Moderna starts dosing patients in mid-stage coronavirus vaccine study (Reuters)
FDA approves Abbvie's drug to control menstrual bleeding due to fibroids (Reuters) (FDA)
AbbVie pens cancer pact with U.S.-China biotech Jacobio (Fierce) (Press)
In Focus: International
Congo declares new Ebola epidemic, 1,000 km from eastern outbreak (Reuters)
Chinese vaccine could be ready by year-end, government body says (Reuters)
US sends Brazil malaria drug unproven for COVID-19 treatment (AP)
Russia Approves Flu Drug’s Use Against Covid-19 (WSJ) (Reuters)
Russia plans coronavirus vaccine clinical trials in two weeks: report (Reuters)
South Korea's Celltrion aims to start in-human COVID-19 drug trial in July (Reuters)
Taiwan approves Gilead's remdesivir to treat COVID-19 (Reuters)
Oxford Biomedica hires French pharma veteran after signing vaccine deal (Reuters)
Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials (Reuters)
UK hospitals to trial five new drugs in search for coronavirus treatment (The Guardian)
US pharma giant seeks marketing authorisation from India for remdesivir (Economic Times)
Medical Journal Issues Correction on Study of Covid-19 and Antimalarial Drugs (WSJ) (NYTimes)
UK's Post-Brexit Medicine Plans Under Pressure (Pink Sheet)
Record number of countries contribute data revealing disturbing rates of antimicrobial resistance (WHO)
Coronavirus Pandemic
Coronavirus started spreading in the U.S. in January, CDC says (NCB)
FDA approves emergency use of Abiomed heart pump for COVID-19 patients (Reuters)
Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020 (FDA)
FDA greenlights Quest, LetsGetChecked home-based coronavirus tests (Fierce)
Pharma & Biotech
Coronavirus Continues to Disrupt Prescription Drug Supplies (NYTimes)
In a stinging setback, Pfizer’s cancer blockbuster Ibrance flops in key adjuvant setting (Endpoints)
COVID-19 could slow progress in reducing cancer death, NCI head warns (BioPharmaDive)
ASCO: Has AstraZeneca finally found a place for long-plagued I-O candidate tremelimumab? (Fierce)
ASCO: Merck, Eisai pad case for liver cancer nod with Keytruda-Lenvima combo data (Fierce)
New research offers hope for a way through the blood-brain barrier, ‘the final frontier for drug delivery’ (STAT)
Incentives And Risks From OTC Drug Monograph Revamp (Law360)
Iterum's future looks uncertain, after lead antibiotic fails consecutive pivotal studies (Endpoints)
The big money: Poised to make drug R&D history, a China biotech unveils unicorn racing ambitions in a bid to raise $350M-plus on Nasdaq (Endpoints)
IPOs abound in the time of coronavirus, as Forma Therapeutics pencils in $150M Nasdaq debut (Endpoints)
Versant-backed, Bristol Myers-stamped Repare Therapeutics guns for $100M IPO (Endpoints)
Myovant’s relugolix wins a pivotal prostate cancer showdown with an old standard — coming down to the wire on approvals (Endpoints)
Eyes on hemophilia prize, Regeneron adds a $100M wager on joint development campaign with Intellia (Endpoints)
BioMarin holds the line on bleeds with 4-year valrox update on hemophilia A — but what's this about another decline in Factor 8 levels? (Endpoints)
Medtech
Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures (FDA)
Gynesonics lands FDA clearance for fibroid-removal system (MassDevice)
How 3 smaller medtechs are navigating COVID-19 (MedtechDive)
Government & Regulatory
Genentech Must Face Claims It Shorted Providers on Cancer Drug (Bloomberg)
10th Circ. Revives Genentech Cancer Drug Dosage Suit (Law360)
Mylan Gets More Sanofi Insulin Pen Patents Nixed At PTAB (Law360)
PTAB Takes Up 1 Of 2 Gilead Challenges To State Univ. Patent (Law360)
Pharma Suppliers Appeal CMA Action Over UK Market Rig (Law360)
Action taken to halt sales of fingerprick coronavirus (COVID-19) antibody testing kits (MHRA)
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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