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Recon: Senate Scrambles After Coronavirus Stimulus Stalls Sunday; FDA Rejects Lilly’s Jardiance for Type 1 Diabetes
Recon: Senate Scrambles After Coronavirus Stimulus Stalls Sunday; FDA Rejects Lilly’s Jardiance for Type 1 Diabetes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Trump Says Coronavirus Cure Cannot ‘Be Worse Than the Problem Itself’ (NYTimes ) (Reuters )
Coronavirus stimulus bill fails to move forward; McConnell cites 'obstruction' (NBC ) (Vox )
Senate scrambles to finish coronavirus package by end of day (Politico ) (The Hill )
Coronavirus forces states to order nearly one in three Americans to stay home (Reuters )
FDA Lifts Import Curbs on Maker of Unproven Virus Drug in India (Bloomberg )
FDA is working on treatment for coronavirus with blood from recovered patients (NBC )
Trump’s Embrace of Unproven Drugs to Treat Coronavirus Defies Science (NYTimes )
States work to limit prescriptions of potential coronavirus drugs (Reuters )
Roche gets FDA nod for trial to test arthritis drug on coronavirus patients (Reuters ) (Press )
Roche CEO says broad coronavirus testing will take weeks: CNBC (Reuters )
Healthcare group Novacyt wins US approval for coronavirus test (Reuters )
Eli Lilly to delay new studies due to coronavirus outbreak (Reuters ) (Endpoints )
No surprise: After near unanimous adcomm, FDA rejects Eli Lilly bid to bring Jardiance to type 1 patients (Endpoints )
Rand Paul becomes first US senator to test positive for coronavirus (Reuters ) (The Hill )
Trump rejects calls to directly use Defense Production Act (The Hill ) (ProPublica )
White House $46 billion emergency request balloons to $242 billion in Senate coronavirus stimulus talks (The Hill )
In Focus: International
Global coronavirus cases cross 350,000, death toll passes 15,000 as pandemic takes hold (CNBC )
UN to create global coronavirus fund, Norway says (Reuters )
Lockdowns not enough to defeat coronavirus: WHO's Ryan (Reuters )
WHO launches global megatrial of the four most promising coronavirus treatments (Science Mag )
U.K. Watchdog Warns Pharmaceutical, Food Industries Against Exploiting Coronavirus (WSJ )
India to Spend $1.3 Billion to Boost Pharmaceutical Production (Bloomberg )
South Korea reports fewest new coronavirus cases since February 29 peak (Reuters )
AbbVie waives all worldwide restrictions on making generic copies of its Kaletra HIV pill (STAT )
Nigeria records chloroquine poisoning after Trump endorses it for coronavirus treatment (CNN )
UK's Smiths makes ventilator available to other producers (Reuters )
Back to China: companies see a safe haven emerging as the virus takes over the rest of the world (BioCentury )
Coronavirus Outbreak
Warmer Weather May Slow, but Not Halt, Coronavirus (NYTimes )
Race to find treatment using re-engineered medicines (Financial Times )
Scientists Identify 69 Drugs to Test Against the Coronavirus (NYTimes )
Lost Sense of Smell May Be Peculiar Clue to Coronavirus Infection (NYTimes )
The Best-Case Outcome for the Coronavirus, and the Worst (NYTimes )
The virus can be stopped, but only with harsh steps, experts say (NYTimes )
New York coronavirus cases surge 38% overnight to 20,875 (CNBC )
NY Will Start Using Trial Drugs on Tuesday to Treat Patients (Bloomberg )
Ohio, Louisiana, Delaware Order Residents To Stay Home As Cases Of COVID-19 Rise (NPR )
COVID-19: EU institutions take action to procure life-saving medical equipment (Europarl )
CDC Coronavirus Testing Decision Likely To Haunt Nation For Months To Come (KHN )
U.S. axed CDC expert job in China months before virus outbreak (Reuters )
Government watchdog launches review into HHS' coronavirus response (CNN )
A Onetime Germ-Warfare Site Is Army’s Front Line in Coronavirus Battle (WSJ )
'A slow burn': Coronavirus symptoms often linger before worsening (NBC )
Former FDA head: 'Life's never going to be perfectly normal until we get to a vaccine' (The Hill )
Britain now has access to 12,000 ventilators: health minister (Reuters )
Cuban doctors head to Italy to battle coronavirus (Reuters )
Germany's infection curve could be flattening off, public health chief says (Reuters )
Germany reports 22,672 coronavirus cases, 86 deaths (Reuters )
Spain's coronavirus death toll adds 462 overnight - health ministry (Reuters )
Spain to treat thousands of coronavirus patients in conference hall as toll tops 1,000 (Reuters )
Canada coronavirus death toll jumps, officials could punish those ignoring precautions (Reuters )
India shuts down flights, big cities as coronavirus toll rises in region (Reuters )
Turkey threatens to seize factories unless they sell masks to government (Reuters )
Honeywell, 3M to ramp up N95 face masks production (MassDevice )
AlloVir, Baylor ally to develop COVID-19 T-cell therapy (Fierce )
Bioneer Receives CE Mark for Coronavirus Kits, Inks Supply Agreement With Romania (Genomeweb )
Fiat Chrysler CEO says group to produce face masks in Asia: union representative (Reuters )
Releasing inmates, screening staff: U.S. jails and prisons rush to limit virus risks (Reuters )
UK scientists to track mutations in coronavirus to map spread (Reuters )
Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients (Press )
No evidence to support intravenous high-dose vitamin C in the management of COVID-19 (TGA )
Pharmaceuticals & Biotechnology
Lupus Patients Can’t Get Crucial Medication After President Trump Pushes Unproven Coronavirus Treatment (ProPublica )
Covid-19 is reshaping the world of bioscience publishing (STAT )
As Covid-19 spreads, disruptions to clinical trial and drug development accelerate (STAT )
ADAPTABLE: The Future of Big Clinical Trial Design? (Medpage )
Heartburn Drugs Tied to Bone Fractures in Children (NYTimes )
Thalidomide Use Did Happen Here, These Americans Say (NYTimes )
The Story of Thalidomide in the U.S., Told Through Documents (NYTimes )
The unseen survivors of thalidomide want to be heard (NYTimes )
Boehringer kicks back unwanted Amylin analog drug work to Zealand Pharma (Fierce )
Startup Spotlight: Carisma Therapeutics wants to make a cell therapy that will work in solid tumors (STAT )
Bayer inks up with “small” Indian biotech for new approach at an old target (Endpoints ) (Economic Times )
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
AbbVie, Roche's Venclexta nails confirmatory combo trial in AML after flopping earlier study (Fierce ) (Press )
Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency (Press )
Medical Devices
RaySearch Labs issues urgent field safety notice for certain RayStations (MassDevice )
Canon Medical Receives FDA Clearance for Compressed SPEEDER Technology for 3T MR System (Press )
US: Assorted & Government
Coronavirus Product Communications Would Get Safe Harbor Under Senate Bill (Pink Sheet -$)
Antibiotics May Finally Get Better Medicare Payments Under US Senate COVID-19 Aid Package (Pink Sheet -$)
Senators Who Led Pro-Pharma Patent Reform Get Drugmaker Cash (KHN )
Chugai sues Fresenius Kabi in the USA for patent infringement (Pharmaletter )
Calif. Pay-For-Delay Ban Hurts Pharma Cos., 9th Circ. Told (Law360 -$)
PTAB Axes Bulk Of Possible Cancer Treatment Patent In PGR (Law360 -$)
Shkreli-Founded Co. Defends Its Handling Of Life-Saving Drug (Law360 -$)
On Promoting Off-Label Use (Drug & Device Law )
Preemption (and Some Other) Lessons from Amiodarone Litigation (Drug & Device Law )
Bayer mediator says glyphosate settlement talks slowed by coronavirus (Reuters )
Europe
The MDCG guidance on significant changes – a significant change? (medicaldeviceslegal )
BIA welcomes UK government’s R&D tax credit cap amendment (Pharmaletter )
Pharma industry rejoices as German court slams down Unified Patent Court system (Pharmaletter )
Regulatory approval for Coronavirus (COVID-19) test kits (MHRA )
Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak (MHRA )
India
India to spend $1.3 billion to boost pharmaceutical production (Economic Times )
DCGI to fast-track approval for Covid-19 drug, vaccine (Economic Times )
Coronavirus: ICMR recommends hydroxychloroquine for high-risk population (Economic Times )
Bengaluru based Skanray starts work on new ventilator design that would speed up production locally (Economic Times )
Other International
In the shadow of Ebola and Covid-19, measles rips through Congo (Reuters )
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.
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