The Pandemic Antiviral Discovery (PAD) initiative has launched with up to $90 million in coordinated funding from the Gates Foundation, the Novo Nordisk Foundation and San Francisco’s Open Philanthropy, the three organizations announced Monday.

PAD aims to support development of Phase 2-ready, orally delivered, small-molecule drug candidates targeting pandemic threat viruses (including coronaviruses, paramyxoviruses and…

Serum Institute of India (SII) will pursue an mRNA vaccine against shingles under a tie-up with Boston-based GreenLight Biosciences, the companies announced Monday. Under the agreement, GreenLight “will work to discover and design” a shingles jab and up to two other products for SII to develop, manufacture and commercialize in emerging markets in Africa, parts of Asia, Latin America and the Middle East, per a joint press release. GreenLight…

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) has dosed the first participant in a Phase 1 trial of a trio of mRNA-based vaccines against HIV, according to a press release Monday from the U.S. National Institutes of Health.

Manufactured by Moderna through a NIAID-backed contract, each of the three candidates in the mRNA-1574 vaccine program encodes for “different but highly related, stabilized proteins” of HIV,…

Mentions: Moderna, NIAID, HIV, vaccines

The state of the fight: 

  • Moderna pledged permanently to forgo enforcement of its Covid-19 vaccine patents for shots made “in or for” 92 LMICs.
     
  • Aspen Pharmacare will market an Aspen-branded version of J&J’s vaccine in Africa.
     
  • Fluvoxamine reduced the risk of Covid-19 hospitalization and clinical deterioration by 31% in a meta-analysis.
  BOOSTERS

 
A WHO technical…

The Coalition for Epidemic Preparedness Innovations locked up over $1.5 billion this week as countries, NGOs and other donors made commitments at the Global Pandemic Preparedness Summit in London.

Pledged funds will back CEPI’s $3.5 billion plan to boost global R&D and manufacturing over the next five years and “compress vaccine development timelines to 100 days,” according to CEPI’s Tuesday press release.

A synthetic biology-based diagnostic using a low-cost portable reader matched the sensitivity and specificity of real-time quantitative PCR tests for Zika and chikungunya, according to research published Monday in Nature Biomedical Engineering.

The cell-free, paper-based test uses a “field-ready” companion device called PLUM (Portable, Low-cost, User-friendly, Multimode), according to a press release from the University of Toronto,…

Moderna on Monday unveiled a sweeping global health strategy that includes an mRNA manufacturing facility in Kenya, an expanded pledge not to enforce patents on its Covid-19 shot in certain countries, and a portfolio of 15 vaccine programs targeting emerging or neglected infectious diseases. But the company also made clear it would pursue these objectives on its own terms, brushing aside activist demands that it share intellectual property…

Neutralizing antibody titers produced by Valneva’s live attenuated, single-dose chikungunya vaccine candidate (VLA1553) held up in over 96% of trial participants after six months, the company announced Tuesday, citing a final analysis of Phase 3 data.

Seroprotection levels at the one-month mark confirmed topline data the French biotech shared in 2021: the Coalition for Epidemic Preparedness Innovations-backed shot generated neutralizing…

When ViiV Healthcare announced last week that it would not pursue a voluntary licensing deal for its long-acting HIV prevention shot, blowback was swift. Advocacy groups cried foul. STAT remarked on the “surprise move.” The company backpedaled within days, but its updated statement continued to indicate the GSK subsidiary would remain the sole supplier of long-acting cabotegravir, “at least during the initial years.”

The statement that…

Newly revealed data have called into question last year’s exuberant claims from AstraZeneca and Sanofi about nirsevimab, their single-dose monoclonal antibody (mAb) to prevent RSV in infants, Endpoints News reported last week. Published in the New England Journal of Medicine, the Phase 3 data showed that the mAb’s effects on hospitalization were not statistically significant.

Hospitalization is a “key metric” for the potentially…

The state of the fight: 

  • Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
     
  • South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
     
  • Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.
  AUTHORIZED VACCINES

 

Viatris will offload its biosimilars business to Biocon Biologics for up to $3.3 billion in cash and stocks and take an ownership stake in the Indian firm, the Pennsylvania-based company announced Monday.

The investment will give Biocon access to Viatris’ portfolio in diabetes, immunology, oncology and other noncommunicable diseases and to its “robust commercial engine” in Europe and the U.S., a statement from the Bengaluru-based…

J&J and three U.S pharmaceutical distributors have finalized a $26 billion settlement agreement over their roles in the U.S. opioid epidemic, according to multiple press releases last week. The development was triggered by “a sufficient level of participation” among claimants, according to J&J. The Washington Post reported that 46 out of 49 states have agreed to participate.

As a result, J&J will fulfill its promised…

Mentions: J&J

A consortium seeking to optimize existing cryptococcal meningitis therapy flucytosine has launched a South African Phase 1 trial to evaluate a new formulation of the antifungal, the Drugs for Neglected Diseases Initiative (DNDI) announced last week.

With funding from the European & Developing Countries Clinical Trials Partnership, DNDI and other members of the 5FC HIV-Crypto consortium will assess three sustained-release…

Pfizer’s C. difficile vaccine candidate (PF-06425090) failed to meet the primary endpoint in a Phase 3 trial, the company announced Tuesday. At final analysis, the shot showed just 31% efficacy at preventing infection after three doses, according to a Pfizer press release. Nonetheless, the jab’s 100% efficacy at preventing “medically attended” infection—a secondary endpoint—suggested a possible future direction for the product, Endpoints News…

Shah Alam-based Pharmaniaga announced a vaccine R&D tie-up last week with Thai-French biotech BioNet, part of a bid “to ensure affordable, high-quality vaccine supply and build self-sufficiency for Malaysia,” per its press release.

At the signing of the memorandum of understanding, Malaysia’s trade minister said the agreement would “reduce import dependency for critical and high-value vaccine products,” according to Malaysia’s…

Fourteen leading pharma companies released fourth-quarter and full-year 2021 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the pack, SK Bioscience generated an unprecedented $375 million in fourth-quarter revenues—a 573% jump from the same period in 2020—driven by its CMO drug substance manufacturing business, which contributed to AstraZeneca/Oxford and Novavax Covid-19…

The state of the fight: 

  • Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
     
  • Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
     
  • Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.
  AUTHORIZED VACCINES

 
The U.S. FDA lifted its…

Gilead last week offered new clinical data on the sustained efficacy of lenacapavir in heavily treatment-experienced people living with multidrug-resistant HIV. At 52 weeks, 83% of participants receiving the investigational, long-acting HIV-1 capsid inhibitor (in combination with an optimized background regimen) achieved an undetectable viral load, according to the California-based company's press release. Gilead presented the data at the…

Moderna’s mRNA-based RSV vaccine candidate (mRNA-1345) has advanced to Phase 3 in adults age 60 and older, the Massachusetts-based company announced Tuesday. The U.S. FDA Fast Track-designated shot joins RSV candidates from J&J and Pfizer in late-stage trials. Numerous other vaccine makers are also in the race to bring the first RSV jab to market.

In other RSV news, Enanta Pharmaceuticals last week touted positive Phase 2 data on…