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Pink Sheet
US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
Medtech Insight
Based on the results of a study with 234 smokers, the FDA cleared an updated indication for Carrot’s Pivot breath sensor, an over-the-counter carbon monoxide sensor that helps motivate people to stop smoking.
Medtech Insight
EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.
HBW Insight
Supplement OWL advisory board members Guru Ramanathan and Russ Michelson answer HBW Insight questions about the site’s progress and the potential for mandatory registration for dietary supplements sold in the US.
Scrip
The WHO indicates that several claim applications have been made under the COVAX no-fault lump-sum compensation program for COVID-19 vaccines. It remains to be seen how the scheme may apply to countries like India, which is also expected to take a call on indemnity to vaccine makers.
Pharma 360
Join Informa Pharma Intelligence for the “Global Oncology Opportunities” webinar!
Scrip
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
HBW Insight
“We are actively researching how to be the first OTC pharmaceutical firm to have a blister strip that satisfies regulations that is also recyclable,” reveals Perrigo's sustainability chief Steve Ramus in an exclusive interview with HBW Insight. Ramus also talks about the importance of being genuine when approaching ESG strategy.
Scrip
In this week's podcast edition of Five Must-Know Things: vaccine efficacy and the Delta and Delta Plus variants; breakthroughs in CRISPR gene editing and microbiome therapies; and the pandemic’s possible effect on regulatory pathways.
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