Successful Elocta bid should widen access to the drug in the UK (PharmaTimes)
Alnylam's RNAi therapy Givlaari shows lasting effect one year into treatment, new data show (Fierce)
Takeda maps out a discovery alliance aimed at breaking through the safety and efficacy boundaries that limit the first-gen gene therapies (Endpoints) (Fierce)
Elias Zerhouni discusses ‘amateur hour’ in DC, the destruction of infectious disease R&D and how we need to prep for the next time (Endpoints)
Freeline nabs $120M, eyes IPO as its gene therapy comes into focus (Endpoints)
Genmab, Seattle Genetics eye FDA filing for new cancer med after latest data drop (Fierce)
Seattle Genetics, Genmab turn on TV for a highlight reel in cervical cancer — but a rival biotech promises a better show (Endpoints)
Gilead-partnered Goldfinch Bio lands $100M as it pivots to clinical stage biotech (Endpoints)
Zynerba flunks another PhII trial, all but ending Fragile X hopes (Endpoints)
Menten AI Adds Quantum Computing to Develop New Drugs (WSJ)
Rubius marks milestone in PhI/II as CFO departs; Owkin closes $70M Series A; The Carlyle Group bets on Indian CDMO (Endpoints)
WHO urges countries to expand access to rapid molecular tests for the detection of TB and drug-resistant TBc (WHO)
Medtech
Q&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19 (MedtechDive)
What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request? (MedtechInsight)
Brainlab picks up Level Ex, maker of video games for surgeons (Fierce)
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic (MedtechDive)
Masimo announces device designed to reduce opioid withdrawal symptoms (MobiHealthNews)
Medtronic delivers real-world renal denervation data showing better blood pressure after 3 years (Fierce)
Government & Regulatory
How would a Biden White House handle drug prices? Depends on congressional races, analysts say (Fierce)
New BPCIA Complaint: Genentech Seeks to Block Samsung Bioepis’s Proposed AVASTIN Biosimilar (Big Molecule Watch)
AmerisourceBergen CEO Must Testify In Opioid Bellwether (Law360)
Justices Told PTAB Appointments Are Not Unconstitutional (Law360)
Bayer, GE Must Face Suit Over Woman's Chemical Sickness (Law360)
Fortress Drops Ex-Theranos IP Suit To Let Test Co. Fight Virus (Law360)
FDA Ducks Suit Challenging Stimulant Crackdown (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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