You are here:
Homepage
News & Insights Search
Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel
Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Special Report: How the Trump administration secured a secret supply of execution drugs (Reuters )
Trump will sign three executive orders on lowering drug prices: chief of staff (Reuters )
Gilead says remdesivir data show reduced risk of death (Financial Times ) (Endpoints ) (Reuters ) (Press )
FDA Says to Review Side Effect of GSK's Multiple Myeloma Drug (Reuters ) (BioPharmaDive ) (Endpoints )
Blackstone hits $4.6B fundraising goal, teeing up big bets on late-phase R&D (Fierce ) (Endpoints )
Relay Therapeutics, focused on solid tumors, seeks to raise $250M in IPO (STAT )
Despite the pandemic, prices for many drugs keep rising (STAT )
In Focus: International
German Biotech Sees Its Coronavirus Vaccine Ready for Approval by December (WSJ )
Fujifilm's Avigan inconclusive in COVID-19 patients in Japan trial (Reuters )
UK turns down EU coronavirus vaccine scheme (The Telegraph )
NICE backing for Takeda's Adcetris for rare lymphoma (PharmaTimes )
EU Pharmaceutical Strategy Roadmap Seen As Weak On Innovation (Pink Sheet )
Australia approves Gilead's remdesivir for COVID-19 treatment (Reuters ) (TGA )
Coronavirus Pandemic
The Coronavirus Can Be Airborne Indoors, W.H.O. Says (NYTimes )
Trump’s health officials find ways to contradict his message downplaying virus risks (Politico )
These Scientists Raced to Find a Covid-19 Drug. Then the Virus Found Them. (NYTimes )
Hepatitis C drugs help combat Covid-19 in trials (Financial Times )
Fetal coronavirus infection is possible, small study suggests (NBC )
Siemens COVID-19 antibody test beats rivals in head-to-head study (MedtechDive )
Coronavirus (COVID-19) Update: Daily Roundup July 9, 2020 (FDA )
Pharma & Biotech
FDA new drug approvals in Q2 2020 (Nature )
EU Checks Pharma’s Appetite To Share Market Launch Intentions (Pink Sheet )
GSK's Shingrix supply recovers thanks to drop in vaccinations, uninterrupted production (Fierce )
Top biotech analyst projects a gloomy outlook for Pfizer's JAK portfolio (Endpoints )
Ophthalmic drugs, cancer cell therapies attract $340M+ on two HKEX biotech debuts (Endpoints )
Another four biotechs scratch out the first number and ask for more as IPO boom continues (Endpoints )
Bayer's finerenone hits targets in diabetes/kidney disease trial (PharmaTimes )
Allergan Declines To Confirm Abicipar Pegol Fate (Pink Sheet )
UK’s CMA Issues Fines Over Fludrocortisone (Pink Sheet )
Harbour BioMed nabs meaty C round as cancer, COVID-19 work draws investors (Fierce )
AstraZeneca signs computational drug discovery collaboration; J&J-partnered Fate cleared for the clinic (Endpoints )
Bob Goeltz bolts Unity Biotechnology to become CFO at Arcus Biosciences; John Johnson tapped for his latest CEO gig (Endpoints )
A new venture fund amid a pandemic? In the Nordics? Eir Ventures brings it on with €76M first close (Endpoints )
FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity (Press )
Medtech
EU Industry Wants IVDR Delay, Grace Period For More Products And Phased Implementation (MedtechInsight )
Interim FDA-Mandated Postmarket Study Finds Essure Has Significantly Higher Rates Of Adverse Events (MedtechInsight )
Malaysia's MDA publishes post-market surveillance guidance documents (Emergo )
Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020) (MHRA )
Government & Regulatory
Office of Women's Health Strategic Priorities; Establishment of a Public Docket; Request for Comments (FDA )
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA )
Full Fed. Circ. Won't Consider Standing In Novartis Drug Case (Law360 )
Feds Indict 4 In Alleged $34M Pharma Kickback Scheme (Law360 )
1st Circ. Affirms Pharmacists' Guilt In Meningitis Outbreak (Law360 )
NuVasive Spinal Fusion Patents Largely Survive PTAB Review (Law360 )
A Look At CMS' Proposed Medicaid Drug Rebate Changes (Law360 )
Father and Sons Charged in Miami Federal Court with Selling Toxic Bleach as Fake “Miracle” Cure for Covid-19 and Violating Court Orders (FDA )
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.