Merck

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

The Access to Medicine (AtM) Foundation last week published a pediatric analysis of additional results from its 2021 AtM Index, finding just 7% of pharmaceutical companies’ R&D is for children under 12, despite significant gaps in treatment options for children.

The report praised GSK, Johnson & Johnson and Sanofi for being “the most active” in developing pediatric versions of products, and also named examples of drugs that “could each make a big difference” for LMICs: Eli…

Gilead and Merck announced on Monday a deal to co-develop and market long-acting HIV treatments combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s nucleoside reverse transcriptase translocation inhibitor candidate, islatravir.

According to the press release, Gilead and Merck will share costs at a ratio of 60% and 40%, respectively, and lead commercialization efforts in different geographies depending on the product formulation.

Mentions:

The state of the hunt:

J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
  A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
  Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization or death in people with mild or moderate Covid-19 at high risk of progression…

Merck, Gilead and ViiV captured headlines for their HIV portfolios at this week’s annual Conference on Retroviruses and Opportunistic Infections (CROI).

First, Merck announced on Monday that a reformulated version of its islatravir NRTTI subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP) may provide protection for “at least one year,” based on Phase 1 data. A company researcher told NAM Aidsmap that planned Phase 2 trials of the new version will be “very similar” to the Phase…

Mentions:

The state of the hunt:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…

Merck announced Tuesday the fifth round of global grants in its Merck for Mothers program, which funds organizations working to increase health equity in maternity care and support, according to its press release.

New grantees include a UNICEF program in Argentina focused on adolescents from indigenous communities and a Save the Children-backed project to support pregnant teenagers and young mothers in rural Moldova.

While describing the 10-year-old Merck for Mothers as a “$500…

Merck announced last week that it is buying Massachusetts-based immune diseases specialist Pandion Therapeutics for $1.85 billion. The deal hands Merck the biotech’s “robust pipeline” of precision immune modulators, the joint press release said.

The transaction is expected to close in the first half of 2021, per the press release.

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

Leading the round, Gilead’s fourth-quarter revenue soared 26% over last year to $7.4 billion, beating consensus estimates by 4%. Veklury (remdesivir) drove the surge with $1.9 billion in quarterly sales: the antiviral now treats one in two hospitalized Covid-19 patients in the United States, according to the…

The state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…