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Delivering on the promise of gene editing

Drug Discovery World

These platforms all induce double strand cuts in the chromosomal DNA that can be sealed by the cell, leading to a specific gene disruption, or resulting in a new target site for inserting DNA segments. Early phase clinical trials for gene editing therapies. Gene editing challenges and potential solutions.

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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

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies.

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Why Trusted Research Environments are key to the future of genomics  

Drug Discovery World

The UK government endorses TREs, having recently announced an investment package of up to £200 million in TREs and digitally enabled clinical trials 4. A robust environment will contain secure access controls that can prevent and detect misuse of data.

Genome 52
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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

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. The information contained in this statement is as of December 20, 2022. Disclosure Notice.

Drugs 69
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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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Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

The Pharma Data

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.