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. Dr. Graham earned an M.D.,

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The Pharma Data

APRIL 28, 2021

a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems.

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Pfizer

JANUARY 27, 2023

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

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The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

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Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1

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XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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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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The Pharma Data

JANUARY 27, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, announces it has entered into an agreement with Eurofins Discovery for TD-0148A’s U.S. VANCOUVER, Jan.

In-Vitro 52

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Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1,

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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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Drug Discovery World

AUGUST 2, 2023

Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1. Conformational changes in the Ras membrane proximal domain facilitate the phosphorylation of GDP to GTP and the kinase domain activation.

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XTalks

JANUARY 8, 2021

The FDA instituted STeP to help developers of safer devices and diagnostics for conditions excluded from the Breakthrough Devices Program to benefit from prioritized review and enhanced communication with the agency throughout the development process. This includes non-life-threatening or reasonably reversible conditions.

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Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S. and around the world.

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The Pharma Data

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. Beverley, MA) (“Adeptrix”). I look forward to updating the market when we have definitive clinical performance data.”. Source link.

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Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. NEW YORK, December 20, 2022 -- Pfizer Inc.

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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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Drug Discovery World

DECEMBER 29, 2023

Given their role in regulating cellular functions, it comes as no surprise that membrane proteins are the primary targets for the majority of currently marketed therapeutics. Consequently, the selection and optimisation of membrane mimetics is one of the main bottlenecks in structural and functional studies of membrane proteins.

Protein 52

Protein In-Vitro Research Containment 52

Pfizer

NOVEMBER 23, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). This agreement will supply participating countries up to 3.4 million treatment courses upon orders being placed.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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The Pharma Data

DECEMBER 29, 2020

Program includes development of a heat-sensitive fluorescent SARS-CoV-2 detection assay through patient mucosal sampling. Due to the breadth of our antibody discovery capabilities, IPA is very well positioned to deliver anti-virus antibodies in various formats, opening doors for inclusion in different therapeutic and diagnostic approaches.

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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. Sosei Heptares will have exclusive, full global rights to all molecules identified and directed to the targets for development by Sosei Heptares.

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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).

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 per share amounts).

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FDA Law Blog

NOVEMBER 28, 2021

Javitt — On November 15, HHS announced that it was withdrawing the prior administration’s policy that prevented FDA from requiring premarket review of laboratory developed tests (LDTs) without notice and comment rule making. Gibbs & Gail H. See the prior post on this policy here. This rationale is weak, at best. emphasis added).

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The price of that prize is incalculable. Moderna’s COVID-19 Vaccine. University of Oxford and AstraZeneca COVID-19 Vaccine.

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