Recon: Roche, Arrakis partner for RNA drugs; FDA delays decision on Roche SMA drug by three months

• Intelligence report warned of coronavirus crisis as early as November: Sources (ABC)
• Trump says he didn’t know of, still hasn’t seen Navarro memos on possible pandemic (Politico)
• Trump Broke the Agencies That Were Supposed To Stop the Covid-19 Epidemic (Politico)
• Former FDA leaders decry emergency authorization of malaria drugs for coronavirus (Science Mag)
• CDC removes unusual guidance to doctors about drug favored by Trump (Reuters)
• 'No miraculous recovery': Some ICU doctors say hydroxychloroquine isn't helping sickest patients (NBC)
• Kushner’s team seeks national coronavirus surveillance system (Politico 1, 2)
• US coronavirus death projection lowered but official warns of 'second wave' (Reuters)
• Investors await data on coronavirus drugs as market rally builds (Reuters)
• Sage to lay off half of workforce in cost-cutting retrenchment (BioPharmaDive) (Endpoints)
• DEA moves to fight shortages of medicines needed for Covid-19 patients (STAT) (Reuters)
• FDA delays decision on Roche SMA drug risdiplam to Aug. 24 (Reuters) (Endpoints) (Press)
• GM to supply 30,000 ventilators in $500M US contract (Reuters) (HHS)
• Novavax to start human trial for novel coronavirus vaccine (Reuters)
• Roche partners with Arrakis Therapeutics to develop drugs that target RNA (STAT) (Endpoints) (Press)
• Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes (DOJ)

• Trump pledges to put a hold on US funding for WHO (STAT) (NPR) (NYTimes)
• WHO rejects 'China-centric' charge after Trump criticism (Reuters)
• Canada to press US further on medical supplies, Trudeau says (Reuters)
• Head of EU's top science body quits over coronavirus response (Reuters)
• Wealthy nations urged to embrace WTO deal and import meds made under compulsory licenses (STAT)
• China's Wuhan ends its coronavirus lockdown but elsewhere one begins (Reuters)
• Britain trying to get money back for unreliable antibody tests, official says (Reuters)
• UK coronavirus testing capacity boosted by new AstraZeneca, GSK lab (Reuters 1, 2)
• Britain says aiming to roll-out millions of coronavirus tests in months (Reuters)
• Bayer Says Eylea Pre-Filled Syringe Received Approval From European Medicines Agency (Reuters)

• Borders Didn't Stop The Pandemic. But They Might Block The Trade Of Medical Goods (NPR)
• CDC weighs loosening guidelines for some exposed to virus (NBC)
• Special Report: How federal snafus slowed testing at a top US hospital (Reuters)
• US needs more testing to ‘move the economy forward,’ says Johns Hopkins infectious disease expert (CNBC)
• Unprecedented nationwide blood studies seek to track US coronavirus spread (Science Mag)
• Trials of drugs to prevent coronavirus infection begin in health care workers (Science Mag)
• Vietnam to ship 450,000 protective suits to United States (Reuters)
• Opinion: Pharmaceutical Profits and Public Health Are Not Incompatible (NYTimes)
• Vaccine Experts Inject Realism Into US Gov't's COVID-19 Timeline (Pink Sheet-$)
• Mayo Clinic CEO says convalescent plasma could be effective treatment for coronavirus (CNBC)
• US official urges China to allow direct work with Wuhan labs on coronavirus (Reuters)
• With ventilators running out, doctors say the machines are overused for Covid-19 (STAT)
• Private labs do 85 percent of US COVID-19 tests but still struggle with backlogs, shortages (NBC)
• Zydus Cadila boosts HCQ production 10X (Economic Times)
• North Korea testing, quarantining for COVID-19, still says no cases: WHO representative (Reuters)
• Amazon testing disinfectant fog at New York warehouse after coronavirus protests (Reuters)
• German, Swiss companies combine to make disinfectant to kill virus (Reuters)
• India considers narrowing lockdown to coronavirus hotspots (Reuters)
• UK-wide coronavirus death toll increases by 786 to 6,159 (Reuters)
• Iran's new coronavirus death toll passes 3,993: health official (Reuters)
• France is fourth country to pass 10,000 coronavirus deaths (Reuters)
• New coronavirus cases in Italy fall to 25-day low, deaths rise by 604 (Reuters)
• Obesity is major COVID-19 risk factor, says French chief epidemiologist (Reuters)
• Swiss coronavirus death toll goes past 700, positive tests near 23,000 (Reuters)
• Spain's number of coronavirus deaths rises by 757 to over 14,500 (Reuters)
• Dutch coronavirus cases rise by 969 to 20,549, 147 new deaths (Reuters)
• After Deaths At Home Spike In NYC, Officials Plan To Count Many As COVID-19 (NPR)
• Coronavirus (COVID-19) Update: Daily Roundup April 7, 2020 (FDA)
• Alexion plans phase 2 study of Soliris in COVID-19 in coming days: report (Fierce)
• AstraZeneca targets summer start for COVID-19 antibody trial (Fierce)
• Roche takes $25M in BARDA backing to accelerate Actemra trial in COVID-19 (Fierce)
• OraSure wins BARDA contract for in-home coronavirus self-test (MedtechDive)
• HHS, CVS, Walgreens get behind Abbott's coronavirus test (MedtechDive)
• FDA Issues Emergency Use Authorization for Viracor Eurofins Coronavirus LDT (GenomeWeb)
• FDA Issues Emergency Use Authorization for Gnomegen Coronavirus Test (GenomeWeb)
• Genetron Health Gets CE Mark for Coronavirus PCR Test (GenomeWeb)

• Science & Tech Spotlight: CRISPR Gene Editing (GAO)
• Booming VC-Backed Biopharma: Strong Market Despite Pandemic (LifeSciVC)
• COVID-19 brings drug development to a halt (Nature)
• Coordinating the COVID-19 pipeline (Nature)
• Biotech in the time of coronavirus: Pondering the future of ‘JPM Week’ (STAT)
• COVID-19 Economic Fallout May Delay Cell And Gene Therapy Reimbursement Solutions (Pink Sheet-$)
• Accelerating progress in cancer care: Perspectives from six oncology leaders (McKinsey)
• Myriad Genetics pulls sales forecast as coronavirus disrupts operations (BioPharmaDive)
• To avoid DTC dips and communication snafus, pharma marketing shifts amid COVID-19 crisis (Fierce)
• Keytruda nabs another priority review; Quell ties up CAR pact with Hannover Medical School (Endpoints)
• Zai Lab finds latest target in Regeneron’s bispecific, paying up to $190M for Chinese rights (Endpoints)
• ‘If grippe condemns, the secondary infections execute’: What the coronavirus pandemic means for the field of antibiotics (Endpoints)
• Weathering the storm: Another biotech braves Covid-19 in upsized IPO (Endpoints)
• Keros upsizes IPO, raising $96M for blood and musculoskeletal trials (Fierce)

• Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status (Endpoints) (Press)
• BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings (Fierce) (Press)
• NeuClone Announces Completion of Subject Visits in Stelara® (ustekinumab) Biosimilar Phase I Clinical Trial (Press)
• AIVITA Biomedical Provides Update of Ongoing Phase 2 Glioblastoma Trial from Year-End Survival Analysis (Press)

• Study questions TAVR access disparities under new CMS coverage policy (MedtechDive)

• OTC Monograph Reform Becomes Law; HP&M Issues Summary and Analysis (FDA Law Blog)
• Pandemic Delays Federal Probe Into Medicare Advantage Health Plans (KHN)
• Sun Pharma Must Face Celgene’s Suit Over Generic Revlimid (Law360-$)
• Drug Buyers Cut New, Smaller Antitrust Deal With Celgene (Law360-$)
• Prosthetics Cos. To Divest Business To Allay FTC Concerns (Law360-$)
• Pandemic May Spur Reform Of Lab Test Regulation (Law360)
• Delaware Court Dismisses Diabetes Drug Case (Drug & Device Law)

• IQ Productions: Drugs & Biologics – The Regulatory Landscape for Generic Drug and Biosimilar Promotion – 22 April 2020

• MDR amendment proposal article 120 (3) oversight set to be fixed by Council (MedicalDevicesLegal)
• Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012) (MHRA)
• Patients informed to exchange Emerade 300 micrograms adrenaline pens for replacement pens of a different brand (MHRA)
• The GDPR, secondary research purposes and global data sharing—one-wheel too many (European Journal of Human Genetics)

• 0 to 12,000/day: How India scaled up PPE production (Economic Times)
• India’s CDSCO responds to COVID-19 with new approval, import, and safety measures (Emergo)

• Canada Allows Exceptional Drug, Device Imports To Tackle COVID-19 Shortages (Pink Sheet-$)

• Exporting therapeutic goods (TGA)
• Submissions received: Whether the TGA should publish that a prescription medicine is under evaluation (TGA)
• Recall notifications to the TGA or to GS1 Australia's Recall Health platform (TGA)
• Exemption to enable the domestic manufacture and supply of ventilators (TGA)
• Manufacturing medical devices for COVID-19 including 3-D printing (TGA)