Merck

Gilead, Merck and the TB Alliance were among the players touting new data at the 11th International AIDS Society Conference on HIV Science (IAS 2021), held in a virtual format July 18-21.

Gilead on Saturday offered promising Phase 2/3 news on lenacapavir, its investigational, long-acting HIV-1 capsid inhibitor, which it said achieved “high rates of virologic suppression” at week 26 in people living with HIV whose virus was no longer effectively responding to therapy. A company press…

Merck’s next-generation 15-valent pneumococcal conjugate vaccine (PCV) earned U.S. FDA approval in adults last week, crossing the finish line for people age 18 and older nearly six weeks after rival Pfizer’s 20-valent shot.

Even so, Merck’s Vaxneuvance seems poised to beat Pfizer in the race for the lucrative pediatric market. Merck said in May that it plans to seek FDA approval for the shot’s use in children this year.

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The state of the fight: 

Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
  Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
  Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full licensure, the companies announced Friday.
 
While the press release noted a…

The novel 24-valent pneumococcal polysaccharide vaccine (PPSV) candidate from Affinivax and Astellas has notched U.S. FDA Breakthrough Therapy designation on the strength of new Phase 2 data, the companies announced Tuesday.

The results showed that ASP3772—based on Affinivax’s proprietary Multiple Antigen Presenting System (MAPS)—was well tolerated and induced antibody responses to each of its 24 serotypes, according to the press release. The study compared the shot to two market…

The state of the hunt: 

India authorized Moderna’s shot.
  Zydus Cadila applied for authorization in India of its DNA-based vaccine, which proved 67% effective in Phase 3.
  Five Indian generics manufacturers will conduct a joint trial of Merck’s molnupiravir antiviral.


Editor’s note: The Covid-19 R&D round-up will be on hiatus next week. Please look for our next issue on Friday, July 16.

 

Approved or authorized vaccines

Iran granted…

The state of the hunt: 

China authorized Sinovac’s vaccine for children as young as age 3.
  The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
  Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.   Approved or authorized vaccines

China cleared Sinovac’s CoronaVac jab for youths ages 3 to 17, becoming the first country to offer Covid-19 vaccines to…

Merck claimed a $9 billion payday as it finalized its spinoff of women’s health, biosimilars and legacy brands company Organon, which formally launched as an independent, publicly traded entity last week.

Merck will “likely” use the funds for a future acquisition, according to Endpoints News.

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WHO released detailed notes last week from the March 22-24 virtual meeting of its Strategic Advisory Group of Experts (SAGE) on Immunization.

As in the last SAGE meeting in October 2020, the impact of the pandemic on immunization as well as guidance on Covid-19 vaccines dominated the discussion. WHO’s Immunization, Vaccines and Biologicals (IVB) department director compared the scope of Covid-19 to that of the 1918 influenza pandemic. IVB noted, however, “promising signs” of response…

The U.S. FDA approved Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV) on Tuesday, handing the company a win over rival Merck for the world’s first next-generation PCV authorization. The shot, Prevnar 20, is also under EMA review, the company’s press release said.

Merck’s 15-valent PCV candidate (V114) may win the pediatric race, however, as the multinational plans to file for a pediatric indication by the end of the year. An FDA decision on Merck’s V114 for adults is expected…

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Merck announced positive topline results last week for its investigational 15-valent pneumococcal conjugate vaccine (PCV), which met primary endpoints in two Phase 3 pediatric studies. The data suggested that V114 protects against 13 serotypes in infants who previously received one or multiple doses of Pfizer’s 13-valent shot and against 15 serotypes in children age 7 months to 17 years in a catch-up setting, according to a Merck press release.

The company said it’s on track to file…