Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation. Scientific Rationale.

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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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FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

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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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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . When Does an IND go into Effect? .

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is leading by example and has launched new packaging that contains no aluminum for their soft catheter SpeediCath Flex.

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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. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

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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. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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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. . TOKYO and CAMBRIDGE, England , Feb. ” About Sosei Heptares.

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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

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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XTalks

OCTOBER 8, 2024

The approval was awarded to Abbott’s Alinity m MPXV assay, the first mpox in vitro diagnostic (IVD) listed under the WHO’s Emergency Use Listing (EUL) procedure. It is intended for use by trained clinical laboratory professionals skilled in PCR techniques and IVD procedures. Mpox has led to at least 635 deaths in the DRC this year.

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Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

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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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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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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.

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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.

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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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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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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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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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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. Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001). NEW YORK–(BUSINESS WIRE)– Pfizer Inc. and Scedosporium spp).

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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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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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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).

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FDA Law Blog

FEBRUARY 23, 2025

Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. By Steven J. Gonzalez & Allyson B. See 21 C.F.R. But this guidance has its limitations.

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FDA Law Blog

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

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FDA Law Blog

NOVEMBER 28, 2021

Nevertheless, FDA has said that in its review of 125 EUAs applications for COVID-19 LDTs, 82 contained design or validation issues that the agency believed needed to be resolved before an EUA could be authorized. [1] This suggests that the LDT status quo ante has been restored. This rationale is weak, at best. legal memo available here ).

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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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