The Pharma Data

AUGUST 28, 2020

The Department of Health and Social Care (DHSC) said this could include training a wider range of existing NHS staff, as well as student doctors and nurses. The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. She began her career as a clinical oncologist before completing doctoral and post-doctoral training in carcinogenesis and tumour biology.

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The Pharma Data

SEPTEMBER 28, 2021

As regulators, we recognize we’ve a crucial task before us which will require us to act expeditiously while undertaking a particularly meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population.

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The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. relevant government policies and regulations relating to our industry. Amorette Barber of Longwood University will be heading up our chPD1 program. “We believe Prof. Link to her profile: [link].

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Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP). The meeting will take place virtually on April 13, 2023, from 11:00 AM to 3:00 PM ET. There have been challenges in gene therapy development.

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Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

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The Pharma Data

NOVEMBER 4, 2020

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. million and $8.9 million and $5.7

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. All the colors had the same brightness. The black bars denote untreated eyes, and the gray bars denote treated eyes. From McKyton et al.

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. All the colors had the same brightness. The black bars denote untreated eyes, and the gray bars denote treated eyes. From McKyton et al.

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Therapies RNA DNA Engineering 52

Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

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The Pharma Data

NOVEMBER 9, 2020

“This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said David A. Ricks, Lilly’s chairman and CEO.

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The Pharma Data

JANUARY 15, 2021

Achieving hematologic complete response is an important treatment goal, and today’s approval based on this clinical endpoint will provide doctors and the larger medical community with a new option to treat newly diagnosed patients.”. Davis Myeloma and Amyloid Program, Tufts Medical Center, and ANDROMEDA study investigator.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. Demand for cannabis products will continue, and meeting that demand only in a regulated, legal marketplace better protects consumers. January 29, 2024).

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. 7) BNT162b2 has not been approved or licensed by the U.S. Hospital products, which grew 10% operationally to $2.3 Chantix in the U.S.,

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. I can't patent it and license the fact that it is safe and feasible to do a challenge study with disease sample X to my competitors. That's what my Zika study was for.

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Codon

JANUARY 8, 2025

Autonomous Chemical Research with Large Language Models ( Nature ) Interview With Erika DeBenedictis ( Federation of American Scientists ) The Quest for a Strep A Vaccine There is no licensed vaccine to prevent strep A infections, which kills perhaps a thousand people yearly in the United States. He was unable to do so.

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

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Drug & Device Law

SEPTEMBER 29, 2023

The defendant was a “naturopathic doctor” (which is new to us, but apparently is a licensed professional who treats patients using mainly natural remedies) who had a prior misdemeanor conviction for selling misbranded drugs. So we read the Marschall case and its treatment of misbranding with some interest.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. You never need an authorization from a licensed professional to buy pork or fireworks. Ogden , 22 U.S.

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Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. As Bexis’ article indicates, we like the chances of FDA regulation and the Supremacy Clause where there is a level playing field.

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Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 23 in its current form. at *3) Rule 23(c)(4) partial class.

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Production Doctors Licensing Licensing 52

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

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Drug & Device Law

JUNE 1, 2022

We’ve been writing for a while about cases rejecting someone’s insistence that a doctor prescribe ivermectin for Covid-19, even when that doctor (or hospital) thinks such use of ivermectin is not appropriate medical care – is, in fact, horsebleep. ?. You will, of course, say this very respectfully.).

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Drug & Device Law

MARCH 9, 2022

When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., So much for judicial gate-keeping, Inadequate Warnings to Doctors. we almost see the good side of the mesh MDL court’s decision to toss all FDA issues out of the litigation.

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