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Follow all the highlights from this annual meeting of oncology clinicians, researchers, patient advocates, journalists, and members of the pharmaceutical industry with this report extract. Datamonitor Healthcare’s coverage includes:
• Translational cancer science unveiled at ESMO 2019
• Announcements of potentially practice-changing data
• Important developments from the 5-day event
Payers have become increasingly aware of the potential cost burden of multiple myeloma treatment over the past five years, due to several factors:
Pink Sheet
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
Generics Bulletin
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Medtech Insight
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
Scrip
The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.
Medtech Insight
The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
Citeline Study Feasibility
This informative whitepaper introduces you to best practices in study feasibility, which laid the groundwork for our new predictive analytic that is launching soon, Citeline Study Feasibility. Our industry-leading technology will deliver advanced insight to improve your clinical trial decisions, fast-track enrollment and optimize cycle times – all with less effort.
Topic Clinical Trials
Scrip
Arriving two to three months later than planned, Novavax’s nanoparticle-based vaccine is still a welcome addition to the field, for both rich and poor countries.
Scrip
In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.
HBW Insight
Bayer has launched a dedicated Consumer Health business in India to market products in key OTC categories. The company is also working to bring different stakeholders together through the creation of a new organization dedicated to promoting self-care in the South Asian country.
HBW Insight
New York legislation to restrict sales of weight loss and sports nutrition supplements to minors failed without reaching a vote before the end of the session. But the proposal will continue to be a challenge for industry in New York as well as around the country.
Biomedtracker, Datamonitor Healthcare
The Pharma Intelligence analyst team will be covering the 2021 ASCO virtual meeting from June 4-8, 2021.
Medtech Insight
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.
Generics Bulletin
Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.
Pink Sheet
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
Medtech Insight
Updates to the EU Medical Devices Regulation are just weeks away from becoming a reality for manufacturers and suppliers. Medtech Insight delivers expert insights into the latest developments and what they could mean for your business.
Topic Medtech
Scrip
18 Jun 2021
Medtech Insight
18 Jun 2021
Medtech Insight
17 Jun 2021
Pink Sheet
17 Jun 2021
Pink Sheet
17 Jun 2021
Pink Sheet
17 Jun 2021
Pink Sheet
17 Jun 2021
Generics Bulletin
17 Jun 2021
Scrip
17 Jun 2021
HBW Insight
17 Jun 2021
HBW Insight
17 Jun 2021
Pink Sheet
17 Jun 2021
Medtech Insight
17 Jun 2021
Scrip
17 Jun 2021
Medtech Insight
17 Jun 2021
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