2015, Pharmaceuticals and Pharmacy - Drug Discovery Digest

Dr. Lolettima O. Johnson Celebrated for Dedication to the Field of Medicine

The Pharma Data

DECEMBER 17, 2020

With years of pharmaceutical expertise to her credit, Dr. Johnson first garnered inspiration for her professional future during her formative years. Doctor Johnson has had an inspiring career that encompasses several aspects of the pharmacy industry. About Marquis Who’s Who® Since 1899, when A.

Pharmacy

Pharmacy Doctors Hospitals DNA

Massive Bio Launches Industry’s First NASA-Style, Oncology Clinical Trial Command Center to Disrupt and Accelerate Trial Enrollment, Featuring 72-Hour Instant Enrollment from Time of Patient Identification

The Pharma Data

JANUARY 12, 2021

Akin to the NASA Deep Space Network, SYNERGY-AI OCTCC is a real time data and communication network between patients, sites, and pharmaceutical companies, with the Massive Bio AI-enabled engine orchestrating these stakeholders for successful operations. NEW YORK–( BUSINESS WIRE )– Massive Bio, Inc. , 75N91020C00016.

Clinical Trials

Clinical Trials Trials Clinical Research Pharmaceutical Companies

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA

FDA Pharmacy Drugs Production

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Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

Science

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 The rule, will also, if finalized, address communication with State boards of pharmacy. Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

FDA

FDA Science Regulations Production

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. “Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S. New England Journal of Medicine. 2019; 381(24):2293-2303.

FDA Approval

FDA Approval FDA Production Treatment

Using clinical genomics and AI in drug development to elevate success

Drug Target Review

FEBRUARY 11, 2025

The major hurdles that pharmaceutical companies face are long lead times, high costs and a low probability of success (PoS). As recently as 2015, the likelihood of a drug in early clinical development achieving regulatory approval was around 25 percent.In

Drug Development

Drug Development Bioinformatics Drugs Small Molecule

Final Ruling on Medicare Most-Favored-Nation Drug Pricing Set for Federal Register Publication

The Pharma Data

NOVEMBER 25, 2020

A study of 600 brand-name drugs, conducted at the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing (CP3) earlier this year, found that list prices increased 159% between 2007 and 2018. in 2019, according to a report in the American Journal of Health-System Pharmacy. Another study found U.S. billion (up 11.8%

Drugs

Drugs International Pharmacy Pharmaceutical Companies

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). That meant both the pharmacist and the pharmacy where the vaccine was administered “covered persons” under the act. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. 4th 851 (6th Cir.

Testimonials

Testimonials Drugs FDA Vaccine

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 0295, 2015 WL 5022618, at *12 (N.J.

FDA

FDA FDA Approval Testimonials Vaccine

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong. 472 (2013).

FDA Approval

FDA Approval Pharmacy FDA Drugs

Drug Discovery Digest

Dr. Lolettima O. Johnson Celebrated for Dedication to the Field of Medicine

Massive Bio Launches Industry’s First NASA-Style, Oncology Clinical Trial Command Center to Disrupt and Accelerate Trial Enrollment, Featuring 72-Hour Instant Enrollment from Time of Patient Identification

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Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Webinars

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

Using clinical genomics and AI in drug development to elevate success

Final Ruling on Medicare Most-Favored-Nation Drug Pricing Set for Federal Register Publication

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

The FDA and Feasible Alternative Designs

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

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