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European Commission Approves LORVIQUA® as a First-Line Treatment for ALK-Positive Advanced Lung Cancer

Approval based on results from Phase 3 CROWN trial, showing LORVIQUA reduced risk of disease progression or death by 72% in newly diagnosed individuals compared to XALKORI ® (crizotinib)

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) granted marketing authorization for LORVIQUA ® (lorlatinib, available in the U.S. under the brand name LORBRENA ® ) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

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Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

  • CHMP recommends PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for use in adults with COVID-19
  • If authorized, PAXLOVID will be the first COVID-19 oral treatment recommended in the EU
  • European Commission decision on conditional marketing authorization expected imminently

Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing authorization (CMA) of Pfizer's PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.

"This expression of confidence in PAXLOVID comes at a critical moment as Europe addresses the ongoing challenges of the pandemic and as infection rates are on the rise in many countries across the globe," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of PAXLOVID globally. Pending conditional marketing authorization from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible."

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 Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

  • First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies' Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

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