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

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. pharmacies and personal imports from India can be safe as well.

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Pharmacy International Government FDA Approval 84

Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” Here’s one example and you can be the judge.

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Pharmacy Licensing Licensing Online Pharmacies 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.

Pharmacy 52

Pharmacy Licensing Licensing Pharmaceuticals 52

Drug Channels

SEPTEMBER 12, 2023

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

Pharmaceuticals 40

Pharmaceuticals Pharmacy Biosimilars Licensing 40

Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. Instead, it had everything to do with licensed U.S. pharmacies and wholesalers allegedly flouting the rules.

Pharmacy 40

Pharmacy Drugs Licensing Licensing 40

Policy Prescription

MARCH 11, 2022

It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs. supply chain.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

The Pharma Data

NOVEMBER 1, 2020

It is a very exciting step for our Pharmaceutical Wholesale Division and a unique chance for us to further develop innovative services to manufacturers and pharmacists in Germany.”. Together, we look forward to delivering a successful model of operations to benefit the German healthcare ecosystem of patients, pharmacies and manufacturers.”.

Pharmacy 40

Pharmacy Community Pharmacies Pharmaceuticals Licensing 40

The Pharma Data

SEPTEMBER 30, 2021

” To solve those problems, Varadarajan collaborated with Xinli Liu, professor of pharmaceutics at the UH College of Pharmacy, and an expert in nanoparticle delivery. the corporate has an exclusive license agreement with UH with reference to the property covering intranasal vaccines and STING agonist technologies.

Vaccine 52

Vaccine Disease Immune Response Virus 52

The Pharma Data

MARCH 26, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

Vaccine 52

Vaccine Doctors Pharmacy FDA 52

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

FDA 59

FDA Production Marketing Drugs 59

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. NEW YORK , Jan.

Clinical Trials 52

Clinical Trials FDA Trials Production 52

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 40

FDA Pharmacy Drugs Production 40

The Pharma Data

NOVEMBER 5, 2020

Forward-Looking Statements and Use of Digital Media This statement includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking (..)

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 30, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , 30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. Contacts: Media Relations Alexandra Bowie Tel: +1 (914) 847-3407 alexandra.bowie@regeneron.com. View original content: [link].

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. 6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. Source link.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. “The investigational cocktail is now available to indicated high-risk U.S. Source link.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

OCTOBER 28, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. Investor Relations Mark Hudson Tel: +1 (914) 847-3482 mark.hudson@regeneron.com . .

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA 40

FDA Production Licensing Licensing 40

Policy Prescription

DECEMBER 22, 2021

Drug companies and big chain pharmacies don’t want the competition of lower drug prices offered by international online pharmacies because it means lower profits. They want the FDA to shut down those sites, but, it seems, under current law, the international online pharmacies used to facilitate importation are not illegal.

Online Pharmacies 52

Online Pharmacies Pharmacy Drugs International 52

DrugBank

NOVEMBER 7, 2023

The healthcare community can license ASHP data for use in new or existing software, databases, or websites in formats specific to organisational needs. For over 80 years, ASHP has championed innovation in pharmacy practice, advanced education and professional development, and served as a steadfast advocate for members and patients.

Pharmacy 105

Pharmacy Community Pharmacies Pharmaceutical Companies Packaging 105

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. state pharmaceutical assistance programs). 1395w-114c(b)(4)(B)(i).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

NOVEMBER 8, 2020

PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. 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. About Sedor Pharmaceuticals, LLC. About Sesquient.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. we analyze the IRA’s likely consequences for wholesalers and the overall pharmaceutical business. and Section 6.4.3.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia. 4 But the same barriers still exist today.

Therapies 137

Therapies Virus DNA Clinical Trials 137

Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

Science 52

Science Specialty Pharmacies Pharmacy Licensing 52

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations 40

Regulations FDA Science Production 40

Drug Channels

OCTOBER 13, 2020

I am pleased to announce our new 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors is the only resource of its kind available anywhere. healthcare system. FOUR FUN FACTS.

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Pharmacy 40

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 40

Science FDA Production Packaging 40

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 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 12, 2021

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. NASDAQ: REGN ) today announced that the U.S.

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50%

Production 40

Production FDA Trials FDA Approval 40

The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. TARRYTOWN, N.Y., Food and Drug Administration (FDA).

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. SOURCE Regeneron Pharmaceuticals, Inc. government allocation program. Investor Relations Mark Hudson Tel: +1 (914) 847-3482 mark.hudson@regeneron.com .

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. 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. SOURCE Regeneron Pharmaceuticals, Inc. Contacts: Media Relations media@regeneron.com .

Hospitals 52

Hospitals Trials Clinical Trials Production 52