A Considerable Setback For Cancer Trials Because Of COVID-19, IQVIA/CRI Survey Finds (Scrip)
Once valued at $4B, an embattled Akorn — nursing a market cap of roughly $37M — files for bankruptcy (Endpoints)
Chiesi Group Receives FDA Approval for Ferriprox® (deferiprone) twice-a-day tablets (Press)
Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice 4-5 June 2020 (FDA)
Kadmon to seek FDA approval of drug targeting graft-versus-host disease following positive study outcome (STAT) (Endpoints)
European regulators accept FibroGen's anemia drug for review; Passage Bio's lead gene therapy gets more love from the FDA (Endpoints)
Bezos, Paul Allen funds, a16z put up $100M to build an Illumina of human proteins (Endpoints)
As CEO bounces back from Covid-19, Apellis says FDA meeting clears path to file for an OK on Soliris rival (Endpoints)
HotSpot announces $65M Series B, as Nimbus pioneers look to keep up in a crowding field (Endpoints)
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval (FDA)
Immunomodulatory drugs: temporary pregnancy prevention guidance during coronavirus (COVID-19) (MHRA)
Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19) (MHRA)
Medtech
Medtronic misses mark in Q4 as sales decline 26% (MassDevice)
Health Canada authorizes Abbott COVID-19 antibody test (MassDevice)
Hospitals push FEMA to form broad supply pact with medtech (MedtechDive)
Labs welcome CMS rate for coronavirus antibody testing (MedtechDive)
Trump administration paying huge premium for mask-cleaning machines. Which don't do the job. (NBC)
Government & Regulatory
Small Biotech Companies Could Get Faster USPTO Review Of COVID-19 Patent Applications (Pink Sheet)
Drug overdose deaths drop in U.S. as other deaths of despair rise, report finds (NBC)
New Info Could Boost Allergan ERISA Suit, 3rd Circ. Told (Law360)
AbbVie Says Recent Antitrust Ruling Irrelevant In Humira Case (Law360)
States Join Bid For Virus Delay In Purdue Pharma Bankruptcy (Law360)
Doctor fined $37,800 for alleged advertising breaches including references to COVID-19 (TGA)
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.