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March 5, 2020
by Michael Mezher

Recon: Moderna Begins Recruitment for Coronavirus Vaccine Study; Europe Braces for Coronavirus-Related Drug Shortages

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House passes $8.3 billion bill to battle coronavirus; Senate vote due Thursday (Reuters) (NYTimes)
  • McConnell Provides Update on Supplemental Funding to Combat the Coronavirus (McConnell)
  • What’s in the coronavirus funding package? (Politico)
  • Recruitment Begins for First Test of Experimental Coronavirus Vaccine (WSJ)
  • Fragile safety net leaves US economy vulnerable to coronavirus hit (Reuters)
  • Trump falsely claimed that Obama administration slowed down diagnostic testing (CNN)
  • Quest Diagnostics to launch coronavirus test service (Reuters) (Press)
  • Big Pharma is on a stock buyback spree (Axios)
  • NeuroMetrix settles $4m false advertising case with FTC (MassDevice) (FTC)
  • Sanofi, Fighting Back in Insulin Price Debate, Says Its Net Prices Fell 11% (WSJ) (Endpoints)
  • Pfizer, Amgen, Lilly spent most to lobby Congress, study finds (BioPharmaDive)
  • Prosthetic innovation: 'It's like you have a hand again' – study (Reuters)
  • What to expect at health tech’s big HIMSS conference — if it happens (STAT)
In Focus: International
  • Europe could face more drug shortages as coronavirus squeezes supplies (Reuters)
  • China announces wider health system reforms amid coronavirus outbreak (Reuters)
  • Anges to develop coronavirus vaccine with Osaka University (Reuters)
  • Coronavirus Epidemic Draws Scrutiny to Labs Handling Deadly Pathogens (WSJ)
  • Oh, Canada! Vertex battles another country over access to cystic fibrosis treatments (STAT)
  • GSK's Emma Walmsley awarded £8.4M pay package after £2.5M rise, finally catching up with fellow pharma CEOs (Endpoints)
  • Zydus Cadila gets DCGI nod for world's first drug to treat liver disease (Economic Times)
  • New TB drug regimen controls resistant disease in 9 of 10 cases: study (Reuters) (NEJM)
Coronavirus Outbreak
  • Coronavirus and the $2bn race to find a vaccine (Financial Times)
  • The coronavirus test will be covered by Medicaid, Medicare and private insurance, Pence says (CNBC)
  • Scientists were close to a coronavirus vaccine years ago. Then the money dried up. (NBC)
  • EU grants governments fiscal leeway to fight coronavirus impact, eyes more (Reuters)
  • FDA Working With Four Labs To Deploy COVID-19 Diagnostic Tests (IHP-$)
  • Co-Diagnostics says demand for coronavirus test kits surge, shares soar (Reuters)
  • EliTech Gets CE Mark for SARS-CoV-2 Detection Kit (GenomeWeb)
  • Coronavirus task force rolls out guidelines for nursing homes (NBC)
  • Senate Homeland Security Ranking Member Calls on Pence to Launch Central Coronavirus Website (Letter)
  • HHS clarifies US has about 1% of face masks needed for ‘full-blown’ coronavirus pandemic (CNBC)
  • Some VA Stockpiles of Protective Medical Masks Aren’t Usable (Bloomberg)
  • Coronavirus spending: an expense — or an investment? (STAT)
  • California declares emergency over coronavirus as death toll rises in US (Reuters)
  • How blood plasma from recovered patients could help treat the new coronavirus (STAT)
  • Robotic arm designed in China could help save lives on medical frontline (Reuters)
  • From ferrets to mice and marmosets, labs scramble to find right animals for coronavirus studies (STAT)
  • A Chinese Doctor Injected Herself With an Untested Coronavirus Vaccine (Vice)
  • China coronavirus infections spike in central city of Wuhan (Reuters)
  • Italy may raise coronavirus support spending to 5 billion euros, minister says (Reuters)
  • Coronavirus death toll jumps to 107 in Italy, all schools shut (Reuters)
  • Iran reports 107 deaths, 3513 infections from coronavirus: health ministry spokesman (Reuters)
  • South Korea declares new 'special care zone' as coronavirus spreads (Reuters)
  • Coronavirus infections jump to 82 in the Netherlands: RIVM (Reuters)
  • New York confirms two more coronavirus cases, state total at 13 (Reuters)
  • France reports two more coronavirus deaths, taking total to six (Reuters)
  • France says it now has 285 confirmed cases of coronavirus (Reuters)
  • Hungary confirms first two coronavirus cases (Reuters)
  • Ireland confirms four new COVID-19 cases to bring total to six (Reuters)
  • Egypt registers first coronavirus case in an Egyptian national returning from Europe (Reuters)
  • Algeria reports nine new coronavirus cases: health ministry (Reuters)
  • Iraq reports second coronavirus death in Baghdad (Reuters)
  • As India coronavirus cases spike, experts daunted by prospect of South Asia spread (Reuters)
  • India shuts Delhi schools, imposes new travel restrictions over coronavirus (Reuters)
  • Japan plans to order two-week quarantine for all Chinese, South Korean visitors – Yomiuri (Reuters)
  • Thailand reports four new coronavirus cases, total 47 (Reuters)
  • Slovenia confirms first case of coronavirus: health minister (Reuters)
  • Hong Kong quarantines dog for coronavirus, experts caution over pet spread (Reuters)
  • Coronavirus: Cruise Ship In Limbo Off California After Former Passenger Died (NPR)
  • Chinese President Xi's Japan visit delayed due to coronavirus (Reuters)
Pharmaceuticals & Biotechnology
  • Is it time to nationalise the pharmaceutical industry? (BMJ)
  • 'Dramatic times': How did an $8B surge in NIH grants over five years change research on the ground (if at all)? (Endpoints)
  • Changing Drug Market Dynamics: An Interview with Craig Garthwaite (The Incidental Economist)
  • Novartis taps Orionis to pursue 'historically elusive targets' (Fierce)
  • Nobody but Deerfield wants Melinta; Novartis finds a new drug discovery partner (Endpoints)
  • Core (Values) Workout (LifeSciVC)
  • MacroGenics loses CMO Jon Wigginton as commercialization looms (Endpoints)
  • Servier bags expanded rights to Cellectis' CD19 CAR-Ts (Fierce)
  • After a trendsetting role in global biotech venture investing, David Mott parts ways with NEA (Endpoints)
  • PsiOxus lures Lillie from Merck to fill CMO position (Fierce)
  • Insights into how Novo Nordisk's Saxenda cuts food cravings may inspire new obesity drugs (Fierce)
  • How do depressed rats respond to psychedelics? New data offer insight into the human experience (Endpoints)
  • Hikma halts production of pain drug because of 'gelatinous particles' in vials (Fierce)
  • Q&A: Mike Dixon (PMLive)
  • Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Reopening of Comment Period (FDA)
  • Training Program for Regulatory Project Managers; Information Available to Industry (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FDA Accepts Mylan’s Bevacizumab Biosimilar Application (Big Molecule Watch)
  • Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder (Press)
  • Can-Fite Updates on Clinical Milestone for its Phase III Rheumatoid Arthritis Study with Piclidenoson; Drugs Combating Rheumatoid Arthritis are Currently Introduced for the Treatment of the Coronavirus (Press)
  • PsiOxus Therapeutics Announces Clinical Trial with Third Cancer Gene Therapy Treatment and Appointment of New Chief Medical Officer (Press)
Medical Devices
  • Axonics execs bullish on breaking Medtronic market stranglehold (MedtechDive)
  • Former FDA leader joins medical device security startup (Health IT & CIO Report)
  • Exact Sciences closes takeovers of 2 cancer testing businesses (MedtechDive)
  • Boston Scientific settles Canadian pelvic mesh case for $21.5m (MassDevice)
  • Could Altair Medical’s wearable reduce opioid deaths? (MassDevice)
  • Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis (Press)
  • Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable Bone Grafting Solution in Spine Procedures (Press)
  • Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease (Press)
US: Assorted & Government
  • Schneider, Hice, Schakowsky Introduce Bipartisan Bill To Address Medical Device Shortages (Press)
  • Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab (Big Molecule Watch)
  • Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute (Big Molecule Watch)
  • Loeb & Loeb Picks Up DLA Piper FDA Team Head In DC (Law360-$)
  • Vaccine IP Under Microscope With Coronavirus Outbreak (Law360-$)
  • 9th Circ. Says Judge Wrongly Put Warning In FDA Complaint (Law360-$)
  • Gilead Can't Duck Sweeping Competition Suit Over HIV Drugs (Law360-$)
  • Celgene Tells Justices Retroactive IPRs Are Unconstitutional (Law360-$)
  • Always Liability Increases? – Don’t Mess With Texas! (Drug & Device Law)
  • USDA Announces Delay of Enforcement of Requirement for DEA Registration of Hemp Testing Laboratories (FDA Law Blog)
  • Life Sciences Court Report (Patent Docs)
Upcoming Meetings & Events Europe
  • EU Committee Gets Tough On Environmental Pharma Pollution (Pink Sheet-$)
  • UK looks to use Brexit to make device industry more transparent (MedtechDive)
  • Stada Arz now biggest foreign pharma investor in Russia (PharmaLetter-$)
  • ‘Last Chance To Save European Innovation' (Pink Sheet-$)
  • Alnylam Pursues Value Framework To Accelerate Givlaari Access In EU (Scrip-$)
  • Janssen files for EMA approval of ponesimod in multiple sclerosis (PharmaLetter-$)
  • Illegal imports of medicinal products: simplified procedure proves its worth (Swissmedic)
Asia
  • Special Report: Before coronavirus, China bungled swine epidemic with secrecy (Reuters)
India
  • Industry seeks exemption for drugs manufactured for only export purposes from export restrictions (Pharmabiz)
Australia
  • International work-sharing initiative - Baloxavir marboxil (Xofluza) (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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