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Articles by Chris Learn
Cell and Gene Therapy CRO Services
Advance your trials confidently through regulatory milestones with a global cell and gene therapy CRO Cell and gene therapy offer patients incredible opportunities. They also come with new regulatory and manufacturing challenges, operational complexity, and market access obstacles. We’ll help you navigate these challenges across North America, Europe, APAC, and beyond as your cell and gene therapies CRO.
Targeting Inflammation in Atherosclerosis: Mechanistic Rationale, Clinical Trials, and Regulatory Considerations
[1]Nedkoff L, Briffa T, Zemedikun D, Herrington S, Wright FL. Global Trends in Atherosclerotic Cardiovascular Disease. Clinical Therapeutics. 2023; 45: 1087–1091. https://doi.org/10.1016/j.clinthera.2023.09.020 [2]Chong B, Jayabaskaran J, Jauhari SM, Chan SP, Goh R, Kueh MTW, et al. Global burden of cardiovascular diseases: projections from 2025 to 2050. European Journal of Preventive Cardiology. 2025; 32: 1001–1015.
Parexel Showcases Industry-Leading Hematology Expertise with Presentation of 10 Research Posters at the American Society of Hematology (ASH) Annual Meeting
Scientific and medical presence at ASH underscores Parexel’s proven expertise at premier event for classical and malignant hematology RALEIGH, N.C., Dec.
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
Get the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO, to help you develop life-changing treatments for patients. Learn more Clinical Trialblazers Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life. Listen Now
Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements
Participate Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions. Learn more Oncology For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care. View story It took 10 years of treatments for Anisha's IBD to enter remission.
AZ says dropping MedImmune will help ‘streamline’ its R&D
The demise of the MedImmune brand, which has driven AstraZeneca’s biologics pipeline for more than a decade, will strengthen the group’s R&D and make it more agile, say executives.
FCB Health’s Neon attracts new managing director
Neon has named Omnicom’s former president Mardene Miller (pictured above) as its new co-managing director. Neon, which is located in New York, US, is a full-service agency specialising in multichannel marketing, strategic planning and health literacy. It has a workforce of around 175 employees and operates under the FCB Health Network umbrella. Miller will lead the 175-workforce agency alongside Kevin McHale, who is also the creative chief.
Merck puts prostate cancer firmly in Keytruda’s sights
Merck & Co/MSD has pressed the accelerator on plans to set up Keytruda as the go-to cancer immunotherapy for prostate cancer, building on its already dominant position in lung cancer.
Biosimilar Herceptin helps Roche gain new Perjeta recommendation
NICE has a history of rowing with Roche over its breast cancer drugs, but peace has broken out in recent times - and now recommendation of a new use for Perjeta will make the NHS an early adopter. The breakthrough is thanks to a Roche discount on Perjeta – but most especially because of the arrival of cheaper Herceptin biosimilars, which have brought down the cost of combination treatment considerably.
Lucid Group acquires digital and creative agency Bluedog
Celebrations are in full swing for Lucid Group today after it announced it has bought London-based digital and creative agency Bluedog. Bluedog brings a “key piece of the jigsaw” to Lucid, commented Lucid’s CEO Dennis O’Brien, referring to the company’s skills in digital design, motion graphics, video development and web design.
Novartis’ Egatan gains US approval for neglected tropical disease
The FDA has given its seal of approval to Novartis’ Egatan, which becomes the first approved treatment in the US for tropical disease fascioliasis. Most commonly known as liver fluke infestation, the disease is caused by two species of parasitical flatworms found in contaminated water or food, and is estimated to affect 2.4m people in some of the world's poorest regions.
Cancer drugs, and China, sustain AZ’s return to growth
AstraZeneca continued its promised return to growth in the fourth quarter as its recovery from patent losses continues, with cancer drugs leading the charge once again. Sales rose 5% to $5.77bn in the fourth quarter, following an upward trend that started in the third quarter and put AZ in positive territory for the full-year for the first time in almost a decade, with a 4% gain to $21.05bn.
Teva will have to endure revenue 'trough' in 2019
Any hope that Teva would swiftly rebound under new CEO Kåre Schultz has been dashed, with the Israeli drugmaker predicting another steep sales decline in 2019. The double whammy of a weak market for its generic drugs and declining sales of former cash cow Copaxone (glatiramer acetate) for multiple sclerosis caused sales to plunge 16% in the fourth quarter to $4.6bn, although Schultz’s cost-cutting drive helped trim the company’s net loss in the period to $2.9bn from $11.6bn a year earlier.
Novartis first to benefit from NICE advice on ‘patient preference’
NICE’s Scientific Advice team has produced its first guidance on how pharma companies can improve clinical trial design to meet the needs of patients and generate evidence for health technology assessment (HTA). The Scientific Advice team is a consultancy offshoot from the cost effectiveness watchdog, providing a fee-based service to biopharma, medical devices and diagnostics companies.
Communiqué Awards 2019 accepting entries
The 2019 Communiqué Awards is now open for entries, calling on healthcare communicators to showcase and share their work with fellow colleagues and stakeholders. The programme, which is now in its 22nd year, is specifically designed to recognise best practice in European, international and local healthcare communications.
Immunotherapy combination trials Q&A
By Chris Learn and Martin Lachs The immuno-oncology (IO) field is becoming incredibly crowded and competitive. What factors should sponsors weigh up when planning a new IO trial in 2019 and beyond?
Mold Rebranding and Refurbishment
The plastics landscape is in a constant state of flux, as new companies pop up, some fall by the wayside, and others consume small and mid-sized facilities and product lines. This can create challenges when product lines, materials and molds change hands: namely, in rebranding. Rebranding might include changing a product name, part number or any identifying mold features when the new owner wants a logo or tool change, or when a product line is moved to a new facility.
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