The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals

The Pharma Data

DECEMBER 17, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Hospitals

Agency IQ

AUGUST 4, 2023

BY LAURA DIANGELO, MPH AUG 3, 2023 8:21 PM CDT The Drug Supply Chain Security Act (DSCSA) and upcoming deadlines The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA

The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production

The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Virus

Agency IQ

AUGUST 25, 2023

However, the Farm Bill created a new definition for hemp and marijuana , allowing hemp to be removed from the CSA and facilitating an explosion in commercialization of CBD products. According to the agency , hemp products like CBD “must meet any applicable FDA requirements and standards, just like any other FDA-regulated product.”

Regulations

Agency IQ

NOVEMBER 27, 2023

The agency emphasized the importance of this standard when the competing, or distracting, elements convey an additional benefit – this could result in a “biased picture” of the product. These requirements are further established under 21 CFR 202.1 , which outline FDA’s expectations for prescription drug advertising.

FDA

DrugBank

NOVEMBER 7, 2023

ASHP’s full suite of drug information has been integrated into and made available through DrugBank, bringing together both company’s offerings to provide streamlined access to a broader range of high quality products. For more information, visit ashp.org and ASHP’s consumer website, SafeMedication.com.

Pharmacy

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. Expiration dates must correlate with the storage conditions stated in the product labeling.

Science

The Pharma Data

DECEMBER 30, 2020

. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning ,” the FDA notice said.

Pharmacy

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U.-level, The report notes that these products cover “a broad set of supply chain specifics.”

Regulations

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.”

Regulations

The Pharma Data

JANUARY 12, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Government

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries.

Therapies

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

Drugs

The Pharma Data

NOVEMBER 20, 2020

The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail. Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Schleifer, M.D.,

Therapies

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020. Business Highlights. government.

Production

The Pharma Data

JANUARY 16, 2021

16, 2021 — President-elect Joe Biden described an ambitious national vaccination plan on Friday that will deliver coronavirus vaccines to far more people and invoke a wartime law to boost vaccine production. Even if Biden invokes the Korean War-era Defense Production Act, it may take some time to ease vaccine shortages.

Vaccine

The Pharma Data

NOVEMBER 21, 2020

“The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. ” Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Schleifer , M.D.,

FDA

The Pharma Data

DECEMBER 29, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Hospitals

Drug Target Review

SEPTEMBER 6, 2024

To achieve this, VIVEbiotech is incessantly working to increase productivity by selecting high-producer clones, optimising the construct or transfection ratio if required and working on the optimisation of every single step of the upstream process of our manufacturing platform.

Therapies

The Pharma Data

MAY 13, 2021

Product Name: Which Arthritis Painkiller Works the Fastest? If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

Pharmacy

Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA

The Pharma Data

OCTOBER 14, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval

The Pharma Data

DECEMBER 30, 2020

. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning,” the FDA’s notice said. © 2020 HealthDay.

Vaccine

The Pharma Data

JANUARY 20, 2021

President-elect Joe Biden has unveiled an ambitious national vaccination plan that will deliver coronavirus vaccines to far more people and invoke a wartime law to boost vaccine production. Even if Biden invokes the Korean War-era Defense Production Act, it may take some time to ease vaccine shortages.

Vaccine

The Pharma Data

JANUARY 19, 2021

On Friday, Biden described an ambitious national vaccination plan that will deliver coronavirus vaccines to far more people and invoke a wartime law to boost vaccine production. Even if Biden invokes the Korean War-era Defense Production Act, it may take some time to ease vaccine shortages.

Vaccine

Drug & Device Law

JANUARY 4, 2024

The FDA, through its acting commissioner, stated: [A]s the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. biological product. . .

Vaccine

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. Specifically, they sought to require cancer warnings for purported breakdown products of ranitidine.

Testimonials

Drug & Device Law

MARCH 8, 2023

Those patches were over the counter (OTC) products. The lawsuit addressed three products – two patches and one cream. The court held that the plaintiffs had standing to assert claims for the products they actually purchased, plus other “substantially similar products.” Well, first they bought pain relief patches.

Production

Drug & Device Law

OCTOBER 25, 2023

Weigh any packaged meat at a grocery store, and there’s a decent chance the weight will be wrong. But every once in a while, a court will see through the consumer fraud case as itself being phony, and will throw the case out as if it was a package of spoiled meat. That isn’t necessarily the result of anything nefarious.

FDA

Perficient: Drug Development

MAY 21, 2025

A key Universal Design principle that embodies this idea is Equitable Use , ensuring that spaces, products, and services work for all people, regardless of ability, age, or background. Equitable Use ensures that services and products are accessible to everyone in the same way , without discrimination or exclusion.

Pharmacy

Perficient: Drug Development

MAY 20, 2025

Equitable Use ensures that products, services, and environments work for everyone in the same way , without requiring separate solutions or accommodations. Real-World Examples of Equitable Use Accessible Pharmacy Counters : Designed at heights that accommodate both standing and seated customers. What is Equitable Use?

Pharmacy