Gilead sees better days ahead for CAR-T therapy Yescarta with Amsterdam manufacturing hub online (Fierce)
Magenta's technology attracts another gene therapy developer (BioPharmaDive)
Takeda spins out a pipeline of ‘interesting but still difficult’ psych drugs in $2B deal as it wraps up a post-merger R&D shakeout (Endpoints)
Adding billions in value, Eli Lilly succeeds where Pfizer failed, halting breast cancer recurrence (Endpoints)
A failure at Eli Lilly, the comeback drug teplizumab shows off more upbeat diabetes data in the run-up to an FDA filing (Endpoints)
Billions on the table, GSK’s Hal Barron antes $120M cash to partner with a specialist in synthetic lethality (Endpoints)
Eyeing a hot IPO market, 4DMT tops up its cash reserves and preps a leap into the clinic with bespoke gene therapy vectors (Endpoints)
Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA (Pink Sheet)
US FDA Sees Slow But Steady Progress In Adoption Of Continuous Manufacturing (Pink Sheet)
MHLW to Propose Two-Third Sampling Rate for Wholesaler Survey for Off-Year Drug Re-Pricing; Go/No-Go Debate to Continue (PharmaJapan)
4 Life Sciences Companies Launch IPOs Totaling $588M (Law360)
Medtech
FDA Doubles Test Review Staff, Is Prioritizing EUA Reviews For Home-Use And High-Batch Tests (MedtechInsight)
Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias (MedtechDive)
Myriad prostate cancer test wins coverage from Aetna (MedtechDive)
Government & Regulatory
It's not just Charles Lieber: NIH's ongoing investigation has swept up 54 scientists who violated rules about foreign ties (Endpoints)
Proposed delayed commencement of certain medical device regulatory changes (TGA)
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.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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