Takeda

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


Japan’s Global Health Innovative Technology Fund announced $21 million in product development investments on Wednesday.

More than two-thirds of the awards will help advance six ongoing projects, while the rest fund four new investments: a leishmaniasis drug from Takeda and the Drugs for Neglected Diseases initiative; a malaria therapy from Eisai, the Medicines for Malaria Venture and the University of Dundee; a tuberculosis drug from Daiichi Sankyo RD Novare and the TB Alliance; and a…

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:

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…

Takeda continued its ongoing business restructuring on Friday, announcing that it will transfer four of its Type 2 diabetes medications for the Japanese market to Teijin Pharma for $1.2 billion. Takeda will continue to manufacture and supply the drugs but will hand off marketing authorization to the Tokyo-based drugmaker, the press release said.

The deal is the latest noncore asset sell-off for the Japanese company as it seeks to refocus its business on five key areas (gastroenterology…

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…

The state of the hunt:

COVAX has inked a deal for up to 40 million doses of Pfizer/BioNTech’s vaccine.
  India launched its mass vaccination campaign against Covid-19.
  China and India are both giving away vaccine doses to their neighbors.

 

Vaccines


Approved or authorized vaccines
 
China’s Sinovac jab more effective using three-week interval: A silver lining has emerged to last week’s middling news from the Butantan Institute’s…