GSK subsidiary ViiV and the UN-backed Medicines Patent Pool announced Monday their signing of a “first-of-its-kind” voluntary licensing agreement to allow four upper-middle-income countries to buy generic versions of HIV regimens containing ViiV’s dolutegravir.

Under the deal terms, “selected generic manufacturers” can supply medicines recommended by WHO or the U.S. Department of Health and Human Services to Azerbaijan, Belarus,…

Maryland-based nonprofit International Partnership for Microbicides (IPM) announced Monday that WHO has prequalified its monthly vaginal ring (containing Johnson & Johnson’s dapivirine antiretroviral) for the prevention of HIV infection.

IPM said in its press release that it will apply for country approvals as early as this year—initially in eastern and southern Africa—using WHO’s simultaneous collaborative registration procedure…

Mentions: IPM, WHO, PQ, J&J, HIV, ARV, drugs

Six leading pharma companies released third-quarter financial results in November. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, SK Bioscience’s third-quarter sales surged 98% year-over-year to $89.7 million, driven by skyrocketing flu shot sales and robust performances from its shingles and varicella vaccines. The SK Chemicals subsidiary expects revenues from its contract manufacturing…

Particles for Humanity announced last week that the Gates Foundation has awarded it $5 million to evaluate a novel single-injection vaccine delivery technology that “delivers all the doses required for full immunization in one injection.”

According to the press release, the Massachusetts Institute of Technology spinoff has so far received $14 million in total funding from the foundation to transform early-stage technologies into…

PNAS published a preclinical study Monday of commonly used tetracycline-based antibiotics, including U.S. FDA-approved methacycline, showing that these drugs may slow infection and reduce neurological problems caused by the Zika virus, according to an NIH press release.

The joint U.S. National Institutes of Health and Georgetown University preclinical study also identified J&J’s failed anti-Alzheimer’s drug, JNJ-404, and Merck’s…

Mentions: antibiotics, Zika, NIH, J&J, Merck, drugs

The state of the hunt:

  • The efficacy of AstraZeneca’s AZD1222 vaccine candidate may reach 90%, but critics questioned the reported results.
     
  • New, more detailed data on Russia’s Sputnik V vaccine indicates 91.4% efficacy.
     
  • Regeneron’s mAb cocktail secured U.S. FDA Emergency Use Authorization.

 

Vaccines


Phase 3 candidates

AstraZeneca’s two-shot…

Britain’s Emergex Vaccines announced last week that it has raised $11 million from “new and existing investors” to develop its synthetic T-cell vaccines (delivered using a thermostable microneedle patch), including candidates for Covid-19, dengue and pandemic influenza. The company raised $11 million in Series A financing in January, in part to advance its Phase 1 dengue shot.

Roche announced Tuesday that the U.S. FDA has approved its influenza treatment Xofluza (baloxavir marboxil) as a post-exposure prophylaxis in people ages 12 and older who’ve had contact with someone with flu—the first single-dose tablet to receive the indication.

In a separate press release last week, Roche said the European Medicines Agency has recommended the drug to treat uncomplicated influenza in patients 12 and older.

Mentions: Roche, FDA, flu, PrEP, drugs, EMA

The race between Merck and Pfizer for the world’s first approved next-generation pneumococcal conjugate vaccine (PCV) continued this week with Merck’s announcement Monday that it has submitted licensure applications to the U.S. FDA and the European Medicines Agency (EMA) for its V114 15-valent PCV for use in adults.

Pfizer filed an FDA application for its 20-valent PCV in adults just last month, saying it planned an EMA application in…

Mentions: Merck, Pfizer, PCV, vaccines, FDA, EMA

Two U.S. FDA priority review voucher (PRV) transactions took place on Monday: Belgian immunology specialist Argenx paid $98 million to Bayer for the pharma giant’s voucher and California-based Eiger BioPharmaceuticals sold its voucher to an undisclosed buyer for $95 million.

PRVs are now routinely selling for less than one-third of their 2015 high of $350 million, according to data monitored by Duke University’s David Ridley, a creator…

An approved pediatric formulation of tafenoquine drew nearer last week after GSK and Medicines for Malaria Venture released new data showing that their single-dose radical cure for P. vivax malaria is safe and effective in children and adolescents ages 6 months to 15 years.

The Tafenoquine Exposure Assessment in Children (TEACH) study evaluated dosages of the oral 8-aminoquinoline drug based on weight, finding safety “consistent with…

Mentions: GSK, MMV, malaria, drugs

VBI Vaccines announced Monday that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Sci-B-Vac three-antigen hepatitis B vaccine candidate. The Massachusetts-based biotech also plans to submit a biologics license application to the U.S. FDA in “the next couple of weeks,” according to the press release.

Mentions: VBI, EMA, hep B, vaccines, FDA

Newly formed generics giant Viatris announced Monday that the U.S. FDA has tentatively approved its 10mg pediatric dolutegravir antiviral tablets for oral suspension for treatment of HIV-1.

According to the press release, the tentative approval—granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—permits the distribution in certain PEPFAR countries of generic products still under U.S. patent or exclusivity…

The state of the hunt:

  • Pfizer and BioNTech submitted a U.S. FDA Emergency Use Authorization request for their vaccine.
     
  • Lilly’s rheumatoid arthritis drug Olumiant snagged an EUA (in combo with remdesivir) as a Covid-19 treatment.
     
  • WHO formally issued a conditional recommendation against using Gilead’s remdesivir in hospitalized Covid-19 patients.

 

Vaccines


Australia’s government on Monday announced a 10-year, $730 million deal with CSL subsidiary Seqirus for the long-term supply of “critical health products,” including pandemic and seasonal influenza vaccines.

Meanwhile, Seqirus also said in a press release Monday that it will invest $584 million in building a cell-based vaccine manufacturing facility in Melbourne to produce flu vaccines as well as its proprietary MF59 adjuvant, a Q…

Mentions: CLS, Seqirus, flu, vaccines

CARB-X announced Wednesday an award of up to $14.3 million to fund Clarametyx Biosciences’ new treatment for serious bacterial biofilm infections.

Ohio-based Clarametyx is developing a monoclonal antibody (CMTX-101) to treat moderate-to-severe pneumonia through co-administration with standard antibiotic regimens, according to the company’s press release.

Gilead, GSK’s ViiV subsidiary and Merck all made HIV product announcements this week.

First, Merck said Monday that the Gates Foundation will support Phase 3 trials in sub-Saharan Africa of its islatravir nucleoside reverse transcriptase translocation inhibitor (NRTTI) as a once-monthly oral pre-exposure prophylaxis (PrEP) in women and adolescent girls at high risk for acquiring HIV-1. Enrollment could start as early as 2021, with Merck…

Mentions: Gilead, GSK, ViiV, Merck, HIV, BMGF, PrEP, FDA, EMA, drugs

Three investors have committed an initial $250 million to a new African pharma venture, promising “significant cost savings for healthcare providers” and a broader range of available drugs in underserved markets.

African investment firm Development Partners International, British impact investor CDC Group and the European Bank for Reconstruction and Development launched the project Tuesday with the announcement of two acquisitions:…

British researchers have developed a rapid diagnostic blood test that can detect and distinguish between the six strains of T. cruzi, the parasite that causes Chagas disease, Imperial College London announced last week.

Co-developed with the London School of Hygiene and Tropical Medicine and Kent-based nonprofit TroZonX17 (among others), the technology may lead to “widespread, inexpensive testing,” according to a TroZonX17 press release…

South Korea’s Research Investment for Global Health Technology (RIGHT) Fund launched a new RFP this week, awarding up to $452,000 (per grant) for early-stage vaccines, therapeutics, diagnostics and digital health technology projects tackling infectious diseases in developing countries.

Applicants must include at least one Korean entity and submit their proposals by December 18. RIGHT Fund has so far invested $25.3 million in 22 R&D…