to the Massachusetts-based company as it positions Sci-B-Vac to compete with GSK’s more established product.

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