EMA to consider rolling review for Merck's molnupiravir in coming days (Reuters)
Europe’s drug regulator said a booster shot of the Pfizer-BioNTech vaccine could be given to healthy adults. (NYTimes)
NICE recommends first new sickle cell disease treatment in 20 years (Pharmafile)
Norway to offer COVID vaccine booster to those aged 65 and older (Reuters)
Pharma & Biotech
GlaxoSmithKline abandoning iconic US HQ space in a shift inspired by the new normal (Endpoints)
Innovative Licensing and Access Pathway (ILAP): New partner announcement (MHRA)
Aduhelm In Medicaid: States Must Cover, CMS Official Says (Pink Sheet)
Gang of 7: Boehringer joins group of companies targeted over drug discount program (Endpoints)
Gemini axes CSO and 20% of staff to focus on late-phase plans (Fierce)
Vedanta brings home a win for lead microbiome program, passing a PhII test and clinching BARDA investment (Endpoints)
Ex-FDA officials ask SCOTUS to take up J&J talc case; Annovis shows data from PhII Parkinson's trial (Endpoints)
A month after a manufacturing hiccup led to a CRL, CorMedix CEO will retire (Endpoints)
Medicxi co-founder David Grainger gets his other foot in Centessa's door as chief innovation officer (Endpoints)
New small molecule player with roots in David Liu's lab collects another $78M to fuel search for exosites (Endpoints)
iOmx refuels with $75M+ on its search for immune checkpoint targets on tumor cells (Endpoints)
Medtech
MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference (MedtechDive)
Hologic begins broad European launch of its tabletop Novodiag tester after its $795M acquisition (Fierce)
EU Classification ‘Bible’ Published To Support Risk Class Decision-Making (MedtechInsight)
Government, Regulatory & Legal
J&J Unit Must Face Claims Pelvic Mesh Was Defective (Law360)
Drugmakers In Zantac MDL Try To Trim Claims (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.