GSK Q3 top-line down 8%, Shingrix sales drop 30%, Eliipta sales +21% (Seeking Alpha)
GSK culls top respiratory disease prospect, delivering another blow to IL-33 field (Fierce)
PDUFA VII: US FDA Wants Dedicated RMAT Program Funding (Pink Sheet)
‘Dying waiting’: Advocates urge Vertex to widen global access to cystic fibrosis drugs (STAT)
In a Battered New York Office Market, Life Science Is Flourishing (NYTimes)
FDA Approves Lotion for Nonprescription Use to Treat Head Lice (FDA)
Flagship brings 'intersystems biology' under one roof with Senda Biosciences (Fierce)
Tom Abrams’ Steady Leadership Guided US FDA Through Dramatic Changes In Rx Promotion (Pink Sheet)
Indian drugmaker failed to notify FDA multiple times about issues with its sterile injectables: letter (Fierce)
Bristol Myers' Richard Hargreaves pays $70M to launch a neurodegeneration alliance with a star player in the machine learning world (Endpoints)
Chinese rare disease player inks first deal around narcolepsy drug Wakix after grabbing $80M to build an ecosystem (Endpoints)
Roche's major cancer research exec Rommel jumps ship to Bayer as Moeller exits (Fierce)
Vacaville Unveils California Biomanufacturing Center (GEN)
Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer (Endpoints)
UK Confirms It Will Accept EU Marketing Authorizations For Two Years (Pink Sheet)
EU Framework For Patient Preference Studies Under Review (Pink Sheet)
A dark horse entrant into the spinal muscular atrophy field doubles its value on some PhII data (Endpoints)
Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-190584 for the Treatment of Presbyopia (Press)
The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security – Public Meeting (FDA)
Arena's Amit Munshi spins out his neuro sub into a biotech startup, with $56M for the baptism (Endpoints)
RemeGen readies $514M IPO as HKEX adds jewel to the crown (Endpoints)
Medtech
Experts Call For Unifying Measures For EU Political And Regulatory Oversight (MedtechInsight)
IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do (MedtechInsight)
FDA clears Abiomed's Breethe lung life support system, enabling use in COVID-19 (Fierce)
MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There (MedtechInsight)
FDA Bumps PMA Compliance Date For AED Accessories To February 2022 (MedtechInsight) (FDA)
Singapore HSA will introduce UDI labeling requirements for medical devices (Emergo)
LabCorp sees Q3 revenue rise 33%, but doesn't follow Quest in upping guidance (MedtechDive)
Government, Regulatory & Legal
Department of Justice Files Complaint Against California Company To Stop Distribution of Adulterated Animal Drugs (DoJ)
Suboxone Manufacturer Indivior's Former Chief Executive Officer Sentenced to Jail Time in Connection with Drug Safety Claims (FDA)
Judge Wants New Bellwether List In Cook Vein Filter MDL (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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