Sanofi announced an extension on Tuesday of its 20-year partnership with WHO on human African trypanosomiasis (HAT), valuing the new commitment at $25 million over the next five years.

The funds will support disease management, population screening, an awareness campaign, capacity building and drug donation, according to a press release.

Sanofi produces the current HAT standard-of-care—the oral, 10-day fexinidazole regimen—and is…

Mentions: Sanofi, WHO, NTDs, HAT, drugs, DNDi

Beijing-based Sinovac announced last week that the China National Medical Products Administration has approved its 23-valent pneumococcal polysaccharide (PPSV23) shot—the company’s first bacterial vaccine licensure, according to the press release.

According to lot release data, Sinovac will compete for PPSV23 market share in China against Beijing Minhai, Chengdu Institute of Biological Products, Merck and Walvax.

In other Chinese…

Viatris detailed last week previously announced plans to close, downsize or divest up to 15 manufacturing sites deemed “no longer viable”—a multiyear initiative that could affect up to 20% of its global workforce.

The Pennsylvania-based generics company (formed last month through Mylan’s merger with Pfizer’s Upjohn) had promised investors that restructuring would help reduce costs by $1 billion by the end of 2024.

Mentions: Viatris, Mylan, Pfizer

The state of the hunt:

  • Pfizer/BioNTech’s vaccine won U.S. FDA Emergency Use Authorization.
     
  • The inactivated vaccine from CNBG’s Beijing subsidiary secured UAE registration.
     
  • Bharat Biotech and SII requested Indian authorization of their respective jabs.

 

Vaccines


Approved or authorized vaccines
 
The Pfizer/BioNTech vaccine extended its regulatory…

Four pharma companies announced capacity expansions this month.

AGC Biologics announced last week that it is doubling the single-use bioreactor mammalian cell-culture capacity at its Copenhagen CDMO facility for a total investment of approximately $193 million, with the start of operation scheduled for 2023.

New Jersey’s BD said last week that it will invest approximately $1.2 billion over four years to expand and upgrade…

Hemex Health released initial results at this week’s American Society of Hematology annual meeting showing that its combined anemia and sickle cell disease (SCD) test achieved 100% sensitivity and over 92.3% specificity for anemia (with 100% accuracy for hemoglobin variants) in 46 patients.

The Portland-based company expects to launch the combo test (through a software upgrade) on its low-cost, compact Gazelle platform in mid-2021 in…

Pfizer announced Tuesday that the U.S. FDA has granted priority review to the biologics license application for its 20-valent pneumococcal conjugate vaccine (PCV) for adults.

The company expects to make an application for the shot to the European Medicines Agency in early 2021.

Mentions: Pfizer, FDA, PCV, vaccines, EMA

Japan’s nonprofit Global Health Innovative Technology Fund (GHIT Fund) announced $2.2 million in drug development investments on Tuesday.

Three of the four awards support new projects for Chagas disease and malaria. The remaining award goes toward an ongoing drug discovery project between Takeda and Geneva-based Medicines for Malaria Venture.

GHIT Fund’s portfolio now includes 53 ongoing projects with $217 million invested so far…

Mentions: GHIT, R&D, drugs, Chagas, malaria, Takeda, MMV

A cystic fibrosis patient advocacy group has appealed to the U.N. Office of the High Commissioner for Human Rights over Vertex Pharmaceuticals’ drug pricing practices, alleging human rights violations that flout United Nations policies.

Prompted by a lack of access plans for newly approved Trikafta (elexacaftor in combination with tezacaftor and ivacaftor), the group hopes to prod Boston-based Vertex into licensing deals with generic…

Sanofi issued a press release Wednesday saying its lenders agreed to link the interest rates on two revolving credit facilities worth $9.7 billion to its goals of helping eradicate polio and achieving a 30% reduction in its carbon footprint.

Sanofi said it is “committed to fully embed sustainability in its business strategy” and that the move “pioneers sustainable finance in the pharmaceutical industry.”

The “innovative character…

Nature Medicine published final Phase 1 results Monday showing that a chimeric hemagglutinin-based influenza shot induced a “broad, strong, durable and functional” immune response targeting the virus’s stalk—indicating the jab’s potential as a universal flu vaccine.

However, the Mount Sinai-led team told Science that it will take “at least two years” to develop sufficient chimeric hemagglutinin from different influenza strains for late-…

WHO awarded prequalification (PQ) status last week to Biological E’s Typhibev typhoid conjugate vaccine (TCV).

Typhibev becomes the second TCV to receive the designation: fellow Hyderabad-based drugmaker Bharat Biotech won PQ for its Typbar-TCV in 2018.

Mentions: WHO, PQ, Bio E, typhoid, vaccines, TCV, BBIL

WHO’s Market Information for Access (MI4A) to Vaccines initiative published a study last month on the state of the emerging global typhoid vaccines market.

Despite characterizing the market as currently stable, the study observed significant uncertainty in the mid- to long-term global typhoid conjugate vaccine (TCV) supply-demand balance. WHO attributed the uncertainty in part to new TCV products expected to enter the market and to…

The state of the hunt:

  • The United Kingdom issued emergency authorization of Pfizer/BioNTech’s vaccine.
     
  • WHO is reviewing the Pfizer/BioNTech shot for Emergency Use Listing.
     
  • Moderna requested emergency nods for its mRNA-based vaccine from the U.S. FDA and the European Medicines Agency.

 

Vaccines


Approved or authorized vaccines

Pfizer is now seeking…

Bayer launched on Monday its Fludora Co-Max dual-action space spray solution for combating insecticide-resistant Aedes mosquito-borne arboviruses including chikungunya, dengue and Zika.

The spray combines two compounds (transfluthrin and flupyradifurone) and can be diluted with water to “maintain efficacy over greater distances” and reduce environmental impact, the press release said. Fludora Co-Max has been available in Côte d’Ivoire…

Neuroscience specialist Biogen announced last week that it has struck an all-cash $1.5 billion deal with Massachusetts-based Sage Therapeutics to jointly develop and commercialize two of Sage’s psychiatric and neurological disorder drugs in the United States. One of the drugs—zuranolone—won a U.S. FDA Breakthrough Therapy designation for major depressive disorder in 2018.

Mentions: Biogen, SAGE, FDA

CARB-X announced two new investments on Tuesday. The first, worth up to $8.77 million, will go to Germany’s Helmholtz Centre for Infection Research (HZI) and the Dortmund-based Lead Discovery Center to develop a drug to prevent S. aureus-induced lung tissue damage in pneumonia patients. The second award—up to $6.31 million to a team of HZI-affiliated researchers—will fund the development of a new treatment for P. aeruginosa infections in…

Mentions: CARB-X, HZI, LDC, AMR, drugs, GARDP, FIND, WHO, R&D

Nature Microbiology published results Monday showing that an investigational DNA-based vaccine administered with electroporation protected cynomolgus macaques against Crimean-Congo hemorrhagic fever virus (CCHF). Project contributors included the Swedish Public Health Agency, Sweden’s Karolinska Institute and the U.S. National Institute of Allergy and Infectious Diseases.

WHO listed CCHF in February among eight diseases and pathogens to…

Atlanta-based GeoVax announced Monday that it has signed a licensing agreement with the U.S. National Institute of Allergy and Infectious Diseases to support the company’s nonclinical development of vaccines against Ebola Sudan, Ebola Zaire, Lassa virus, malaria, Marburg virus and Zika virus, among other diseases.

The agreement—which also boosts the company’s oncology portfolio—gives GeoVax nonexclusive “access to certain materials and…

Britain’s government announced today its emergency authorization of Pfizer/BioNTech’s jointly developed Covid-19 vaccine, noting that the country has 800,000 doses of the mRNA-based shot ready for distribution to priority groups next week. The move makes the United Kingdom the first Western country to endorse a Covid-19 jab, ahead of the United States and the European Union, which both plan to complete their reviews of BNT162b2 in December,…