Patient Is Reported Free of HIV, but Scientists Urge Caution (NYTimes)
‘It will consume your life’: 4 families take on rare diseases (NYTimes)
EMA fast-tracks review of AZ/Daiichi Sankyo’s HER2 drug (PMLive)
Biogen boosts gene therapy strategy with Harvard pact focused on inherited eye disease (Fierce)
Jonathan Sackler, joint owner of opioid maker Purdue Pharma, dies aged 65 (The Guardian)
Startup PBM Capital Rx, Walmart partner to shed light on specialty, mail-order drug prices (Fierce)
Proposed changes to lung cancer screening guidance could increase scans among Black patients, women (STAT)
Second PhIII study for Idorsia's sleep drug returns positive results, but also raises new questions (Endpoints)
Scientist Makes A Discovery That May Lead To New Drugs For Rare Brain Diseases (NPR)
India coronavirus: Life-saving Covid-19 drugs sold on Delhi black market (BBC)
Indian pharma compliance standards improving, regulatory risks here to stay: Ind-Ra (Economic Times)
AlloVir tests how much an antiviral biotech can reap in a pandemic stock market (Endpoints)
Boehringer Ingelheim ties the knot with Numab on new antibodies; Cabaletta inks pact with Artisan (Endpoints)
Flagship execs take a lesson from nature to master ‘gene writing,’ launching a star-studded biotech with big ambitions to cure disease (Endpoints)
Takeda’s post-merger deals continue as OTC subsidiary is prepared for sale (Endpoints)
Investors give ailing Unum a lease on life and a whole new suite of experimental cancer drugs (Endpoints)
RA Capital doubles down on Siddhartha Mukherjee's vision for a new cell engineering approach, leading Vor's $110M Series B (Endpoints)
EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer (Press)
Medtech
'If the public knew:' Ripple20 shows medical device software cyber weakness (MedtechDive)
FDA approves Abbott's Bluetooth-connected pacemaker, defibrillator implants (Fierce)
Propeller's digital inhaler tech to be co-prescribed with Novartis' new asthma med (Fierce)
Industry Publishes Key Proposals For Development Of Companion Diagnostic Guidance (MedtechInsight)
Dascena wins FDA beakthrough device designation for AI to predict kidney injury (MassDevice)
Government & Regulatory
Generics' Bid To Limit IP Loss 'Makes No Sense,' Judge Says (Law360)
Pharmacies Can't Slip Opioid Nuisance Claims, Counties Say (Law360)
How Therapeutic Formulations Affect Medical Device Patents (Law360)
Fed. Circ. Clears Amgen's Avastin Biosimilar In Notice Fight (Law360)
Sanofi Urges High Court To Expand Arthrex To All (Law360)
Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020) (Patent Docs)
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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