Recon: HHS Hit by Cyberattack; US Senate Scrambles on Coronavirus Bill as Europe Locks Down

• Senate scrambles on coronavirus package as US begins to shut down  (Politico) (The Hill)
• Cyber-Attack Hits US Health Agency Amid Covid-19 Outbreak (Bloomberg) (Reuters)
• US states plea for coordinated national response to coronavirus (Reuters)
• Government official: Coronavirus vaccine trial starts Monday (AP)
• Sanofi, Regeneron begin testing arthritis drug as coronavirus treatment (Reuters) (Press)
• J&J ramps up Tylenol production as demand surges (Reuters)
• Google coronavirus website touted by Trump opens for two CA counties (Reuters) (Verily) (STAT)
• FDA Looks to Help Ramp Up Testing for COVID-19 Across the US (Focus)
• Thermo Fisher to produce millions of coronavirus diagnostic tests (STAT) (Reuters)
• Americans will have access to more than 2,000 labs for coronavirus testing, Pence says (Reuters)
• J&J says no evidence HIV drug works against coronavirus (Reuters)
• Another antibiotic maker bites the dust, as Tetraphase is swallowed for cheap (Endpoints) (Press)
• Opioid Settlement Offer Provokes Clash Between States and Cities (NYTimes)
• DC Circ. Signs Off On Serial Exclusivity For Orphan Drugs (Law360-$)
• Unum gets a reprieve from the FDA — partial hold lifted after 9 days (Endpoints)
• Teva, Celltrion Announce US Launch of Herceptin Biosimilar (Press)
• As coronavirus pandemic worsens, health officials fear nationalization of drugs and supplies (STAT)
• White House advisor Navarro: I’m bringing an executive order to Trump that would reduce US foreign dependency on medicines  (CNBC) (Reuters)
• The shadow coronavirus czar (Politico)

• Germany Accuses US of Trying to Lure a Drug Maker Working on Coronavirus Vaccine (WSJ) (Reuters) (NYTimes) (CNBC) (Reuters) (Endpoints) (The Guardian)
• WHO: Some nations aren’t running enough coronavirus tests: ‘Test every suspected case’ (CNBC)
• World closes borders, restricts travel to contain coronavirus spread (Reuters)
• As Europe Shuts Down, Britain Takes a Different, and Contentious, Approach (NYTimes) (Endpoints)
• Crowded, poor South Asia sees steady rise in coronavirus cases (Reuters)
• UK coronavirus crisis 'to last until spring 2021 and could see 7.9m hospitalised' (The Guardian) (The Hill)
• S. Korea not to use Japan's Avigan as coronavirus drug (Yonhap)
• Sanofi urges Europe to add vaccine manufacturing capacity (Financial Times)
• China biotech InnoCare raises $288 million in Hong Kong IPO: sources (Reuters)
• No evidence ibuprofen bad for COVID-19 patients: Nurofen-maker (Reuters)
• Merck KGaA, Pfizer’s Bavencio stumbles in head and neck cancer (PMLive)
• Merck's Keytruda pulled from England's Cancer Drugs Fund in bladder cancer (Fierce)
• NHS England will make PrEP for HIV available in April (PMLive)
• BioNTech in China alliance with Fosun over potential coronavirus vaccine (Reuters) (Fierce) (Press)
• Healthcare group Novacyt wins British orders for coronavirus testing product (Reuters)
• Sanofi says production running as per normal, sees no shortages (Reuters)

• Coronavirus Vaccine Dreams (NYTimes)
• Here’s What’s in Congress’s Emergency Coronavirus Bill (NYTimes) (Reuters)
• There’s a Giant Hole in Pelosi’s Coronavirus Bill (NYTimes)
• CDC urges: No more gatherings of 50 people (Politico) (NPR)
• Explainer: Here's what Trump's declaration of coronavirus emergency means (Reuters)
• How South Korea Scaled Coronavirus Testing While the U.S. Fell Dangerously Behind (ProPublica)
• This Coronavirus Is Unlike Anything in Our Lifetime, and We Have to Stop Comparing It to the Flu (ProPublica)
• As the coronavirus spreads, a drug that once raised the world’s hopes is given a second shot (STAT)
• Doctors push for treatment of coronavirus with blood from recovered patients (NBC)
• Silicon Valley Ramps Up Efforts to Tackle Virus (WSJ)
• Biogen’s Covid-19 tally breaks past the 100 mark, feeding the state total as the contagion wreaks havoc (Endpoints)
• Did a Biogen exec flee to China in search of emergency Covid-19 testing and care? (Endpoints)
• Spain Imposes Nationwide Lockdown to Fight Coronavirus (NYTimes)
• Spain's coronavirus cases rise to 8,744, death toll up at 297 (Reuters)
• Germany to shutter most shops, bars, churches (Reuters)
• Iran's death toll from coronavirus increases to 853: official (Reuters)
• France struggling to curb rate of coronavirus pandemic, health official says (Reuters)
• Britain set to isolate over-70s as coronavirus deaths rise to 35 (Reuters)
• Canada toughens coronavirus screening for visitors, Trudeau to unveil further measures (Reuters)
• Canada's hardest hit province limits virus testing as demand grows for swabs (Reuters)
• Coronavirus may be slowing in Italy's worst hit region: governor (Reuters)
• Why Even A Huge Medical Stockpile Will Be Of Limited Use Against COVID-19 (NPR)
• Beijing city government says imported coronavirus cases to cover all treatment fees (Reuters)
• Dutch coronavirus infections rises by 278 to 1,413, 24 deaths (Reuters)
• Japan coronavirus infections rise to 1,484: NHK (Reuters)
• Malaysia virus cases jump to 553, most linked to big Islamic gathering (Reuters)
• India proposes regional fund to fight coronavirus as cases exceed 100 (Reuters)
• Make us ventilators to fight coronavirus, UK asks Ford and Rolls Royce (Reuters)
• Bahrain reports first Gulf death from coronavirus (Reuters)
• Singapore reports 17 new cases of coronavirus in biggest daily jump (Reuters)
• Greece says fatalities from coronavirus rose to four (Reuters)
• Turkey reports 12 new coronavirus cases in largest daily rise, brings total to 18 (Reuters)
• Vietnam's coronavirus cases rise to 57: health ministry (Reuters)
• Philippines' coronavirus death toll rises to 12, cases spike to 140 (Reuters)
• Russia builds coronavirus hospital in Moscow as cases rise (Reuters)
• Lebanon, already grappling with economic crisis, now faces coronavirus shutdown (Reuters)
• Kenya raids shop selling fake coronavirus kits as Liberia confirms first case (Reuters)
• These Lab Animals Will Help Fight Coronavirus (NYTimes)
• Doctors, and insurers too, urge patients to get medicine on hand (Reuters)

• Upcoming market catalysts in Q2 2020 (Nature)
• US FDA Outlines Wishlist For Decentralized Clinical Trials (Pink Sheet-$)
• To quell unpredictable allergic reactions, an experimental drug takes aim at a genetic cause, not symptoms (STAT)
• Hand Sanitizer Shortages Push FDA to Let Pharmacists Make It (Bloomberg) (FDA)
• FDA Can’t Do Enough to Ease Medical Shortages, Experts Worry (Bloomberg Law)
• Drug makers grounding salespeople as coronavirus impact on business spreads (STAT)
• Pfizer tells all US salespeople they must work remotely (CNBC)
• Amarin sidelines field sales team for Vascepa amid growing COVID-19 pandemic (Fierce)
• The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics (Pink Sheet-$)
• The BPCIA Transition: Products, Patents And Exclusivities (Pink Sheet-$)
• Redx Pharma set to be bought by US investment group (PharmaLetter-$)
• China’s Global Pharma Supply Chain Operations Resuming In Wake Of Outbreak, USP Says (Pink Sheet-$)
• Allogene chair, former Kite Pharma CEO Belldegrun reveals COVID-19 diagnosis (Fierce)
• FDA greenlights Celltrion HIV drug manufacturing facility in South Korea (Pharmafile)
• Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms (FDA)

• Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the U.S. Food and Drug Administration for Voclosporin in the Treatment of Lupus Nephritis (Press)
• Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA’s Center for Veterinary Medicine and Announces Ashlee E. Watts, DVM, PhD, DACVS as Principal Investigator (Press)

• Qiagen Recalls Software for Rotor-Gene Q PCR Platform (GenomeWeb)
• Natera breaks ties with Qiagen on NGS testing, citing Illumina deal (MedtechDive)
• Value-based payment models take hold in medtech, but barriers slow shift (MedtechDive)
• Hospitals advised to rethink elective procedures, potentially straining device makers (MedtechDive)
• Endologix Receives FDA Approval for Alto Abdominal Stent Graft System (Press)

• Inovio Investors Sue After COVID-19 Vaccine Claims Busted (Law360-$)
• States' Case No Bellwether In Price-Fixing MDL, Teva Says (Law360-$)
• White House eyes additional cash for Pentagon, Homeland Security as virus outbreak widens (Politico)
• The Supreme Court postponed next week’s arguments due to coronavirus precautions (Vox)
• Impact of COVID-19 Pandemic on Patent Offices and Federal Courts (Patent Docs)
• If FDA Won’t Regulate, Maybe the Courts Will: First Circuit Opines on Listing Device Patents in the Orange Book (FDA Law Blog)
• Excellent Warnings Causation Decision out of the Taxotere MDL (Drug & Device Law)
• The High Cost Of Being Trump’s Enemy (KHN)
• Bayer Advances Toward Resolving Roundup Litigation (WSJ)
• NIH Reports First Known Employee with COVID-19 Infection (NIH)

• The MDCG cybersecurity guidance – a helpful rush job (MedicalDevicesLegal)
• Generics group demands ‘immediate and urgent actions’ on EU medicines supply (PharmaLetter-$)
• Industry And EU Bodies Get Together On Covid-19 Threat (Pink Sheet-$)
• Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk (EMA)

• Bulk drug units may not have to assess environment impact (Economic Times)
• Exporters line up for restricted API license (Economic Times)
• No shortage of APIs and formulations in the country: Govt (Economic Times)
• Alembic Pharma receives 4 observations from USFDA for Panelav facility (Economic Times)
• OPPI members reiterate commitment to address coronavirus situation in India (Economic Times)

• TGA cautions against over-buying medicines (TGA)