Drug Channels

OCTOBER 5, 2021

This 2021-22 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. reviews AmerisourceBergen’s entry into the European distribution market. (We Section 4.4. Section 7.4.4.

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

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?

Specialty Pharmacies 52

Specialty Pharmacies Science Pharmacy Licensing 52

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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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. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

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.

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FDA Production Marketing Pharmacy 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)

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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

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

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 52

Pharmaceuticals Licensing Licensing Pharmacy 52

The Pharma Data

MAY 13, 2021

‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs ( STAT ). Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). Pharma & Biotech. ICER, Accelerated Approval And The Payer Voice At The US FDA ( Pink Sheet ).

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FDA Approval FDA Vaccine Pharmacy 52

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

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 Regulations Therapies 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

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

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

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 Production Drugs 40

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 Pharmaceuticals 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

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

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

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 52

Production FDA FDA Approval Trials 52

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 Production 52

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

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 Packaging Production 40

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).

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Compliance Pharmacy Drugs Licensing 105

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

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.

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Regulations FDA Science Production 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 121

Therapies Virus DNA Clinical Trials 121

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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FDA Science Regulations Production 40

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. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 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 Government Vaccine 59

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

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.

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FDA Science Regulations Production 40

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.

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FDA Clinical Trials Hospitals Government 40

The Pharma Data

JANUARY 27, 2021

The rules, drafted under the Public Readiness and Emergency Preparedness Act, will also be adapted to allow licensed doctors, nurses and health practitioners to administer shots across state lines, Zients said. Arranging to supply vaccines directly to pharmacies. Standing up mobile vaccination clinics to reach under-served communities.

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Nurses Doctors Vaccine Pharmacy 52