The IMPAACT4TB consortium announced Wednesday that it will roll out a new, patient-friendly preventive tuberculosis therapy in five high-burden countries, beginning in February.

Led by African NGO the Aurum Institute (with funding from Unitaid), the program will provide a fixed-dose combination of “3HP”—a short-course TB treatment combining rifapentine and isoniazid—to Ethiopia, Ghana, Kenya, Mozambique and Zimbabwe. An agreement…

TB Alliance announced a collaboration Monday with ZebiAI to discover, develop and deliver “better, faster-acting and affordable” tuberculosis drugs using the Massachusetts-based company’s machine learning platform.

The project joins a trend in global health: artificial intelligence-driven discoveries in recent years include potential Chagas treatments identified through a Drugs for Neglected Diseases initiative collaboration and an MIT-…

WHO last week recommended the use of the monthly dapivirine vaginal ring—which it prequalified in November 2020—as a “complementary” HIV prevention choice for women. In its press release, WHO said that the ring should be used “in addition to other safer sex practices” and can be used alongside daily oral pre-exposure prophylaxis.

WHO’s Guideline Development Group (GDG) also outlined implementation and research considerations for the…

Mentions: WHO, PQ, HIV, ARV, drugs, IPM, PrEP

Four leading pharma companies released fourth-quarter and full-year 2020 financial results in January. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the pack, Abbott’s fourth-quarter total sales soared 28.4% over last year to $10.7 billion—8% above consensus estimates. Diagnostics drove the surge: the company said it has delivered more than 400 million Covid-19 tests since the start of the pandemic,…

Mentions: Abbott, Lilly, J&J, Novartis

The state of the hunt:

  • Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
     
  • J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
     
  • Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Bharat Biotech (BBIL), GSK and PATH issued a joint press release Wednesday announcing a technology transfer of GSK’s RTS,S malaria shot to the Hyderabad-based vaccine manufacturer.

The agreement transfers manufacturing of the RTS,S antigen and grants all rights to the malaria vaccine to BBIL, while GSK will continue to produce and supply the shot’s AS01E adjuvant.

GSK, development partner PATH and WHO have been looking for a long-…

Mentions: BBIL, GSK, PATH, malaria, vaccines

CARB-X announced Wednesday an award of up to $13.6 million to fund Lumen Bioscience’s investigational oral monoclonal antibody cocktail for the prevention of diarrheal diseases caused by C. jejuni and E. coli.

Lumen hopes to produce a “food-grade immuno-prophylactic drug at low cost” suitable for use worldwide, including in areas lacking temperature control for health products, according to the CARB-X press release.

GSK subsidiary ViiV notched U.S. FDA approval last week of Cabenuva, a monthly injectable combination HIV regimen (containing ViiV’s cabotegravir and J&J’s rilpivirine) for adults. The shot was approved by the European Medicines Agency in December 2020 and received a nod from Health Canada in March 2020.

The FDA also approved ViiV’s cabotegravir tablets (Vocabria), which it recommends be taken in combination with oral rilpivirine…

Mentions: GSK, ViiV, FDA, HIV, drugs, ARV, EMA, J&J, HIVR4P, bNAbs, Merck, PrEP

Meissa Vaccines has dosed the first participant in a Phase 2 challenge trial of its intranasal live attenuated respiratory syncytial virus (RSV) vaccine candidate, MV-012-968, the company announced last week.

The San Francisco biotech also released complete Phase 1a data showing that the vaccine was safe, well-tolerated and induced mucosal antibodies in most adult recipients. A dose of the RSV candidate was similarly tolerable and…

Mentions: Meissa, RSV, vaccines, FDA

Colorado-based diagnostics firm InDevR announced last week the commercial launch of its VaxArray measles and rubella (MR) antigen quantification kit. The MR vaccine potency test measures antigen content in five hours—a “fraction” of the 10-14 days needed for conventional tissue culture infectious dose measurement—potentially reducing the cost per dose of the final vaccine, according to the press release.

InDevR developed the Gates…

For the seventh time in a row, GSK topped the Access to Medicine (AtM) Foundation’s ranking of leading pharma companies’ efforts to provide access to their products in low- and middle-income countries, according to the 2021 AtM Index, launched Tuesday. But the new index showed Novartis gaining on GSK compared to 2018—with the difference in scores falling to only 1.2%.

Overall, 17 of the 20 companies in the index improved their…

Vaxess announced last week that the National Science Foundation and the U.S. Defense Advanced Research Projects Agency have awarded the Massachusetts company up to $2 million to develop mRNA-based vaccines and “other medical countermeasures.” The projects will use the company’s MIMIX smart release patch technology to develop refrigeration-free, single-dose products.

Vaxess has several deals in the works for its MIMIX technology,…

The state of the hunt:

  • COVAX has inked a deal for up to 40 million doses of Pfizer/BioNTech’s vaccine.
     
  • India launched its mass vaccination campaign against Covid-19.
     
  • China and India are both giving away vaccine doses to their neighbors.

 

Vaccines


Approved or authorized vaccines
 
China’s Sinovac jab more effective using three-week interval: A…

State-owned Sinopharm announced last week that two senior executives have resigned for “personal reasons.”

Stepping down on the same day, Li Zhiming served as the Chinese conglomerate’s executive director and board chair, while Li Hui was a director, general manager and member of the strategy and audit committee of drugs subsidiary China National Medicines Corp.

Media depicted the moves as surprising—but offered no alternative…

The Center for Infectious Disease Research and Policy (CIDRAP) released a draft Tuesday of its Influenza Vaccines Research and Development Roadmap for public comment and review.

The 10-year plan for improving seasonal flu vaccines and developing new universal products will also provide “a mechanism for benchmarking and tracking progress” in R&D and will incorporate lessons from Covid-19 vaccine development “as appropriate,” the…

GSK and Novartis jointly pledged funding on Tuesday to research the link between genetic diversity and response to malaria and tuberculosis drugs in African patients.

A joint press release said the companies will invest a combined $3.6 million over five years in their Project Africa Genomic Research Approach for Diversity and Optimising Therapeutics (GRADIENT) collaboration, which will release all collected data to the public.

Merck’s four-year, $2.54 billion patent-infringement saga against Gilead finally ended on Tuesday after the U.S. Supreme Court refused to hear an appeal of a lower court’s ruling that Merck’s hepatitis C treatment patent was invalid, Reuters reported.

Bloomberg Law said the decision—based on the claim that the patent was overly broad—could expose more patents to challenges.

Mentions: Merck, Gilead, hep C, patents

Britain’s University of Oxford announced Tuesday a $136 million donation from UK-based chemical giant Ineos to establish a research institute to combat antimicrobial resistance.

The new Ineos Oxford Institute for AMR Research will unite the university’s chemistry and zoology departments in an effort to design new human drugs and “novel antimicrobials just for animals,” the press release said.

Mentions: Oxford, Ineos, AMR, drugs, IOI

Massachusetts-based Thermo Fisher announced last week its $877 million all-cash acquisition of Novasep’s Belgian viral vector manufacturing business, Henogen. The purchase will help Thermo Fisher “expand its capabilities for cell and gene vaccines and therapies globally,” the press release said.

Fellow CDMO Fujifilm Diosynth Biotechnologies also has new manufacturing muscle in the works. Fujifilm and its collaborator, the Massachusetts…

Covid-19 dominated the 39th J. P. Morgan Healthcare Conference (JPM), held virtually this week instead of at its customary haunt, San Francisco’s Westin St. Francis. Beyond much coronavirus chatter, the event also featured one major M&A announcement (Sanofi touting its $1 billion Kymab buy) and additional vaccine news from companies including GSK (for RSV), Moderna (for flu, HIV and Nipah) and Takeda (for dengue).

BioNTech CEO Uğur…