FDA Law Blog

JULY 20, 2021

The new rule applies not only to product labeling, but to any “mail order catalog” or “mail order promotional material” that includes a seal, mark, tag, or stamp that labels a product as having been made in the United States. or the Egg Products Inspection Act. The effective date of the rule is Aug. 13, 2021.

Production 76

Production Sales Regulation Packaging 76

Camargo

AUGUST 22, 2021

A final binding guidance published April 2017, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications required that electronic submissions be formatted according to eCTD submission standards and defined technical rejection criteria.

Containment 190

Containment Bioavailability Cosmetics Packaging 190

XTalks

DECEMBER 13, 2023

While Lyfgenia delivers a functional copy of hemoglobin A to replace the abnormal one in hematopoietic (blood) stem cells via a lentiviral vector, Casgevy edits the HBB gene using CRISPR technology to increase the production of fetal hemoglobin in blood stem cells. Vertex-CRISPR’s Casgevy has a US list price of $2.2

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

pharmaphorum

JANUARY 11, 2021

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. million price tag. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8

Gene Therapy 58

Gene Therapy Gene Genetic Disease Manufacturing 58

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

AUGUST 19, 2022

The road to Zynteglo’s approval was a bit rocky and included an FDA delay (the most recent in June) over production test concerns. Zynteglo’s hefty price tag of $2.8 Any gene therapy company you can name off the top of your head … they’re all facing the same problems around manufacturing and [production controls].”.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

AUGUST 25, 2021

But now that restrictions are loosening, more and more retail settings are offering food samples once again — an encouraging sign for smaller brands that rely on it to get its products into the hands of consumers. . But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. .

Branding 98

Branding Marketing Nurses Production 98

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. It has already initiated production planning for potentially hundreds of millions of vaccine doses in 2021.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. About Trimer-Tag© Technology.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

Production 264

Production Pharma Production Pharma Companies Drugs 264

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

Branding 109

Branding Marketing Pharma Companies Life Science 109

XTalks

OCTOBER 28, 2021

A recent lifecycle assessment Perfect Day’s protein production found that “if US consumers switched entirely to Perfect Day whey protein, this would save up to 246 million tons of CO2e emissions, which is the equivalent of up to 28 million homes’ energy use for one year.”. percent from 2019 to 2025.

Protein 98

Protein Packaging Packaging DNA 98

Intouch Solutions

JULY 27, 2021

We can also expect other health plans and pharmacy benefit managers (PBMs) to make this approach part of their own toolkits if it proves to be successful. The majority of new products coming to market are specialty drugs targeting rare diseases and new breakthrough approaches to cancer treatment – but innovation comes with large price tags.

Drugs 52

Drugs Marketing Vaccination Vaccine 52

Drug Discovery World

MAY 22, 2023

But are these price tags a barrier to access? From private plans to government programmes, there are workable systems that support CGTs, proven by MediCare’s support of CAR-T and the UK’s National Health Service coverage. million per dose. It is imperative that these payment processes are supported to expand access.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

pharmaphorum

DECEMBER 2, 2020

The company’s first product, a palatable anti-parasitic drug, made to taste like toffee, united Pfizer’s skills as a chemist with Erhart’s training as a confectioner. Like their competitor Squibb, the sudden need for enormous quantities of painkillers and antiseptics for the Union armies provided a great scope to expand production.

Sales 127

Sales Production Drugs Marketing 127

Intouch Solutions

APRIL 11, 2024

Manufacturing : Improved operations, efficiency, and production costs. Generating “data-driven” editorial plans. Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

XTalks

FEBRUARY 27, 2024

Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” The company had originally planned to file its application in 2020 but that was thwarted when the FDA questioned the assays used to measure the potency of each therapy dose.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

OCTOBER 12, 2022

K trans is a useful endpoint for assessing the blood supply to a target lesion because it is related to blood flow and the endothelial permeability-surface area product. This provides one potential piece of evidence to support moving forward with the clinical development plans for this drug.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

Delveinsight

DECEMBER 3, 2020

A&E’s portfolio covers a complete line of sternum closure devices, comprising of suture, fixation and cable systems, plus a range of disposable products such as pacing wires and punch tools utilized for tissue biopsies. Merck chooses TriNKET cancer immunotherapy program. Bayer creates cell and gene therapy platform.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

APRIL 6, 2021

Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. Food production was also heavily hit due to safety restrictions to create safer co-working environments such as refrigerated work environments in the meat and fresh produce industries.”. The same went for meat and dairy.

Production 104

Production Sales Vaccination Vaccine 104

Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

Drugs 61

Drugs FDA Approval Manufacturing Pharmacy 61

XTalks

MARCH 22, 2023

And in 2020, AbbVie bought out Allergan for $63 billion, four years after Allergan and Pfizer abandoned their planned megamerger after a years-long will-they-or-won’t-they courtship. In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

Delveinsight

JULY 22, 2020

Since the data is collected over a very long period, it can bring new insight and information which will help understand the functioning of the body and also ensures better medical treatments and productivity. The hospital inventory is equipped with tagged sensors. Services In Remote Area. Medical Equipment Tracking.

Doctors 59

Doctors Doctor Marketing Production 59

Cloudbyz

JUNE 1, 2023

These features help streamline business processes, increase productivity, ensure consistency, and enhance overall customer service. This ensures a more personalized, intuitive, and user-friendly experience, helping to increase user adoption and productivity. It allows users to create, discuss, and organize their work from any device.

Compliance 79

Compliance Development Branding Production 79

The Pharma Data

NOVEMBER 15, 2020

In addition, this will meet Clover’s Phase 2/3 clinical production plan and commercial readiness once its vaccine candidate is approved. ” Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag © technology.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Intouch Solutions

AUGUST 25, 2021

Situation With the upcoming iOS 15 launch planned for September, Apple is adding to its privacy measures with mail privacy protection software enhancements. We also know, in the Americas, the top channel preference to drive awareness and product updates among HCPs is marketing emails at 72%. The result? ©Intouch Group 2021.

Marketing 52

Marketing Regulation Engineer Branding 52

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Having pre-planned gating and analysis strategies is essential to avoid compensation issues and ensure unbiased data analysis. Kenta Yamamoto received his Ph.D.

Reagent 52

Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Hospital products, which grew 10% operationally to $2.3 This guidance may be adjusted in the future as additional contracts are executed.

Vaccination 40

Vaccination Vaccine Production Sales 40

The Pharma Data

MAY 5, 2021

CureVac says well on track to request vaccine approval as planned ( Reuters ) ( NYT ). FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ). Esker, a new biotech startup, launches with plans to make targeted immune drugs ( BioPharma Dive ). Medtech.

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

Pharmaceutical Technology

MARCH 17, 2023

Watt explained that these agreements “aim to help mitigate the risk of including high-cost drugs into reimbursement lists and healthcare plans”. In some cases, she said, “[drug] innovation would have been otherwise hindered by their price tag alone”. Click here to watch this webinar and access the presentation.

Marketing 257

Marketing Drugs Research Analyst Manufacturing 257

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities. compared to a 5.1%

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities. compared to a 5.1%

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246

Pharma Marketing Network

JUNE 8, 2020

Dave (HR): Yeah, I mean really everything we’re doing you know is about overturning the devastating effects of the status quo health plans. So, it’s very easy for a $100,000 cancer case to turn into a half a million or a million-dollar cancer case if it’s not well diagnosed and there’s not a good treatment plan.

HR 40

HR Marketing Doctors Doctor 40