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 Global Health Technologies Coalition 


R&D News Roundup: November 21, 2022


Top News in R&D

Moderna says new booster increases protection from omicron subvariants
The Washington Post (11/14)
Additional coverage from the Wall Street Journal (11/14)

Last week, Moderna announced that its new booster shot targeted at the omicron subvariant of COVID-19 raises immune protection against subvariants by increasing levels of omicron-blocking antibodies up to 15 times pre-booster levels. Moderna also said that an early analysis showed that while the antibodies generated by the booster were less effective against the rapidly growing BQ.1.1 subvariant, they could still block it. This announcement follows similar positive findings that were released by Pfizer and BioNTech earlier this month about their own bivalent coronavirus vaccine booster. However, Novavax also recently released results showing that their bivalent booster did not show a stronger response than their original booster.

Shorter regimen for resistant TB could save $740 million a year
CIDRAP (11/17)

Last week, an analysis done by researchers from TB Alliance, Stop TB Partnership, and the World Health Organization estimated that the BPaLM/BPaL treatment regimen for drug-resistant tuberculosis (DR-TB) could save governments up to US$740 million a year. Implementation of the all-oral, shorter regimen is estimated to be 40 to 90 percent less expensive than current drug regimens for DR-TB, when accounting for drug costs, healthcare costs, and patient-incurred costs. The cost savings from the new regimen coupled with the shorter time period and the fewer drugs that are easier to tolerate, BPaLM/BPaL could contribute to more people with DR-TB having access to treatment and improved treatment experiences.

WHO, Uganda plan to test three candidate Ebola vaccines in outbreak
STAT (11/16), features IAVI, Sabin Vaccine Institute, and Johnson & Johnson

Last week, the World Health Organization (WHO) announced that WHO and the Ugandan government are planning to test three candidate Ebola vaccines in a clinical trial with the intent to help address the ongoing outbreak in the country. The first doses are expected to arrive this week, although it is unclear when exactly the trial will start. The vaccines being used in the trial include one produced by IAVI, one developed by the Sabin Vaccine Institute, and a final developed by the Jenner institute at the University of Oxford. While there have been questions about the usefulness of the trial if it concludes after the outbreak ends, the results of the trials could provide essential information that will help prevent future Sudan Ebolavirus outbreaks even if it concludes after the current outbreak. Additionally, the trial design will enable all participants to receive a vaccine (though some will receive it after a delay) as opposed to a standard randomized controlled trial in which one group gets a placebo.



News from GHTC

GARDP begins study in South Africa focusing on the increasing rate of antibiotic-resistant infections in hospitals
Global Antibiotic Research and Development Partnership (GARDP) (11/21)

First-of-its-kind license agreement forges path to expand antibiotic access in low- and middle-income countries
World Intellectual Property Organization guest post (11/21), guest-authored by GARDP, Shionogi, and CHAI

Inovio drops Lassa, MERS vaccines as clinical data fall short, gutting infectious disease pipeline
Fierce Biotech (11/18), features the Coalition for Epidemic Preparedness Innovations

Factbox: Vaccines and drugs in the pipeline for RSV
Reuters (11/18), features Johnson & Johnson

Is the first malaria vaccine worth the cost?
Devex (11/17), features PATH and the Bill & Melinda Gates Foundation

Response to tuberculosis treatment trials results published and presented during the 2022 Union World Conference on Lung Health
Treaatment Action Group (TAG) statement (11/16)

After decades of setbacks, scientists make strides toward the holy grail of male birth control
STAT (11/16), features Population Council

Report: Pharma firms must boost access for LMICs, R&D for pandemic threats
CIDRAP (11/15), features Johnson & Johnson



Highlights From the Week

mRNA drugs with a built-in ‘copy machine’ could lead to safer, more effective therapies
STAT (11/18)

Pandemic treaty ‘zero-draft’ makes a strong case for regional production
Health Policy Watch (11/17)
Additional coverage from Reuters (11/18)

The HPV vaccine market is changing. But there are other access threats
Devex (11/17)

COVID pandemic led to surge in superbug infections, EU agency says
Reuters (11/17)

Delays in global, affordable access to long-acting, injectable HIV medicines would cost lives, say AIDS campaigners
UNAIDS news release (11/16)

Covid-19 vaccines were a success, but mRNA still has a delivery problem. Two startups have an unorthodox solution
STAT (11/16)

Opinion: Political leaders must act now to thwart the next pandemic
Scientific American (11/15)

Industry pushes FDA for tailored complex generics post-approval changes guidance
Regulatory Focus (11/15)

ICMR seeks proposals for manufacture of antimicrobial resistance diagnostics kits
Mint (11/15)

PharmaJet inks deal to use needle-free delivery tech in polio vaccination campaign
Fierce Pharma (11/15)

GSK's antibiotics strategy scores 2nd win this month with phase 2 TB data
Fierce Biotech (11/15)

Perfection is too high a bar for CRISPR treatments, says STAT Biomedical Innovation Award winner David Liu
STAT (11/15)

Opinion: The $6 billion shot at making new antibiotics—before the old ones fail
WIRED (11/14)

Invasive mosquito threatens malaria control in Africa
Voice of America (11/14)



COVID-19 R&D spotlight



Monkeypox R&D Spotlight

US FDA authorizes Roche's monkeypox test
Reuters (11/15)
Additional coverage from 360Dx (11/15)



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