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

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 86

Pharmacy Community Pharmacies Packaging Pharmaceutical Companies 86

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

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. 72,694, 72,703 (Dec.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

Policy Prescription

MAY 28, 2021

The NeedyMeds host then asks Mr.Safdar: “Are there any pharmacies in Canada that are safe to purchase brand name drugs from…? and licensed by your state board of pharmacy.” They are wondering if there’s a way to determine the quality of those mail-order pharmacies. state-licensed board of pharmacy licensed pharmacy.”.

Pharmacy 52

Pharmacy Online Pharmacies Licensing Licensing 52

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

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations. The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Drug Channels

OCTOBER 10, 2023

reviews the evolving specialty pharmacy industry and discusses emerging challenges from direct distribution models that bypass wholesale distribution. We provide updated, expanded, and reorganized data about the following markets: Pharmacy services administrative organizations (Section 2.2.4.) and Section 6.4.3. A new Section 6.2.2.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Drug Channels

OCTOBER 11, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

SEPTEMBER 12, 2023

The notable new material in this 2023-24 edition includes new data about commercial pricing and reimbursement for provider-administered biosimilars as well as updated, expanded, and reorganized data about pharmacy services administrative organizations and group purchasing organizations for small pharmacies and physician practices.

Pharmaceuticals 52

Pharmaceuticals Pharmacy Biosimilars Licensing 52

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 International Drugs 52

Drug Channels

OCTOBER 5, 2021

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more. There are an astonishing 537 (!)

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

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

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

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

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.

Nurses 52

Nurses Doctors Vaccine Pharmacy 52

The Pharma Data

NOVEMBER 1, 2020

Together, we look forward to delivering a successful model of operations to benefit the German healthcare ecosystem of patients, pharmacies and manufacturers.”. The company has more than 100 years of trusted healthcare heritage and innovation in community pharmacy and pharmaceutical wholesaling. . *© Used under license.

Pharmacy 40

Pharmacy Community Pharmacies Pharmaceuticals Licensing 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. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

The Pharma Data

JANUARY 5, 2021

Besides giving telemedicine a boost, the pandemic has also fostered the rise of innovative medical services, everything from getting prescriptions by mail to drive-through virus testing and pharmacy-based vaccinations. Pharmacies also fill gaps. In April, HHS allowed licensed pharmacists to test patients for COVID-19.

Doctors 52

Doctors Pharmacy Vaccine Licensing 52

Drug Channels

OCTOBER 13, 2020

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more. There are an astonishing 482 (!)

Pharmaceuticals 52

Pharmaceuticals Licensing Licensing Pharmacy 52

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 Licensing 52

Drug Discovery World

JUNE 12, 2024

In clinical trials, Moderna’s combination vaccine elicited higher immune responses against influenza (flu) virus and SARS-CoV-2 than licensed flu and Covid-19 vaccines in adults 50 years and older. The Phase III trial investigated mRNA-1083, an investigational combination vaccine against influenza and Covid-19.

Vaccine 147

Vaccine Immune Response Clinical Trials Licensing 147

FDA Law Blog: Biosimilars

MARCH 4, 2024

By actively updating the information related to shortages, FDA intends to allow the public and prescribers to develop alternative treatment plans before learning a prescription cannot be filled at the pharmacy when there is a supply issue.

FDA 59

FDA Production Marketing Pharmacy 59

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 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 ).

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation?

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Drug Target Review

JULY 19, 2023

Translating these insights into a licensed vaccine (RTS,S, made by GlaxoSmithKline) took nearly five decades – a glacial pace compared to the recent COVID-19 vaccines. References: SoCal pharmacies scrambling for ultra-cold freezers for pfizer COVID vaccine storage [Internet]. ABC7 Los Angeles. Available from: [link] Project B.

Vaccine 96

Vaccine Engineering Disease Virus 96

The Pharma Data

JANUARY 18, 2021

We believe that there is a great need for novel non-hallucinogenic treatments of mental disorders that can be dispensed at the pharmacy level and safely administered at home. BetterLife will not face the significant regulatory hurdles during the development process of TD-0148A that other psychedelic products will have to overcome.

Pharmacy 40

Pharmacy Regulations Compliance Licensing 40

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

The Pharma Data

JULY 29, 2021

Under the EUA, inpatient pharmacies in the U.S. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. may order 1-mg and 2-mg tablets of baricitinib through Lilly’s authorized distributors.

Hospitals 52

Hospitals FDA Laboratories Licensing 52

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

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.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (“FDA”) will grant an Emergency Use Authorization (“EUA”) for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such (..)

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration (“FDA”) with respect to a potential Emergency Use Authorization (“EUA”) for REGN-COV2, and possible regulatory approval of REGN-COV2; whether the FDA will grant an EUA for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; (..)

Hospitals 52

Hospitals Virus Production Clinical Trials 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 Production Drugs 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

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. Merck will not receive any milestone payments for the development of lonafarnib for the treatment of Progeria, and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52