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March 17, 2020
by Michael Mezher

Recon: White House, Senate Look to Bundle Coronavirus Bill, Stimulus Package; Novo Halts Hemophilia Studies on Safety Concerns

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump urges US to halt most social activity in virus fight, warns of recession (Reuters) (NYTimes)
  • In Coronavirus Testing Ramp-Up, US Called Private Sector in Late (Bloomberg) (Harvard Gazette)
  • White House eyes combining House bill with new coronavirus stimulus (Politico) (NYTimes)
  • Mnuchin to pitch Senate GOP on third coronavirus package Tuesday (The Hill)
  • San Francisco orders residents to stay home but says it's 'not a time to panic' (Reuters)
  • Merck drug reduces cough frequency but taste alterations could cloud prospects (STAT) (Endpoints) (Press)
  • As the market craters, Keros Therapeutics files for an IPO (STAT)
  • Trump urges states to secure their own medical supplies for coronavirus (The Hill)
  • Mallinckrodt loses a court case and is on the hook for $650 million in overdue Medicaid rebates (STAT)
  • In another win for rival Aimmune, FDA presses pause on DBV's peanut patch with additional questions (Endpoints) (Press)
  • Aimmune sees coronavirus slowing down marketing of peanut allergy therapy (Reuters)
  • Before Trump’s inauguration, a warning: ‘The worst influenza pandemic since 1918’ (Politico)
In Focus: International
  • China gives go-ahead for human trials of potential COVID-19 vaccine: state media (Reuters) (Press)
  • WHO urges Europe to take "boldest" actions against COVID-19 epidemic (Reuters)
  • WHO calls for "change of mindset" to overcome pandemic shortages (Reuters)
  • Sobering coronavirus study prompted Britain to toughen its approach (Reuters)
  • Special Report: 'All is well'. In Italy, triage and lies for virus patients (Reuters)
  • G7 leaders vow to do what it takes to fight coronavirus, support economies (Reuters)
  • Entry into EU's Schengen zone to close - Macron (Reuters 1, 2)
  • EU seeks to prevent US takeovers of coronavirus research firms (Reuters)
  • CureVac says no requests to reserve production for US, scientists were not lured (Reuters)
  • Coronavirus vaccine developer CureVac CEO to go on temporary medical leave (Reuters) (Endpoints) (Press)
  • Global spending on drugs may hit $1.1 trillion by 2024, but the rate of growth is forecast to slow (STAT)
  • Safety issues force Novo Nordisk to shutter PhIII hemophilia trials (Endpoints) (PMLive)
  • AstraZeneca's Imfinzi shows sustained benefit in lung cancer study (Reuters) (Pharmafile) (Endpoints) (Fierce)
  • EU Guides On ATMP Trials, Genetically Modified Cells To Be Finalized This Year (Pink Sheet-$)
Coronavirus Outbreak
  • Coronavirus Is Hiding in Plain Sight (NYTimes) (Science)
  • Do Antibody Testing to Understand Covid-19 (WSJ)
  • Blood-Sample Shortages Slow Search for Coronavirus Drug (WSJ)
  • Hopes of a coronavirus vaccine mount as three key biotech players make progress (CNBC)
  • Regeneron says potential Covid-19 drugs could start human tests by early summer (STAT) (Reuters)
  • Trials of potential coronavirus treatments start for some existing drugs (Reuters)
  • Coronavirus Vaccine: How Hard Might Development Get? Look At Chikungunya (Pink Sheet-$)
  • FDA commissioner: Be wary of anyone claiming they can cure COVID-19. Talk to your doctor. (USA Today)
  • Lower death rate estimates for coronavirus, especially for non-elderly, provide glimmer of hope (STAT)
  • COVID-19 Has Caused A Shortage Of Face Masks. But They're Surprisingly Hard To Make (NPR)
  • A Top Cancer Hospital Faces Mask Shortages As COVID-19 Cases Show Up In Staff And Patients (Buzzfeed)
  • WHO confirms two coronavirus cases among its staff (Reuters)
  • German institute: Two years for pandemic to run its course (Reuters)
  • Italian start-up 3D prints valves to help coronavirus patients (Reuters)
  • Inside the Coronavirus Response: A Case Study in the White House Under Trump (NYTimes)
  • Live tracker: How many coronavirus cases have been reported in each US state? (Politico)
  • New York state coronavirus cases soar to about 1,700, hospitalizing 19% (CNBC)
  • The Drug Channels Coronavirus Industry Impact Survey (Drug Channels)
  • US prescription drug supply chains face coronavirus stress test (The Guardian) (Center for Biosimilars)
  • 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-$)
  • Sacklers Say Major Purdue Deal Hinges On Longer Ch. 11 Stay (Law360-$)
  • Medical Device Summary Judgment Win in Florida (Drug & Device Law)
  • Impact of COVID-19 Pandemic on Patent Offices and Federal Courts (Patent Docs)
  • FDA requires new health warnings for cigarette packages and advertisements (FDA)
Europe
  • Sweden Urges Pharma To Engage In AMR Initiative (Pink Sheet-$)
  • UK’s Devices Bill Can Clarify Big Data’s Health Care Potential, Says Lawyer (MedtechInsight)
  • Blood bank compliance report template (MHRA)
Asia
  • Hong Kong regulator will continue to recognize South Korean approvals (Emergo)
India
  • Accredited private labs to be allowed to test for Covid-19 (Economic Times)
Canada
  • Nucala approved in Canada for use in adolescents with severe eosinophilic asthma (PharmaLetter-$)
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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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