Drug Target Review

JUNE 11, 2025

He holds a master’s degree from University of Salerno in political sciences and marketing. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes. Connect on LinkedIn >> Alessio Zoccoli applies AI for a sustainable future.

Drugs 64

Drugs Clinical Trials Drug Development Pharmaceuticals 64

Drug Channels

OCTOBER 11, 2022

This 2022-23 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. The exhibits appear in all license versions. pharmaceutical distribution industry.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

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

Vaccine Doctors Pharmacy FDA 52

Drug Channels

SEPTEMBER 12, 2023

As always, we have updated all market and industry data with the most current information available. The report also updates our annual analyses of the strategies, market positions, and executive compensation of the three largest companies: AmerisourceBergen (Cencora), Cardinal Health, and McKesson. d/b/a Drug Channels Institute.

Pharmaceuticals 40

Pharmaceuticals Pharmacy Biosimilars 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 function of the adjuvant is to market the body’s immune reaction. Varadarajan is co-founder of AuraVax Therapeutics Inc.,

Vaccine 52

Vaccine Disease Immune Response Virus 52

The Pharma Data

NOVEMBER 1, 2020

“The completion of this strategic partnership with Walgreens Boots Alliance enables us to strengthen and secure the future of pharmaceutical distribution in the German market,” said Kevin Kettler, chairman of the management board and president McKesson International. Used under license. © 2020, Fortune Media IP Limited. About McKesson.

Pharmacy 40

Pharmacy Community Pharmacies Pharmaceuticals Licensing 40

FDA Law Blog: Biosimilars

MARCH 4, 2024

blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. The notification requirements apply to each individual manufacturer regardless of market share, the number of competitors making therapeutically equivalent products, or the amount of product in distribution.

FDA 59

FDA Production Marketing Drugs 59

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

FDA 52

FDA FDA Approval Licensing Licensing 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

JANUARY 13, 2021

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

Clinical Trials 52

Clinical Trials FDA Trials Production 52

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 (..)

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 30, 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 (..)

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Read AgencyIQ analysis of a recent listening session on the topic here. ].

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

OCTOBER 27, 2020

The decrease in Adcirca revenues was driven by continued erosion of market share due to generic competition. Sales and marketing. License-related fees (5). License-related fees (5). Cost of product sales. .

FDA 40

FDA Production Licensing Licensing 40

The Pharma Data

DECEMBER 17, 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 (..)

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

DECEMBER 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 (..)

Production 40

Production Trials Treatment Disease 40

The Pharma Data

OCTOBER 28, 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 (..)

Virus 40

Virus Trials Clinical Trials Production 40

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 96

Pharmacy Specialty Pharmacies Biosimilars Licensing 96

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. 1395w-114c(b)(4)(B)(i). had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

NOVEMBER 8, 2020

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. This is an important milestone for Sedor Pharmaceuticals and opens a significant global market for the company. Both products were licensed from Ligand Pharmaceuticals.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 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 10, 2023

No other report on the market today offers the depth, insight and analysis into these channels This 2023-24 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson.

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.

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

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date. In most states, this defers to the USP recommendation.

Science 40

Science FDA Production Packaging 40

The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 12, 2021

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 (..)

Government 52

Government Hospitals Virus Clinical Trials 52

Drug Channels

OCTOBER 13, 2020

The 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors —our 11th edition—remains the most comprehensive resource for analyzing the pharmaceutical distribution industry’s economics, market structure, growth rates, forces of change, and interactions with the U.S. healthcare system. There are an astonishing 482 (!)

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Pharmacy 40

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. R&D: Up-front payments related to license and collaboration agreements. (85). Non-GAAP net income per share – diluted (1). $. In millions).

Production 40

Production FDA Trials FDA Approval 40

The Pharma Data

NOVEMBER 20, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. A Marketing Authorization Application (MAA) has been accepted and is under review by the European Medicines Agency (EMA). Outside the U.S., Food and Drug Administration (FDA).

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 21, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

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. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

Agency IQ

FEBRUARY 12, 2024

This is a topic that seems highly related to a recent report from the Reagan-Udall Foundation for the FDA focused on “enhancing post-market evidence generation for medical products” that calls for a “learning health care system.” CDER’s 2024 guidance agenda: Title Category New or repeated from previous agenda?

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Drugs 59

Drugs Regulations Vaccine Government 59

Agency IQ

FEBRUARY 15, 2024

Priority A List. CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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FDA Science Biosimilars Clinical Trials 40