Business & Industry News Channel
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. 
Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. 
Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global randomized, double-blind, placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America. 
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was supplied without profit to malaria-endemic countries around the globe. 
The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.