Containment, Drugs, Hormones and In-Vitro - Clinical Research Informer

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

NOVEMBER 29, 2021

Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. The primary distinctions between biologics and small molecule drugs are their size, their structural complexity, and the way in which they are produced. Blood and blood components. Allergenics. Somatic cells.

Development

Development Protein Production Hormones

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

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

Drugs

Drugs Licensing Licensing Containment

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

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

Drugs

Drugs Licensing Licensing Production

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

Pfizer

AUGUST 15, 2022

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

Drugs Vaccination Vaccine In-Vitro

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. and around the world.

Research

Research Vaccination Vaccine Drugs

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

Pfizer

JANUARY 27, 2023

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.

Marketing

Marketing Production Drugs Licensing

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing

Licensing Licensing Drugs Manufacturing

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

APRIL 27, 2021

Tomorrow, on 28 April, the ODAC will discuss Tecentriq’s accelerated approval for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Medicine

Medicine In-Vitro Antibody Development

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

The Pharma Data

SEPTEMBER 16, 2020

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.

HR

HR Medicine Hormones Trials

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

The Pharma Data

JANUARY 27, 2021

FDA Investigational New Drug (“IND”)-enabling pharmacology studies. Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. About BetterLife Pharma: BetterLife Pharma Inc.

In-Vitro

In-Vitro Containment Drugs Production

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR

HR In-Vitro Development Clinical Trials

Transforming high-throughput screening with mass spectrometry

Drug Discovery World

OCTOBER 14, 2022

HTS as a tool for drug discovery has evolved rapidly since the origin of the technique in the 1990s. HTS is widely used by pharmaceutical companies to identify compounds (or ‘hits’) that show pharmacological activity, which are used as starting points to optimise medicines during the drug discovery process.

Drugs

Drugs In-Vitro Development Production

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

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

Trending Sources

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

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

Pfizer Responds to Research Claims

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

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

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

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

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

Janssen Presents Results from Phase 3 ACIS

Transforming high-throughput screening with mass spectrometry

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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