Pharmaceutical Technology

DECEMBER 12, 2022

An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma.

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Development Gene Therapy Clinical Trials Clinical Trials 264

pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. Emphasising multiregional trials. Single-region concerns.

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Clinical Trials Clinical Trials Trials Development 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

Contract marketing companies offer various marketing services that connect suitable strategies with customers at different points in the product lifecycle, helping to increase the customer base and thus revenue. Finding the top API chemical companies in contract marketing.

Marketing 100

Marketing Manufacturing Generic Drugs Containment 100

Crucial Data Soutions

DECEMBER 15, 2020

Someday, clinical and post-market research will be 100 percent remote. A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The research team accomplishes a rapid trial start-up with the platform’s efficient study design tools. It’s winter 2020 and COVID-19 is in full swing.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Clinical Research 105

Pharmaceutical Technology

OCTOBER 26, 2022

The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.

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Gene Therapy Gene Marketing Manufacturing 130

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Gene Therapy Gene Trials Clinical Trials 264

Pharma Mirror

FEBRUARY 18, 2022

From research to clinical trials, to go-to-market, drug makers are constantly seeking out new drug technologies and approaches to treat everyday illnesses and to end global pandemics. But the vials and containers that deliver these drugs haven’t evolved at nearly the same rate.

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Packaging Packaging Drugs Clinical Trials 130

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Exosome-Based Liquid Biopsy in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Pharmaceutical Technology

SEPTEMBER 8, 2022

Find the leading API biologics companies in contract marketing. Pharmaceutical Technology has listed some of the top API biologics companies in contract marketing based on our intel, insights and decades-long experience in the sector.

Gene 100

Gene Marketing Vaccine Vaccination 100

Camargo

SEPTEMBER 14, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. In this second installment, we compare applications for conducting clinical studies, expedited programs, pediatric plans, and labeling in the US and EU markets.

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Clinical Trials Clinical Trials Medicine Production 144

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

Advarra

DECEMBER 17, 2024

For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

Clinical Research 98

Clinical Research Research Trials Clinical Trials 98

Delveinsight

JULY 26, 2021

However, antibiotics are the only available treatment options in the Uncomplicated Urinary Tract Infections market to cater to such a large patient pool. Some of the most commonly prescribed antibiotics in the Uncomplicated Urinary Tract Infection therapy market include the combination drug trimethoprim and sulfamethoxazole, trimethoprim, ?-lactams,

Marketing 93

Marketing Bacteria Development Vaccination 93

Pharmaceutical Technology

JANUARY 24, 2023

Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. Polyrizon Ltd., million in gross proceeds. The IPO, priced at $4.38 Polyrizon Ltd.

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

World of DTC Marketing

NOVEMBER 27, 2020

Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.

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Vaccine Vaccination Pharma Companies Trials 208

World of DTC Marketing

JUNE 10, 2021

If the message is promotional, there is a high likelihood you will get a poor response, but if the message contains important updates, it is more likely to be read. On the other hand, we did make a thought elder, who worked on clinical trials of a cancer drug, to take questions from other physicians about those clinical trials.

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Doctor Doctors Clinical Trials Clinical Trials 143

Delveinsight

OCTOBER 1, 2021

There are several therapies in the market to address the Myasthenia Gravis burden, and many companies are still working on their drug candidates to cope with Myasthenia Gravis. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Myasthenia Gravis Approved Therapies.

Marketing 85

Marketing Antibody Drugs Sales 85

Pfizer

SEPTEMBER 16, 2022

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

Marketing 75

Marketing Vaccine Vaccination Clinical Trials 75

World of DTC Marketing

FEBRUARY 9, 2021

In clinical trials, how many people experienced a listed side effect? Email is still a great digital marketing tool, and our audiences felt that if the email contained updated health information and tips for living with certain health problems, they would open and read it. First impressions are 94% design-related.

Drugs 180

Drugs Pharma Production Doctor Doctors 180

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

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Development Bioequivalency Generic Drugs Production 242

XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. The FDA’s approval of Posluma was based on two Phase III clinical trials, LIGHTHOUSE and SPOTLIGHT. billion by 2030, according to a report by Global Market Insights.

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Marketing 96

Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

Marketing 65

Marketing Drugs Antibody Compliance 65

The Pharma Data

JANUARY 10, 2021

Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements. For additional information please visit www.aslanpharma.com.

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Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

MAY 24, 2021

This article appears in out digital magazine Deep Dive: Market Access 2021. Having gone from being an innovation buzzword to becoming a core part of drug assessment processes it offers health technology assessment (HTA) bodies a way to assess the value and impact of drugs outside of an artificial clinical trial setting.

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Drugs Clinical Trials Clinical Trials Doctor 83

The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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Clinical Trials Clinical Trials Trials Antibody 52

Pharmaceutical Technology

FEBRUARY 1, 2023

However, caution must be taken, especially while bringing new mAbs to market, to avoid the potentially serious consequences of inducing novel viral mutations and further antibody-resistant strains of RSV. Cases of palivizumab-resistant RSV strains have been documented as early as 2010, roughly 12 years after the mAb entered the market.

Vaccine 162

Vaccine Vaccination Antibody Protein 162

Pharma Marketing Network

FEBRUARY 5, 2025

Table of Contents Sr# Headings 1 Understanding Pharmaceutical Market Access 2 Challenges in Pharmaceutical Market Access 3 Key Strategies for Market Access Success 4 Emerging Trends Shaping Market Access Understanding Pharmaceutical Market Access Bringing a new drug to market is only part of the battle.

Marketing 52

Marketing Pharma Companies Drugs Regulation 52

Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 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. Disclosure Notice The information contained in this statement is as of January 27, 2023.

Marketing 75

Marketing Production Drugs Licensing 75

pharmaphorum

DECEMBER 14, 2022

For years, Jazz Pharmaceuticals has dominated the market in treating narcolepsy with cataplexy. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. Monopoly money.

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FDA Approval Marketing Containment Drugs 116

Pharma in Brief

OCTOBER 20, 2021

In the context of addressing Health Canada’s requirements for approvability, the submission was withdrawn, refiled and a market authorization was issued. Merck’s application for judicial review was granted, the Minister’s decision was set aside and the application remitted to the Minister for redetermination.

Production 98

Production Clinical Trials Clinical Trials Containment 98

pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

Regulation 105

Regulation Vaccine Vaccination Protein 105

Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. FDA-Issued Guidances Offer Clarification on PREA, QIDP Designation, Post-Marketing Requirements, and More.

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XTalks

SEPTEMBER 28, 2023

XTALKS WEBINAR: A Step-by-Step Approach to eSource in Clinical Trials Live and On-Demand: Thursday, October 26, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to adopt an incremental approach to eSource (EHR to EDC integration) across multiple trial scenarios to overcome real and perceived challenges.

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . 21 CFR 312.3(b)

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52