Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . 21 CFR 312.40(a)

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The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. “Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline,” said Dr. Heinrich Jehle, managing director of 3a-Diagnostics.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

XTalks

JANUARY 8, 2021

The guidance for the voluntary STeP program provides additional support to developers of devices that significantly improve on existing products but do not meet all the criteria for the Breakthrough Devices Program. Addressing this, the final guidance now contains additional information on eligibility criteria. More Specifics.

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Pfizer

DECEMBER 13, 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.

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Pfizer

JANUARY 27, 2023

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. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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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.

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Research Vaccination Vaccine Drugs 112

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.

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

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Drugs Licensing Licensing Containment 69

The Pharma Data

APRIL 28, 2021

Fosmanogepix has demonstrated broad-spectrum activity in-vitro and has shown wide distribution to various tissues including the brain, lung, kidney and eye. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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Clinical Trials Clinical Trials Containment In-Vitro 40

FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

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Production In-Vitro Marketing Clinical Trials 52

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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

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Licensing Licensing Drugs Manufacturing 40

The Pharma Data

JANUARY 27, 2021

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. This approach makes Eurofins Discovery uniquely qualified to fulfill the needed studies for this innovative product.

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In-Vitro Containment Drugs Production 52

Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. DNA cloning is a largely accepted technique, however, it has been regulated carefully.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. The price of that prize is incalculable. Moderna’s COVID-19 Vaccine.

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Vaccination Vaccine Antibody Life Science 92

The Pharma Data

JANUARY 27, 2021

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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Drug Discovery World

AUGUST 2, 2023

Genoscience Pharma’s Philippe Halfon and Eric Raymond share their expertise on targeting the recycling of unsustainable production of palmitoylated cancer-associated proteins. Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1.

Protein 52

Protein Immune Response In-Vitro Regulation 52

The Pharma Data

JANUARY 13, 2021

To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation).

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. . TOKYO and CAMBRIDGE, England , Feb. ” About Sosei Heptares.

Drugs 52

Drugs Protein In-Vitro Development 52

The Pharma Data

DECEMBER 29, 2020

The academic partners of the consortium have been awarded €350,000 from Health Holland under the Eureka Program to develop a SARS-CoV-2-specific therapeutic nanomedicine that is administered via nasal inhalation and that can also be used for in vitro diagnostics. About Radboudumc.

Antibody 52

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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 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. 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 per share amounts). Adjusted Income (2).

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