EMA

Otsuka announced last week that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Deltyba, the Japanese firm’s dispersible delamanid tablet, for multidrug-resistant pulmonary tuberculosis in patients of all ages weighing at least 10 kilograms (22 pounds).

Mentions:

Swedish CDMO Recipharm announced Tuesday that it will build a fill-finish facility in Morocco to supply vaccines and biotherapeutics in Africa by 2023. According to the press release, the Moroccan government and local banks will invest around $500 million to support the project.

FiercePharma reported that the facility will have an annual capacity of about 300 million units.

In other Recipharm news, Moderna announced last week that its Monts, France site has begun drug product…

Valneva announced Wednesday that the U.S. FDA has granted its VLA1553 single-shot chikungunya vaccine candidate (currently in Phase 3) Breakthrough Therapy Designation—adding to the PRIority MEdicines (PRIME) designation the EMA awarded the French company’s jab in 2020 and the FDA Fast Track status it received in 2018.

The state of the hunt:

Moderna’s mRNA-based vaccine secured Emergency Use Listing from WHO.
  Merck entered voluntary licensing agreements with five Indian drugmakers for its investigational antiviral molnupiravir.
  Biological E’s subunit vaccine candidate advanced to Phase 3.

 

Vaccines


Approved or authorized vaccines
    
WHO granted Moderna’s vaccine Emergency Use Listing on Friday, according to a press release from the…

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


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…

Takeda has asked the European Medicines Agency to approve its tetravalent dengue vaccine candidate, the company announced last week. In parallel, the agency will consider recommending the shot for countries outside the European Union through the EU-M4all (previously Article 58) procedure, according to the press release.

Takeda said it plans to seek additional approvals for TAK-003 this year in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand…

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…

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…