UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.
Swissmedic, Switzerland’s medicines authority, recently completed a full review of Switzerland’s classification system for medicines, deeming 500 OTCs previously available only in pharmacies now suitable for marketing in drugstores, as well. Read more about this sweeping change and how it is affecting hundreds of OTC medicines in Switzerland.
Tap into the state of Takeda’s R&D strategy and how it might change in the wake of their Shire acquisition, due to take place in 2019 to the tune of $62.4b. Find out more about Takeda’s new rare diseases therapeutic areas unit, their partnering efforts to build out the pipeline, near term highlights, progress in penetrating Chinese markets, and more.
The Takeda/Shire merger will catapult the new company to the “top 10” pharma list, but greater size brings greater challenges, including manufacturing glitches and review issues. Explore the challenges each company brought to the merger and the new ones the merged faces today.
OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.
Insurers and a neurologist testifying at a May 16 Senate Finance Committee hearing on the CHRONIC Care Act praised the bill’s telehealth provisions. Committee Chairman Orrin Hatch, R-Utah, says he plans to mark up the bill, which has been under development for two years, this week.
> Engaging Patients and Navigating Laws: What To Consider When Developing Health Apps > Telehealth Reforms Praised At Senate Hearing > Philips’ Survey Highlights Gaps In Perceptions Of Health Care > Game On For Akili’s Cognitive Control Tech
> Behind The Scenes Of Digital Health: Medtech Players And Partners > Philips To Create More Context, Connectedness And Continuity And Shift Sick Care To Health Care > New Data Gives Adherium Fuel To Accelerate Digital Tech Adoption in Drug Sector > Siemens Healthineers To Launch Digital ‘One-Stop-Shop’
> Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym > Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s > Interview: Philips Plugs Into Patient Connectivity
The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.
As pharma companies increasingly include access to unlicensed medicines as part of their commercialization game plans, new challenges – and opportunities – are born. In this informative article, In Vivo examines both the potential pitfalls and probable triumphs of incorporating unlicensed medicines into commercial strategies.
Although their patent protection has expired, big-name blockbusters continue to produce huge revenues for the pharmaceutical companies that produce them. Take a look at how some well-known drugs may no longer be making headlines, but continue to be big earners.
According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.
Scrip speaks with Pascal Touchon, Senior Vice President and Global Head, Cell & Gene Therapy at Novartis AG about the company’s encouraging successes with CAR-T therapies, as evidenced by 18-month data released during the December 2018 meeting of the American Society of Hematology.
Immuno-oncology: spurred by the approval of first-generation checkpoint inhibitors in 2014, this important market has continued to grow exponentially, as deals are made not only around checkpoint inhibitors themselves, but also for related molecules and technologies to be used in synergy with them. Examine the origins of this important and growing area in this essential In Vivo report.
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