Fierce BioTech

MARCH 29, 2024

Is your pharmacy ready to make the leap? Listing Image Inovalon Logo.png Listing Introduction Pharmacists are being called to operate at the top of their license to close gaps in care. Learn how your pharmacy can prepare today for a future of pharmacy focused on patient outcomes. Click here to login.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. To accomplish this, we pay careful attention to both dosing and sample collection.

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Advarra

APRIL 30, 2024

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. The FDA 1572 Form, CV, financial disclosure form, and medical license should all show consistency regarding the PI’s name. Both the medical licenses and nurse licenses need to be up to date.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. By Larry K.

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Policy Prescription

DECEMBER 22, 2021

Mark Rubio (R-FL) and Amy Klobuchar (D-MN) , called the “Domain Reform for Unlawful Drug Sellers Act’’ or, for short, the ‘‘DRUGS Act,’’ could effectively end online access to safe and affordable imported medicines for Americans. But the FDA already has a program for tackling online opioid drug dealers.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. 48365, 48369 (July 27, 2023).

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Drug Channels

OCTOBER 10, 2023

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S. reviews the evolving specialty pharmacy industry and discusses emerging challenges from direct distribution models that bypass wholesale distribution.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

While not stated in the Temporary Rule, telemedicine prescribers and pharmacies should ensure that state laws permit telemedicine prescribing, and should ensure they hold necessary licenses in accordance with state law, especially if prescribing or dispensing across state lines.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, the agency had received over 43,500 comments. 53,688 (Aug. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,767 (Aug.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. What is drug compounding?

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). d/b/a Drug Channels Institute. pharmaceutical distribution industry.

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Drug Channels

OCTOBER 11, 2022

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S. We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.

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Drug Channels

OCTOBER 19, 2020

Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Visit www.informaconnect.com/trade-channel for further details and to register.

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Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021!

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FDA Law Blog: Biosimilars

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a)(8). Section II at 2.

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The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. At some hospitals, it can take up to 30 minutes to get a status epilepticus drug from the pharmacy to the point of care in the ER to treat a patient.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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FDA Law Blog: Biosimilars

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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Drug Channels

OCTOBER 13, 2020

Click here to download a free report overview (including the Table of Contents and a List of Exhibits) New Drug Channels Institute Study Examines Impact of COVID-19 on U.S. Drug Distribution Industry (press release) We’re offering special discounted pricing if you order before October 23, 2020! d/b/a Drug Channels Institute.

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The Pharma Data

MAY 13, 2021

Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice ( Reuters ). Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ). Vaccine waiver talks can make drug firms the heroes, US trade chief says ( Reuters ) ( Law360 ).

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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.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

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The Pharma Data

JANUARY 18, 2021

According to Health Canada, “the information currently available at the Controlled Substances Directorate, 2-bromo-LSD is NOT CONTROLLED under the Schedules to the Controlled Drugs and Substances Act.”. BetterLife’s TD-0148A is one such treatment,” said Ahmad Doroudian, CEO of BetterLife. About BetterLife Pharma Inc. BetterLife Pharma Inc.

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Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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The Pharma Data

JANUARY 13, 2021

Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA. We are excited to attract such top tier talent from the psychedelic drug development community. . NEW YORK , Jan.

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. Under the EUA, inpatient pharmacies in the U.S. Adverse Reactions. BC HCP EUA ISI 28JUL2021.

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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The Pharma Data

NOVEMBER 5, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration , which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. Finally, the IDMC recommends continuation of the outpatient trial without modification. Regeneron is also informing the U.S.

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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.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. None of the SAEs were considered to be related to study drug.

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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). Food and Drug Administration (FDA) in support of an efficacy supplement to the Tyvaso new drug application (sNDA), which we expect to result in revised labeling reflecting the outcome of the INCREASE study.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

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The Pharma Data

DECEMBER 5, 2020

About the Phase 1/2 Dose-escalation Trial REGN5458 monotherapy is being investigated in an open-label, Phase 1/2 dose-escalation trial in patients with R/R multiple myeloma who are at least triple refractory to existing therapeutic options, including proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments.

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