In strictest US coronavirus response so far, six Bay Area counties order ‘shelter in place’ (STAT)
A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data (STAT)
UK takes tougher stance to combat coronavirus, as previous approach risks hundreds of thousands of lives — study (Endpoints)
Spain's coronavirus cases surpass 10,000, death toll rises to 491 (Reuters)
More African countries confirm first coronavirus cases as Jack Ma pledges aid (Reuters)
India Scrambles to Escape a Coronavirus Crisis. So Far, It’s Working. (NYTimes)
Dutch coronavirus infections rises by 278 to 1,413, 24 deaths (Reuters)
Austria sees coronavirus cases top 1,000, frees up funds for loan guarantees (Reuters)
Irish PM expects 15,000 coronavirus cases by end of March (Reuters)
France reports 21 more coronavirus deaths, raising total to 148 (Reuters)
Philippines reports 45 new coronavirus infections (Reuters)
Thailand reports 30 new coronavirus cases, total of 177, official says (Reuters)
Indonesia confirms 38 more coronavirus cases, total rises to 172 (Reuters)
Brazil Congress to seek consensus on coronavirus measures (Reuters)
Cambodia reports 12 new cases of coronavirus, bringing total to 24 (Reuters)
Coronavirus-hit British cruise ship finds refuge in Cuba (Reuters)
Man in Broward County assisted living facility dies after novel coronavirus infection (Miami Herald)
U.N. confirms 10 coronavirus cases among German refugees (Reuters)
Portugal confirms first coronavirus death, says more to come (Reuters)
COVID-19 Study Of Gilead’s Remdesivir Using Ebola-Style Adaptive Platform Trial (Pink Sheet-$)
Biogen joins COVID-19 efforts with $10m support fund (PMLive)
After Discovering a Sailor With Coronavirus, the US Navy Crowded Dozens Into One Room (ProPublica)
Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China (JAMA)
Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19 (Nature)
Pharmaceuticals & Biotechnology
Shortcomings in the US Pharmaceutical Supply Chain (JAMA)
Supply disruption scares and price hikes wakeup call for India to reduce dependence on China for APIs, says GlobalData (GlobalData)
The top 10 drugs losing US exclusivity in 2020 (Fierce)
Impact of COVID-19 on Regulatory Enforcement and Approvals (Eye on FDA)
Biotech in the time of the coronavirus: A semi-regular column on the outbreak’s impact on drug makers (STAT)
Children With Pneumonia Don’t Routinely Need Antibiotics (NYTimes)
Generic ‘identity’ gets lost when companies juggle both generic and brand drugs (STAT)
Interview with Dr. Mariana Socal on draft guidance from the FDA aimed at promoting competition in the insulin market. (FDA)
‘It’s like the tortoise and the hare’: A pandemic puts Sanofi’s $600M bet to the test (Endpoints)
Flagship’s Sigilon grabs $80M to bring Robert Langer cell therapy tech into the clinic (Endpoints)
Newly discovered ‘magic methyl’ reaction could turbocharge the potency of some drugs (Science)
Japan’s AGC Makes Agreed €240m Bid For MolMed (Pink Sheet-$)
Acyclovir Availability In US May Be Affected By India Export Restrictions (Pink Sheet-$)
Rick Klausner's Lyell partners, helps fund Eureka's work on cell therapies; Blueprint bounces higher on PhII (Endpoints)
Temporal association between zolpidem medication and the risk of suicide: A 12-year population-based, retrospective cohort study (Nature)
October - December 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
Blue Earth Diagnostics Announces Dosing of First Patient in Phase 3 LIGHTHOUSE Clinical Trial of Targeted PET Imaging Agent rhPSMA-7.3 (18F) in Newly Diagnosed Prostate Cancer (Press)
Lattice Biologics Ltd. Announces Initial Recruitment of Patients for a Phase 1 Clinical Trial to Access Safety and Efficacy of AmnioBoost for Treatment of COVID-19 (Press)
Medical Devices
Endologix secures FDA approval for new abdominal stent graft (MedtechDive)
Intuitive Surgical among 1st big medtechs to predict costly pandemic disruptions (MedtechDive)
Disease management firms set to capitalize on Trump admin interoperability push (MedtechDive)
Becton Dickinson Seeks Emergency US Approval To Ramp Up Coronavirus Tests (Forbes)
Ken Block Consulting Client Receives FDA Breakthrough Device Designation (Press)
US: Assorted & Government
FDA Report Brings Hope For CBD Dietary Supplements (Law360-$)
Conn. Judge Again Finds Pradaxa Claims Preempted (Law360-$)
Cochlear loses appeal over $268m in patent damages (MassDevice) (Law360-$)
Tribunal Awaits Judge's Nod On Daiichi Drug Patent Fight (Law360-$)
Pharmacy Groups Say Scant Facts Doom Pricing Site's Suit (Law360-$)
Drug Wholesalers Look To Derail W.Va. Bellwether Opioid Trial (Law360-$)
Sacklers Say Major Purdue Deal Hinges On Longer Ch. 11 Stay (Law360-$)
Hong Kong regulator will continue to recognize South Korean approvals (Emergo)
India
Accredited private labs to be allowed to test for Covid-19 (Economic Times)
Canada
Nucala approved in Canada for use in adolescents with severe eosinophilic asthma (PharmaLetter-$)
Australia
Update on proposed clarification that certain sports supplements are therapeutic goods (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.
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