Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

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Policy Prescription

MAY 28, 2021

For the past decade, I’ve written extensively about my view that pharma-funded organizations and initiatives are responsible for misleading Americans about the safety of buying more affordable prescription drugs over the Internet for import from Canada and other countries. Here’s one example and you can be the judge.

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Pharmacy Online Pharmacies Licensing Licensing 52

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 86

Pharmacy Community Pharmacies Packaging Pharmaceutical Companies 86

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.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

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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Pharmacy Licensing Licensing Pharmaceuticals 52

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.

Licensing 52

Licensing Licensing Pharmacy FDA 52

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.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. First, drug prices in the U.S. He points to “a mere 1.5%

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Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients.

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40

Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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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).

Pharmacy 52

Pharmacy Regulations Licensing Licensing 52

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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Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

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.

Online Pharmacies 52

Online Pharmacies Pharmacy International Drugs 52

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?

FDA 40

FDA Pharmacy Production Drugs 40

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.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

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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Policy Prescription

MARCH 11, 2022

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs. supply chain.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

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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Pharmaceuticals Biosimilars Licensing Licensing 75

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.

Specialty Pharmacies 52

Specialty Pharmacies Science Pharmacy Licensing 52

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.

FDA 52

FDA FDA Approval Licensing Licensing 52

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.,

Compliance 105

Compliance Pharmacy Drugs Licensing 105

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.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

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.

Drugs 59

Drugs Regulations Government Vaccine 59

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 Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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Clinical Trials Biosimilars Pharma Companies Production 130

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.

Pharmaceuticals 52

Pharmaceuticals Licensing Licensing Pharmacy 52

Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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Clinical Trials Treatment Trials Small Molecule 52

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.

Therapies 138

Therapies DNA Virus Clinical Trials 138

The Pharma Data

MARCH 26, 2021

It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

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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.

Science 40

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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 ).

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Drug Target Review

JULY 19, 2023

5 Each of these investigational new drugs have the following appealing features: They are shelf-stable at ambient temperatures They can be self-administered without injection They are inexpensive to manufacture at scales large enough to meet demand for highly prevalent, global diseases. High impact drugs at dirt cheap cost [Internet].

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Vaccine Engineering Disease Virus 96

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.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

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.

Pharmacy 40

Pharmacy Regulations Compliance Licensing 40

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. ]

Regulations 40

Regulations FDA Science Production 40

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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Clinical Trials FDA Trials Production 52