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 Draft Guidance III.B.2(e)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

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. In total, 47% of participants were male and 53% were female. .

Virus 40

Virus Trials Clinical Trials Production 40

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

The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

Hospitals 52

Hospitals Trials Clinical Trials 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. Sedor Pharmaceuticals, LLC identifies, acquires and develops acute care pharmaceutical assets for commercial licensing. Both products were licensed from Ligand Pharmaceuticals.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

The Pharma Data

JANUARY 12, 2021

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. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D., In the U.S.

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 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

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 131

Therapies Virus DNA Clinical Trials 131

Agency IQ

JANUARY 26, 2024

What happens when a drug is not stored in its original container or within a licensed facility? All of the evidence discussed thus far pertains to drugs that have been stored in ideal conditions and within the original container by a licensed facility. Enter the beyond-use date. In most states, this defers to the USP recommendation.

Science 40

Science FDA Production Packaging 40

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

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D., Limitations of Authorized Use.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

NOVEMBER 5, 2020

. “Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production 40

Production Trials FDA FDA Approval 40

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 40

Pharmaceuticals Licensing Licensing Pharmacy 40

The Pharma Data

NOVEMBER 20, 2020

The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Four (8%) patients reported severe diarrhea.

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

JULY 29, 2021

The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Under the EUA, inpatient pharmacies in the U.S. Wesley Ely, M.D.,

Hospitals 52

Hospitals FDA Laboratories Treatment 52

Drug Channels

MARCH 18, 2025

Pharmacies and Pharmacy Benefit Managers is now available for purchase and immediate download. Pharmacies and PBMs, Examining $683 Billion Market Review pricing/license options and download the full 2025 report Order before March 31, 2025 to receive special discounted pricing! Pharmacies and Pharmacy Benefit Managers.

Pharmacy 52

Pharmacy Specialty Pharmacies 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. Arranging to supply vaccines directly to pharmacies. Standing up mobile vaccination clinics to reach under-served communities.

Nurses 52

Nurses Doctors Vaccine Pharmacy 52

Drug Target Review

FEBRUARY 11, 2025

The enormous amount of data generated in a short time by NGS equipment has led to the widespread adoption of clinical genomics in both industrial and hospital settings. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59

Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. UPMC Pinnacle Hospitals , 283 A.3d Presence Center & Suburban Hospitals Network , 191 N.E.3d.

Vaccine 59

Vaccine Pharmacy Hospitals Licensing 59

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. In at least the short term, a popular pain reliever would have to be removed from pharmacies. Wyeth Laboratories, Inc. ,

FDA 59

FDA FDA Approval Testimonials Vaccine 59