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Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. FDA Emergency Use Authorization Statement.

Drugs 99
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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. For more information, please visit www.PAXLOVID.com.

Drugs 110
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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. For more information, please visit www.PAXLOVID.com.

Drugs 69
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Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA

The Pharma Data

We are very pleased that our comprehensive nonclinical data package has addressed all issues identified related to DRG toxicity and the FDA has reached the decision that we may proceed with our OAV-101 IT clinical trial program and initiate the STEER trial,” said Shephard Mpofu, M.D., SVP, Chief Medical Officer, Novartis Gene Therapies.

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Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

The Pharma Data

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Numbers may not add due to rounding.

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Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Our Commitment to Access. Disclosure Notice.