Drug Discovery World

JANUARY 30, 2024

To achieve this, we need greater collaboration between academia, therapy developers and manufacturing equipment developers.” Stella Vnook , CEO, Likarda , notes that a s more regenerative therapy options come to the market, patients will demand access to the treatments, often using the court system. She

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

Intouch Solutions

APRIL 11, 2024

Precision engagement is a data-driven approach developed for marketing and sales needs. Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. So, what is precision engagement?

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

XTalks

MAY 2, 2024

The 18th Annual Canadian Summit on Food Safety , held last week, brought together industry leaders, regulatory experts and innovators to discuss the current state and future of food safety. Jameson, a food regulatory lawyer and the Canadian Summit on Food Safety’s Chair, talked about AI from a legal perspective. “I

Compliance 110

Compliance Regulation Production Containment 110

pharmaphorum

AUGUST 17, 2020

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. At the moment, it’s really all about earning and maintaining patient and HCP trust when it comes to pharma marketing.”. Virtual connections.

Regulation 87

Regulation Marketing Sales Branding 87

Rethinking Clinical Trials

FEBRUARY 28, 2024

The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. from 2021 to 2026.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Clinical Research 143

pharmaphorum

AUGUST 21, 2022

Auvelity isn’t the first NMDA-targeting antidepressant to reach the market. The biotech hasn’t revealed much information about the reasons for the delay in getting approval, but said in an SEC filing in June this year that it had agreed to “post-marketing commitments” proposed by the FDA, without going into details.

Drugs 96

Drugs FDA Approval Production Marketing 96

Rethinking Clinical Trials

JULY 6, 2023

During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs. This guidance and others in development in other markets act as an important countermeasure to ensuring sustained adoption and implementation of DCTs.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion by 2028. billion in sales in 2028.

Sales 111

Sales Medicine Drugs Marketing 111

pharmaphorum

NOVEMBER 19, 2020

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

FDA Approval 64

FDA Approval Marketing Drugs Clinical Development 64

World of DTC Marketing

JUNE 23, 2021

In my career in healthcare marketing, I have done my best to understand the “science” behind certain health conditions along with how some medications can help. Not to mention the $56,000 annual price tag. When I didn’t understand something, I went to the medical people on the team to gain insights. government.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

XTalks

APRIL 18, 2024

However, Roche has several CSF tests on the market, which include assays in the company’s Elecsys line that are used in conjunction with PET in the diagnosis and monitoring of the disease. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro 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

JULY 25, 2022

.” GSK’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) was the first BCMA-targeting drug to reach the market in 2020, and has since been joined by Carvykti as well as Bristol-Myers Squibb and bluebird bio rival CAR-T therapy Abecma (idecabtagene vicleucel).

Antibody 52

Antibody Medicine Drugs Trials 52

The Pharma Data

MARCH 16, 2022

using SNAP-tag) involves labeling cell proteins with a fluorescent dye, thereby enabling researchers to observe how proteins interact in the living cell and where in the cell they are located. With Spirochrome, he commercialized fluorescent probes for cell biology, while with Covalys, he marketed SNAP-tag and other protein labeling methods.

Protein 52

Protein Scientist Gene Development 52

pharmaphorum

MAY 24, 2021

Modular content is an established practice among digital and content marketers in sectors such as FMCG and retail, who are challenged with increasing demand for more content and creating personalised content to meet the demands of their customers.

Marketing 89

Marketing Branding Sales Life Science 89

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. The company, however, is optimistic and gearing up to find more opportunities to advance in the ALS market.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

XTalks

JUNE 9, 2021

million Alzheimer’s patients in the US, some market goers are apprehensive about the implications this could have for the industry. Aducanumab Controversy and Price Tag. Along with the approval, Biogen also announced the drug’s steep $56,000 per year list price, which is several times higher than what industry analysts were expecting.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

pharmaphorum

NOVEMBER 16, 2022

Only a few years later, bluebird bio’s gene therapy, Zynteglo (betibeglogene autotemcel), was approved in the European market for the treatment of the rare blood disorder, beta thalassaemia. However, with a price tag of €1.58 How to navigate the new climate. At more than $2.1

Gene Therapy 130

Gene Therapy Gene Marketing Development 130

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. As a result, filings and other forms can be completed more quickly and accurately, leading to enhanced quality and regulatory compliance.

Compliance 52

Compliance Life Science Marketing Production 52

FDA Law Blog

JUNE 27, 2023

Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. In addition to Mr. Karst, ten other HP&M Directors were tagged as “Recommended” by WWL: Life Sciences 2023: Ricardo Carvajal Robert A.

Life Science 81

Life Science FDA Approval Drugs Development 81

The Pharma Data

NOVEMBER 15, 2020

Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. SHANGHAI , Nov.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Roots Analysis

SEPTEMBER 13, 2023

These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

Development 40

Development Antibody Protein Drug Delivery Systems 40

XTalks

AUGUST 19, 2022

Register for this free webinar to learn why the agile clinical trial model is a great fit for many rare disease categories, how to navigate the regulatory landscape for agile clinical trials in rare diseases, how to design studies and more. Zynteglo’s hefty price tag of $2.8

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

Rethinking Clinical Trials

AUGUST 28, 2023

In terms of administrative and regulatory lessons learned, the team reflected that the integration of PT/DC at the forefront of the patient experience is often different from many typical processes. There have also been hiring challenges related to the current job market, as well as regulatory challenges related to consent waivers and IRBs.

Trials 130

Trials Research Medicine Doctors 130

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. New Science is clearly on the rise. However, New Science is more expensive to develop.

Clinical Trials 90

Clinical Trials Clinical Trials Development Marketing 90

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

MARCH 22, 2023

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. Increased competition from generics and biosimilars has also prompted widespread change within the industry.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

Cloudbyz

JUNE 1, 2023

This feature enables you to expand Salesforce’s functionality beyond its standard sales, service, and marketing applications. These features enable organizations to provide a tailored experience for their users and maintain accurate financial records across diverse markets. government data).

Compliance 78

Compliance Development Branding Production 78

Drug Discovery World

NOVEMBER 13, 2023

Andre Mueller, PhD, Marketing Manager, Biologics Solutions, Unchained Labs, said: ‘Tackle high-concentration biologics with the right toolkit’. Fabian Mohr, PhD, Vice President Research & Development, IBA Lifesciences, on: ‘Developing a robust affinity tag platform using engineered streptavidin’.

Protein 59

Protein Antibody Engineer Scientist 59

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. and four additional selling days in international markets. in December 2019; and. in December 2019; and.

Vaccination 40

Vaccination Vaccine Production Sales 40

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. A major breakthrough in the technology was the development of biologically active fluorescent reagents that could be detected by the instruments.

Reagent 52

Reagent Antibody Drugs Protein 52

Pharmaceutical Technology

NOVEMBER 30, 2022

According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. 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. million in Q3. compared to a 5.1%

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. 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. million in Q3. compared to a 5.1%

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246