This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
As protection against gonorrhoea is not currently a licensed indication for the 4CMenB vaccine in England, the programme utilises off-label use of the vaccine. Evaluating immunogenicity data and a cost-effective modelling analysis, the panel recommended a targeted vaccination programme 4CMenB in those at the highest risk.
Many leaders now prefer podcasts over webinars or whitepapers for staying informed. While its style is conversational, it dives deep into ROI tracking, compliance in influencer marketing, and payer communications. Pharma podcasts deliver complex industry insights in an accessible and time-efficient format.
Imagine managing a stadium-sized audience where each person expects personalized, relevant communication—and regulators are watching every move. Missteps in off-label promotion or data security can trigger legal and reputational risks. That’s what email marketing looks like in pharma. API integration also matters.
The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin.
Introduction Is Big Pharma a villainous label or a misunderstood brand? This article explores the nuances of how this label affects pharmaceutical marketing and what brands can do to respond strategically. This includes explainer videos, thought leadership pieces, and interactive webinars that humanize the research process.
There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job.
Medication Adherence Requires Personalized Communication Alva emphasized that effective counseling about medications—especially those with intimidating FDA warnings—requires compassionate, patient-centered communication.
Just to share a little bit more about our medication packets: these packets are labeled by date and time, and they come in a monthly pill dispenser box. Lastly, just to touch on health literacy—when you add in our simplified digital communication and educational touch points, you really create space for health literacy as well.
The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.” Give your business an edge with our leading industry insights.
In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Whereas SPF 15 blocks approximately 93% of UV-B rays, SPF 30 and SPF 50 increase coverage slightly (97% and 98%, respectively).
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. MAXSHOT.PL via Shutterstock. Give your business an edge with our leading industry insights.
It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”
With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.” Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. AstraZeneca is also eying up label expansions for Imfinzi in non-muscle invasive bladder cancer (NMIBC), a larger market given that 70% of new bladder cancer diagnoses come from this segment.
Eli Lilly is attempting to join fellow pharma companies with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) – drugs originally approved for treating diabetes – gaining expanded label expansions in cardiovascular indications. Give your business an edge with our leading industry insights.
July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.
“This guides every decision we make, as evidenced by our conservative decision to pause shipments of Elevidys for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure (ALF).”
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
By GlobalData Learn more about Strategic Intelligence While success in these indications is putting value on label expansions in earlier lines of therapies, Kolesnikova noted that there are various disadvantages to CAR T therapies. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
Healthcare professionals (HCPs), too, are inundated with branded communications. A trusted brand is one that delivers value beyond the product label. Patient-Centric Communication Todays healthcare audience expects to be spoken tonot talked at. It must be rooted in authenticity and clarity.
Being aware of pharmaceutical advertising laws, fair balance requirements, and off-label promotion restrictions will prevent costly compliance mistakes. Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness. Organizations like the FDA (U.S.),
While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The materials from this webinar are still available on FDAs website ( here ). Since the new administration took office, however, the webinar page has been taken down from FDAs website.
The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.
The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.
Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. We will release exciting details of our upcoming webinar addressing telemedicine soon. Stay tuned.
Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? Click-Through Rate (CTR) : Are recipients engaging with links?
and management communication strategy. In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. ™ hackathons were established, and the ISPE Factory of the Year (FOYA) award category was created.
Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.
Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE.
If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. Rewind to March of 2020, and pharma companies were facing a communication crisis. The crisis that changed everything.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
RFK Jr has also blocked CDC communications, cancelled vaccine panel meetings at the FDA and CDC without explanation, and initiated investigations into links between vaccines and autism. RFK Jr axed all 17 previous members and replaced them with well-known vaccine sceptics and individuals who lack public health expertise.
LabelingLabeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content