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 Global Health Technologies Coalition 


R&D News Roundup: September 6, 2022


Top News in R&D

"Game-changer" Paxlovid turns into pandemic enigma
Axios (9/2)
Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.

'Beginning of the end': Patients hail new treatment for drug-resistant TB
France24 (8/31), features TB Alliance
A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.
Additional coverage from TB Alliance (8/31), CIDRAP (9/1), and Health Policy Watch (9/1)

Pfizer and Moderna's updated COVID boosters win FDA nods, with swift rollouts to follow
Fierce Pharma (8/31)
On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks.
Additional coverage from Reuters (8/31), NPR (8/31), and Health Policy Watch (8/31)



News from GHTC

Breaking: DNDi Founder Bernard Pécoul steps down After 19 years
Health Policy Watch (9/5), features Drugs for Neglected Diseases initiative (DNDi)

Sponsored content: Neglect this silent pandemic at your peril
Politico (9/2), features Boston University's Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and Global Antibiotic Research and Development Partnership

PREVAIL begins clinical research on Lassa fever study vaccine
Liberian Observer (9/1), features IAVI and Coalition for Epidemic Preparedness Innovations (CEPI)
Additional coverage in IAVI press release (8/31) and CEPI press release (8/31)

Avails Medical awarded additional $1.7M in CARB-X funding
360Dx (9/1), features CARB-X

First-line HIV treatment proves mettle in pregnant patients
MedPage Today (9/1), features Elizabeth Glaser Pediatric AIDS Foundation

Opinion: Vaccines aren’t enough – therapeutic drugs can help save more lives in the next pandemic
The Telegraph (8/31), features CEPI and Bill & Melinda Gates Foundation

The polio threat continues to grow—but a new vaccine could make a difference
Time (8/31), features Gates Foundation

S.Africa's Aspen, India's Serum Institute sign vaccines deal for Africa
Reuters (8/31), features CEPI and Gates Foundation

Opinion: Political leaders need to invest in global research and development to prepare for next pandemic
Health Policy Watch (8/30), features CEPI

Japan reiterates commitment to HIV vaccine development with a $10.5 million contribution to IAVI
IAVI press release (8/29), features Global Health Innovative Technology Fund and CEPI

Perspective: Leveraging lessons learned from the COVID-19 pandemic for HIV
Nature (8/29), by International Vaccine Institute



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