Not enough Covid vaccine for all until 2024, says biggest producer (FT)
Trump Loyalists Tried to Influence CDC Virus Reports (NYTimes)
Early research from 23andMe strengthens link between blood types and Covid-19 (STAT)
Gilead CEO: We’re studying new ways to treat coronavirus with remdesivir outside of the hospital (CNBC)
As COVID-19 Vaccine Trials Move At Warp Speed, Recruiting Black Volunteers Takes Time (NPR)
Valneva announces major COVID-19 vaccine partnership with UK government (PMLive)
Coronavirus (COVID-19) Update: Daily Roundup September 11, 2020 (FDA)
Pharma & Biotech
Neurocrine launches Parkinson's therapy as COVID-19 related disruptions ease (Reuters)
Cancer Projects to Diversify Genetic Research Receive New Grants (NYTimes)
PIC/S Interprets Checklist For Auditing Drug GMP Inspectorates (Pink Sheet)
How much is a startup worth? For biotech companies, the answer is rarely public (STAT)
US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal (Reuters)
ICER criticizes cost of 8 targeted immune modulators for UC, recommending some deep discounts (Endpoints)
Gilead’s CAR-T player Kite waves goodbye to research chief Peter Emtage as another top exec hits the exit (Endpoints)
Arie Belldegrun and David Chang godfather the $110M launch of a new cell therapy player. And this one is also thinking big (Endpoints)
Thanks to a $77.5M Series B, Escient moves into the clinic with the first of its sensory receptor candidates (Endpoints)
Escape Bio nabs $73M as race with well-heeled Biogen and Denali heats up (Endpoints)
Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts (IPQ)
FDA grants Dupixent® (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitis (Press)
Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME) (Press)
Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS) (Press)
Medtech
Abbott, Illumina, other medtechs shape guide conveying device risks to patients (MedtechDive)
Fitbit to launch first ECG app in U.S., Europe next month (Fierce)
MHRA’s Lee To Give UK Medtech Industry Greater Diagnostics Focus (MedtechInsight)
Government, Regulatory & Legal
Patent board delivers blow to University of California over its CRISPR invention claims (STAT) (Science)
A Pennsylvania lawmaker wants to tie prescription drug prices to what Canada pays (STAT)
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.
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.