J&J

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…

The state of the fight: 

South Africa’s Biovac will fill-finish the Pfizer/BioNTech vaccine.
  The U.S. will give $200 million to South Africa’s Aspen Pharmacare to boost vaccine capacity.
  CEPI and IVI are backing new vaccine trials in Africa.

 

Regulatory updates

Sanofi’s “Vidprevtyn” under rolling review: The EMA announced Tuesday it has begun reviewing the recombinant protein Covid-19 vaccine candidate, which uses a GSK adjuvant. Sanofi also expects real…

J&J will pay up to $5 billion over nine years under a settlement over its role in the U.S. opioid epidemic, media reported Tuesday. The agreement with U.S. states, cities and counties will also cost three U.S. drug distributors a combined $21 billion, according to The Washington Post.

J&J said in a press release that the settlement is designed to resolve “the vast majority of litigation-based claims” over its opioid sales.

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J&J

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…

J&J last week launched a research center hosted at the London School of Hygiene & Tropical Medicine (LSHTM) that will focus on antimicrobial resistance (AMR) and next-generation TB drug regimens. The J&J Satellite Center for Global Health Discovery at LSHTM marks the first in a planned series of academic research centers, according to a company press release.

Each center will partner with academic institutions to focus on threats with high unmet need, including AMR,…

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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: 

Gavi plans new terms and conditions for self-financing COVAX participants.
  Cuba’s three-dose Abdala vaccine candidate proved 92.3% effective in Phase 3.
  The U.S. halted distribution of two monoclonal antibodies from Eli Lilly.

 

Approved or authorized vaccines

Bharat Biotech submitted final Phase 3 data to Indian regulators showing 77.8% efficacy for its Covaxin vaccine, local media reported Tuesday.
 
In other news on…

The state of the hunt: 

The vaccine candidate from Novavax demonstrated 90.4% overall efficacy in Phase 3—and 93% against “key variants.”
  CureVac’s mRNA vaccine candidate performed poorly, missing the primary endpoint in a Phase 3 trial riddled with variant infections.
  The U.S. launched a $3 billion program to stimulate antiviral drug R&D. Approved or authorized vaccines

European regulators over the past week gave mixed signals on the safety profile of…

The state of the hunt: 

China authorized Sinovac’s vaccine for children as young as age 3.
  The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
  Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.   Approved or authorized vaccines

China cleared Sinovac’s CoronaVac jab for youths ages 3 to 17, becoming the first country to offer Covid-19 vaccines to…

Johnson & Johnson published on Wednesday its annual environmental, social and governance (ESG) performance report. The 2020 Health for Humanity Report highlighted the company’s Covid-19 response, global health strategy, responsible business practices, and reporting frameworks and standards.

On global health, J&J touted approvals of its Ebola vaccine and long-acting rilpivirine-containing injectable HIV treatment regimen and the company’s commitment of $50 million to support…