Novartis and Medicines for Malaria Venture (MMV) announced last week positive Phase 2b results for their novel non-artemisinin combination antimalarial. The study tested ganaplacide with a new formulation of lumefantrine optimized for once-daily dosing.

This combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite, the press…

Novartis’ Sandoz subsidiary will pay $185 million under an agreement with the U.S. government to resolve civil liabilities related to alleged price-fixing of generic drugs, the Department of Justice announced last week. The payment adds to an earlier penalty of $195 million to settle criminal charges in the matter.

The government also announced related civil settlements with Taro Pharmaceuticals (for over $213 million) and Canada-based…

WHO published results last week from its biennial Expert Committee on the Selection and Use of Essential Medicines meeting, adding 20 new treatments to its Model List of Essential Medicines (EML) and 17 to its children’s list (EMLc).

The additions include “new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials to treat…

The state of the fight: 

  • COVAX will overhaul its vaccine allocation methodology.
     
  • An investigational antiviral pill from Merck and Ridgeback Biotherapeutics cut the rate of hospitalizations or death some 50% in a Phase 3 trial.
     
  • India plans to resume Covid-19 vaccine exports by the end of October.

 

Approved or authorized vaccines

 
The AstraZeneca/Oxford Covid-19…

AstraZeneca announced a deal last week with VaxEquity to develop and commercialize the latter’s self-amplifying RNA (saRNA) therapeutics platform.

According to the press release, AstraZeneca will pay the Imperial College London spinout up to $195 million in milestones, plus additional royalties, for each approved program. The companies will collaborate on up to 26 undisclosed drug targets.

Imperial College London and Hong Kong’s…

Local media has reported that leading vaccine raw materials supplier Cytiva is expanding production facilities to meet surging demand spurred by the Covid-19 pandemic.

Firstly, Korea Biomedical Review said last week that the Massachusetts-based company is investing $52.5 million in Korea between 2022 and 2024 to build facilities for manufacturing single-use bioreactors for vaccine production.

Then, Utah’s Cache Valley Daily said…

Pfizer announced Monday that it has launched a Phase 1 trial of its mRNA-based single-dose quadrivalent seasonal influenza vaccine, which will be tested against a rival U.S. FDA-approved standard quadrivalent flu shot in healthy adults ages 65-85 in the United States. The trial marks the “first in a planned wave of programs” leveraging the mRNA technology for influenza, the press release said.

If the candidate is approved, Pfizer’s…

Pfizer enjoyed three boosts over the past week to its booming vaccine portfolio, already buoyed by global sales of Covid-19 shots.

Firstly, the company settled a patent dispute last week with Merck over their rival pneumococcal conjugate (PCV) shots. Under the settlement, Merck will pay Pfizer 7.25% of its worldwide net sales of all PCV products through the end of 2026, and 2.5% of net sales of PCV products from 2027-2035, according…

GSK subsidiary ViiV announced Tuesday that it will pay Shionogi nearly $27 million upfront (plus royalties and $20 million in milestones) for rights to the Osaka-based drugmaker’s S-365598 third-generation investigational integrase strand transfer inhibitor (INSTI) for potential use in ultra-long-acting HIV regimens (dosing intervals of three months or longer).

Preliminary data has shown that S-365598 “has a high genetic barrier and a…

Mentions: GSK, ViiV, Shionogi, HIV, drugs, FDA, PrEP

The state of the fight: 

  • CanSino and Pfizer/BioNTech released positive news on their respective vaccines in children.
     
  • WHO added Regeneron and Roche’s monoclonal antibody cocktail to its list of recommended therapeutics.
     
  • California’s NantWorks plans a $200M investment to produce Covid-19 and other vaccines in South Africa.
Approved or authorized vaccines

 
Pfizer and…

The New England Journal of Medicine published Phase 3 results last week showing that one dose of Bharat Biotech’s typhoid conjugate vaccine (Typbar-TCV) was safe and 83.7% effective at protecting children ages 9 months to 12 years against the disease after 18-24 months of follow-up. The results, from a study in Malawi, are consistent with a previously reported efficacy of 81.6% among Nepalese children, the researchers said.

Malawi will…

Mentions: BBIL, TCV, typhoid, vaccines

A new nonprofit—dubbed the Incubator for Antibacterial Therapies in Europe (INCATE)—will support the European-based development of novel therapies, diagnostics and interventions to combat antimicrobial resistance. A Novo Holdings REPAIR Impact Fund director announced the incubator’s launch Sunday in a LinkedIn post.

INCATE’s support—a mix of consulting, business networking, and up to approximately $290,000 in non-dilutive funding (for…

Touting progress toward its November 2020 pledge to have a net-zero impact on climate and “net positive impact on nature” by 2030, GSK announced Monday a $68 million investment in renewable energy and carbon reduction at manufacturing sites, including facilities in Scotland and New York.

The investment will also support a new R&D program to reduce greenhouse gas emissions caused by the propellant in GSK’s medicine inhalers, which…

Mentions: GSK, CSR, climate change

PAHO on Tuesday named Brazil’s Bio-Manguinhos and Argentina’s Sinergium Biotech as regional hubs for the development and production of mRNA-based vaccines in Latin America.

Reuters reported that the initiative—backed by Unitaid’s Medicines Patent Pool among others—seeks to “tap existing manufacturing capacities to help transfer vaccine technology developed by Moderna,” with an immediate emphasis on the Massachusetts-based company’s…

Serum Institute of India (SII) was on the move again this week. Its Covid-19 marketing subsidiary, Serum Life Sciences (SILS), will buy a 3.9% stake in Oxford Biomedica for just over $68 million, according to a Wednesday announcement from the British CDMO. Oxford Biomedica will use the investment to build a manufacturing plant at its existing “Oxbox” location by mid-2023 to supply “viral vector-based products, including vaccines.”

Last…

Takeda announced Wednesday four new partnerships and nearly $38 million in investments for its annual Global Corporate Social Responsibility (CSR) Program, which makes “long-term commitments to strengthen health systems and improve access to healthcare” in developing and emerging countries.

The new investments include $8.7 million to IntraHealth International for healthcare access, over $8.1 million to Jhpiego’s iWIN project for…

Mentions: Takeda, CSR

The state of the fight: 

  • A U.S. regulatory committee endorsed booster doses for vulnerable people and those over age 65.
     
  • Kenya outlined plans to start fill-finish production of Covid-19 shots in early 2022.
     
  • An SII subsidiary scooped up a 15% stake in Biocon’s biologics unit as the companies launched a strategic alliance to produce and commercialize vaccines.
Approved or authorized…

Dhaka-based Beximco Pharmaceuticals will become the majority owner of Sanofi Bangladesh under a share purchase agreement announced Tuesday, per local media.

The parties provisionally agreed to a $49 million deal in January 2021, according to New Age.

Mentions: Beximco, Sanofi, M&A

The Clinton Health Access Initiative (CHAI), Hyderabad-based Laurus Labs and Unitaid announced a deal Monday to accelerate the development, commercialization and registration of a generic version of J&J/Janssen’s fixed-dose combination HIV treatment darunavir/ritonavir (DRV/r) for children.

Laurus Labs gets a “financial incentive” for a portion of the development and commercialization costs for the second- and third-line treatment,…

J&J touted positive Phase 3 data Monday showing that its Janssen subsidiary’s Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola vaccine regimen—co-developed with Bavarian Nordic—induced antibody responses against the Ebola Zaire virus in 98% of children and adults 21 days after the second dose.

In the adult cohort, immune responses persisted for at least two years, while a booster dose with Zabdeno after two years induced a strong…