J&J

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


Cidara Therapeutics announced Monday that J&J’s Janssen subsidiary will license the San Diego-based company’s universal influenza antiviral conjugate (AVC) technology—shelling out $27 million upfront (plus up to $753 million in milestone payments) for exclusive development and commercialization rights for Cidara’s CD388 and other influenza AVCs.

The novel immunotherapies have the potential to prevent and treat “all seasonal and pandemic” flu strains, according to Cidara’s press…

Mentions:

Sanofi CEO Paul Hudson announced on Tuesday the creation of a nonprofit unit, Sanofi Global Health, which will provide 40 lower-income countries with access to 30 of the company’s “most essential medicines,” including cardiovascular, diabetes, tuberculosis, malaria and cancer treatments.

An accompanying press release said Sanofi Global Health will be the cornerstone of the Paris-based company’s corporate social responsibility strategy for “access to medicines, support for vulnerable…

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…

The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

Médecins Sans Frontières (MSF) used Wednesday’s World Tuberculosis Day to announce that its candidate six-month, all-oral regimen is superior to locally accepted 9-20-month care standards for multidrug-resistant TB. MSF has now stopped enrollment in the Phase 2/3 trial of the treatment—containing bedaquiline, linezolid, moxifloxacin and pretomanid—based on an independent data safety and monitoring board recommendation, the press release said. MSF said it plans to share its data with WHO “as…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

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…

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…