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Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law. NOTE: It is advisable for labels to be printed. Consequently, a patient-centred label strategy is introduced to promote appropriate medication use and adherence. Suggestions include Use larger font sizes (e.g.
The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Don’t let policy changes catch you off guard.
While its style is conversational, it dives deep into ROI tracking, compliance in influencer marketing, and payer communications. The BioPharma Brief” Hosted by scientists-turned-communicators, this podcast delivers news on late-stage trials, FDA activity, and biotech investments.
The impact of packaging is felt only when it does not do its job and therefore pharmaceutical companies have traditionally invested quite a bit on product packs, also using them as part of their branding strategy. sq mm of material – there is more than 20 per cent reduction of packaging material. per cent CAGR. Shivshankar S.R,
It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Sign up for our daily news round-up!
And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not?
June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.
What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 1-3 Detect-A-Dose Lid Label Covers. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork.
The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. How will RFK Jr’s American dream for vaccines play out? 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.”
Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!
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. How will RFK Jr’s American dream for vaccines play out?
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. How will RFK Jr’s American dream for vaccines play out?
Subjects who conclude the trial will be qualified for an open-label extension trial. By GlobalData Learn more about Strategic Intelligence The study is assessing the safety and efficacy of 15 mg or 30 mg of the therapy against a placebo, administered once daily for 12 weeks to those with genetically and phenotypically defined MELAS.
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Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.
The agency said that safety information can be adequately conveyed using drug product labelling. We may still continue to send you service-related and other non-promotional communications. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities.
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. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
Free Whitepaper Future-proofing parenteral packaging against nitrosamines The discovery of large quantities of nitrosamines in many drugs has led to a high number of product recalls in recent years. Download to learn about the causes of contamination and how to adapt your parenteral packaging – one potential source – to minimise the risk.
Reports Contract Injectable Packaging Trends in the Bio/Pharma Industry Data Insights The gold standard of business intelligence. Reports Contract Injectable Packaging Trends in the Bio/Pharma Industry Data Insights The gold standard of business intelligence. How will RFK Jr’s American dream for vaccines play out?
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EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Sarepta confirmed it will work with the FDA to respond to requests for information while advancing the Elevidys safety labelling supplement process. Sign up for our daily news round-up!
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.” How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
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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.
By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. We may still continue to send you service-related and other non-promotional communications. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
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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.
Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? This comes just days after Sarepta said it has agreed to change the black box on the Elevidys label to include ALF and acute liver injury (ALI) warnings.
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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. How will RFK Jr’s American dream for vaccines play out? Don’t let policy changes catch you off guard.
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.
AYUSH Committee, PHD Chamber of Commerce and Industry organised a Conference on Labelling and Packaging Provisions for ASU products recently at PHD House, New Delhi. He also highlighted that a draft notification will soon be coming for the Industry on the indication of packaging.
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For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.
Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.
Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.
MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.
The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting. Pharma communicators take note.
Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.
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