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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

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

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

Pfizer

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 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.

Drugs 99
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Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

HR 52
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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Blood and blood components. Allergenics. Somatic cells.

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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.

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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

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, 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.

Drugs 110