pharmaphorum

MAY 26, 2022

In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

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Clinical Trials Clinical Trials Trials Medicine 131

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. • What does it mean for you?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

FEBRUARY 3, 2023

When you consider the existing challenges limiting the upstream production of viral vectors, this figure becomes even more alarming. We saw a huge potential for these stable cell lines; it’s really the most logical and efficient way to scale up AAV production. So, we set out to solve some of the problems,” she explains.

Genome 244

Genome Genomics Medicine Gene Therapy 244

pharmaphorum

MAY 27, 2022

As the shift to home working proliferated during the pandemic, work became decentralised – and many businesses were able to be productive with a workforce at home. You can read part one of this article here. Teams and Zoom became the backbone of communication and firms embraced new ways of working. About the interviewees.

Clinical Trials 78

Clinical Trials Clinical Trials Trials Packaging 78

FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. Nor is it unusual for FDA to give FDA a deadline (which is often missed).

Regulation 52

Regulation Licensing Licensing Sales 52

FDA Law Blog

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Gene Therapy 119

Gene Therapy Gene FDA Approval Production 119

Creogenic Pharma

APRIL 15, 2023

Understanding the company’s products, strengths, weaknesses, competition, and the specific needs of potential franchisee distributors is crucial for successfully converting inquiries into business opportunities. Theoretical promotional inputs which help guide your doctors for product promotions. Are You a Retailer ? Distributor

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Production Sales Doctors Doctor 40

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? At what point does the drug substance become a drug product?

Packaging 52

Packaging Packaging Drugs Containment 52

Pharmacy Checkers

JANUARY 10, 2020

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. FDA and Alipza by the United Kingdom Medical and Health Product Regulatory Authority. FDA: PIERRE FABRE MEDICAMENT PRODUCTION.

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FDA Approval Branding Pharmacy Manufacturing 62

Pfizer

APRIL 26, 2023

We’ve pioneered solutions to distribution and storage requirements In the last few months alone, Pfizer has developed cutting-edge packaging and storage solutions to meet the needs of the varied locations that will be distributing the vaccine - whether they are in a major cites or rural towns.

Vaccination 52

Vaccination Vaccine Manufacturing Containment 52

FDA Law Blog

JUNE 27, 2021

Ensure DEA registrations and state licenses are current and active and copies maintained in an easily accessible file. Maintain controlled substances in secure areas at all times except during receiving, processing, packaging, labelling or conveying to the secure loading area. Ensure past deficiencies have been remedied.

Drugs 80

Drugs Licensing Licensing Regulation 80

Drug Discovery World

MARCH 29, 2023

The review builds on several data sets, including large IQVIA/MIDAS data sets of products authorised between 2002 and 2020. They explain that a number of studies have demonstrated how incentives influence company development and innovation decisions, such as through the industry-standard risk-adjusted Net Present Value (rNPV) model.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com. AUTHORIZED USE The U.S.

Marketing 75

Marketing Production Drugs Licensing 75

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Herbal Products: St. AUTHORIZED USE .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

AUGUST 3, 2021

We are very pleased that our comprehensive nonclinical data package has addressed all issues identified related to DRG toxicity and the FDA has reached the decision that we may proceed with our OAV-101 IT clinical trial program and initiate the STEER trial,” said Shephard Mpofu, M.D., SVP, Chief Medical Officer, Novartis Gene Therapies.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. J)(2) Waiver authority. for drug safety.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

Drug Discovery World

SEPTEMBER 26, 2022

Other benefits that come with this approach include an already established safety profile for the selected drug and readily available product and manufacturing supply chains. Improvements in technology and changes to worldwide regulations in life sciences has led to an increase in the availability of clinical data. Global efforts .

Drugs 52

Drugs Genome Genomics Clinical Trials 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. and the EU are very similar.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS. FIRST HALF PRODUCT REVENUE HIGHLIGHTS.

Production 52

Production Branding Marketing Licensing 52

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Herbal Products: St. AUTHORIZED USE.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Herbal Products: St. FDA Emergency Use Authorization Statement.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

The Pharma Data

OCTOBER 27, 2020

patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. NexoBrid is currently an investigational product in the United States. On June 29, 2020, a biological license application (BLA) was submitted to the U.S.

Production 40

Production Development Clinical Trials Clinical Trials 40

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Our Commitment to Access. AUTHORIZED USE.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

OCTOBER 14, 2020

Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. 1 Noyce RS, et al. 2018) PLoS One.

Vaccination 40

Vaccination Vaccine Development Medicine 40

The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

Hormones 52

Hormones Insulin Production Packaging 52

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. driven by the write-off of $1.5

Sales 52

Sales Production Antibody Development 52

The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. • Other Products and Contracts and Grants. . $280 — $310.

Production 52

Production Manufacturing Vaccination Vaccine 52

FDA Law Blog

SEPTEMBER 20, 2021

We have seen first-hand the difficult task faced by CBER review staff to keep up with the flood of innovative cell and gene therapy products, as well as the taxing influx of COVID-19 pandemic related applications requiring review resources in both Centers. based upon the anticipated clinical benefit of earlier patient access to the product.”.

Development 52

Development Gene Therapy Production Drugs 52

The Pharma Data

AUGUST 3, 2021

– Revenue from all key products grew in the quarter and 2021 year-to-date. The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021.

Antibody 52

Antibody Sales Production Development 52

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Janssen is the marketing authorization holder for EDURANT ® in the U.S.

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FDA Approval RNA Drugs Containment 52