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The company is also running an open-label, long-term extension to evaluate safety and tolerability over 52 weeks. UCB noted that fenfluramine was generally well-tolerated in this study, aligning with its established safety profile in previous trials focused on Dravet and Lennox-Gastaut syndromes. This field is required.
Eligible participants may enter an open-label extension phase, receiving GlyphAllo for an additional six weeks. The BUOY-1 study builds on successful phase 1 and phase 2a data and will assess the efficacy, safety and tolerability of GlyphAllo in up to 360 adults over six weeks.
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. Can pharma tariffs “Make America Manufacture Again”?
It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Can pharma tariffs “Make America Manufacture Again”?
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.
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.”
Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Can pharma tariffs “Make America Manufacture Again”? Vabysmo generated $4.3bn in sales in 2024, becoming one of Roche’s top-selling drugs, and had high year-over-year growth than Eylea.
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Subjects who conclude the trial will be qualified for an open-label extension trial. Can pharma tariffs “Make America Manufacture Again”? All subjects will be given zagociguat in one of the 12-week durations and a placebo during the other.
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Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. Can pharma tariffs “Make America Manufacture Again”? The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine.
The agency said that safety information can be adequately conveyed using drug product labelling. 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.
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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.”
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This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. 3PLs can unlock cost savings that their customers might find harder to achieve.
Robert Barrie July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference.
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. Can pharma tariffs “Make America Manufacture Again”? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring.
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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. Can pharma tariffs “Make America Manufacture Again”?
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Her career kicked off at 18, when she landed a role at Check Point after successfully cracking a series of online cybersecurity challenges the company had labelled as nearly unsolvable. Image Siwar El Assad 2 July, 2025 AI in pharma Bookmark this Market Access Balancing efficiency with risks: How biopharma companies can.
With its new filing, J&J seems to have set aside concerns about activity in non-BRCA patients, submitting Akeega for approval with a broad HRR-positive label claim. Competition from other PARP inhibitors in mCSPC could be on the way, though.
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.
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.
Its a shot in the arm for Cambridge, Massachusetts-based Moderna as it faces an evolving regulatory environment for vaccines in the US under new Health and Human Services (HHS) Secretary Robert F Kennedy Jr, a well-known vaccine sceptic.
Most Popular Deep Dive Protein degraders: chasing undruggable targets Cargo agrees to Concentra buyout after trial setback, layoffs Apogee touts positive data for atopic dermatitis drug Medical groups, pregnant doctor sue RFK Jr.
Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,
GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality.
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She ranked 2nd on the “Most Powerful International Women” of Fortune Magazine 2019 edition Education: She holds a master’s degree in classics and modern languages from Oxford University Other Affiliations: Emma was appointed as Independent Director for Microsoft board in Dec’19. LinkedIn Total experience: 16 yrs.
However, Science Magazine and STAT have reported two different patient deaths in the trial, based on not-yet-public adverse event reports and interviews with people familiar with the trial. STAT reported last month that a male patient died in June of a cerebral haemorrhage after taking the drug along with the common anticoagulant Eliquis.
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