Recon: Trump Names Pence to Head Coronavirus Response; FDA Panel Narrowly Backs Lilly’s Cyramza Combo in NSCLC

• US isn’t ready to detect stealth coronavirus spread (Politico)
• CDC Appears To Have Fixed Issue Delaying Coronavirus Testing In US (NPR)
• Pence Will Control All Coronavirus Messaging From Health Officials (NYTimes) (Reuters) (Politico)
• CDC flags possibility of community spread of coronavirus (Reuters) (NYTimes) (CDC)
• Coronavirus Patient in California Was Not Tested for Days (NYTimes)
• Gilead starts 2 late-stage studies for coronavirus drug (Reuters) (Endpoints) (NYTimes) (Press)
• Coronavirus vaccines are far off, FDA official says, drugs could come sooner (STAT) (Reuters)
• Lilly's Cyramza wins narrow thumbs-up from FDA advisers for Tarceva combo in lung cancer (Fierce) (Press)
• FDA pushes back decision on Zogenix epilepsy drug (BioPharmaDive) (Endpoints) (Press)
• Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod (Xconomy) (Fierce) (Press)
• Acacia Pharma's twice spurned drug finally makes the FDA cut (Endpoints) (Evaluate)
• Azar Says HHS Is Open To Medicare Drug Price Negotiation (IHP-$)
• Azar Open To Allowing Imports Of Insulin, Despite Being A Biologic (IHP-$)

• World scrambles to curb fast-spreading coronavirus (Reuters)
• Coronavirus outbreak at 'decisive point': WHO chief (Reuters)
• China reports rise in new coronavirus cases, warns of risk of rebound (Reuters)
• For medicine regulators, reliance is a global imperative (STAT)
• UK follicular lymphoma patients set to get non-chemotherapy therapy as NICE backs Revlimid combo (Endpoints)
• WHO launches a digital version of its Model list of Essential Medicines (EML) (WHO)
• Drug Pricing ‘Not Appropriate Topic’ For WTO TRIPS Council (Pink Sheet-$)

• Researchers Step Up Efforts To Develop A 'Universal' Flu Vaccine (NPR)
• Patient group pushes Trump-backed drug pricing bill (BioPharmaDive)
• Pfizer, Mylan vets tapped for Viatris board, C-suite as merger nears (Fierce)
• Cell therapies can bring insult to injury (Science)
• Pharmacquired: Where are all the deals? (BioPharmaDive)
• FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease (Springer)
• Study finds industry ‘paying price’ for ill-prepared negotiators (PharmaTimes)
• ‘A completely new culture of doing research.’ Coronavirus outbreak changes how scientists communicate (Science Mag)
• Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works (Pink Sheet-$)
• Fujifilm Diosynth Biotechnologies expansion to add cell and microbial capacity (Fierce)
• Spark loses another top exec in the wake of $4.3B takeover by Roche — report (Endpoints)
• 'The headlines are the headlines, but': BioMarin talks up potential savings as hemophilia gene therapy launch looms (Endpoints)
• They have ‘Alzheimer’s brains’ but no symptoms. A new wave of drug developers wants to know why (STAT)
• Health care conference about conflicts of interest has a conflict itself, say critics who won’t attend (STAT)

• Trial of Amgen, Servier’s heart failure drug clears interim check (PMLive)
• Menlo slumps as itching drug fails mid-stage trial (PMLive)
• Sage rethinks SAGE-217 program after phase 3 failure (Fierce)
• FDA approves neratinib for metastatic HER2-positive breast cancer (FDA)
• European Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer (Press)
• Anokion Announces Initiation of Patient Dosing in Phase 1 Clinical Trial of KAN-101 in Celiac Disease (Press)
• PolyPid Announces the Initiation of a Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Sternal Wound Infection Post-cardiac Surgery (Press)
• Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology (Press)
• Inflazome’s Somalix Demonstrates Positive Safety, Tolerability and Pharmacodynamic Profile in its Phase I Study (Press)
• New Player In The Fight Against Resistant Fungal Infections In Phase 3 Trial (Forbes)
• FDA taps chemoradio-sensitizing head and neck cancer drug as 'breakthrough' (Endpoints)
• Tessa gets RMAT designation for new CAR-T; FDA adcomm narrowly votes to expand Eli Lilly NSCLC label (Endpoints)
• Harbour BioMed Receives U.S. FDA IND Approval for Phase 2 Clinical Trial and Orphan Drug Designation for Anti-PD-L1 Monoclonal Antibody, HBM9167 (Press)

• NIH announces $1 million prize competition to target global disease diagnostics (NIH)
• LivaNova loops Verily into depression device study (MedtechDive)
• Wright Medical misses Q4 targets as Cartiva shortfall persists (MedtechDive)
• Psychiatrists plan transcranial magnetic stimulation buys: Wall Street report (MedtechDive)
• Pavmed gains FDA breakthrough nod for esophageal pre-cancer test (MassDevice)
• NuVasive prices $450m offering (MassDevice)
• FDA Once Again Changes Course on LDTs; Eases Up on Pharmacogenomic Test Restrictions (FDA Law Blog)

• Senators threaten to subpoena Express Scripts for failing to produce insulin documents (STAT)
• Fed. Circ. Amgen Biosimilar Ruling Raises IP Damages Risk (Law360-$)
• Jury Kills HIV Test Patent That PTAB Refused To Review (Law360-$)
• Veeva Looks To Widen Antitrust Claims Against IQVIA (Law360-$)
• Novartis Payments For Kymriah Treatment Logistics Avoid Kickback Concerns (Pink Sheet-$)
• Both Sides of the Coin in E.D. Pa. Comment k/Warnings Causation Opinion (Drug & Device Law)
• Congressional Caucus Working to Raise Personalized Medicine Awareness Among Legislators (GenomeWeb)

• FDA Advisory Committee Calendar
• 2020 DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients – 2-3 March 2020
• FDA/CDER-AACR-IASLC Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials – 28 February 2020

• Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008) (MHRA)
• Class 4 Medicines Defect Information: Oxylan Prolonged-release tablets, all strengths (oxycodone hydrochloride), (EL (20)/A12) (MHRA)
• New Indications For Diabetes Drugs Under The Spotlight At EMA (Pink Sheet-$)

• Proposed cess on import of APIs stokes supply disruption fears (Economic Times)
• MTaI members ready to brace up for any shortage of medical devices (Economic Times)
• CDSCO joins hands with QCI, AiMed to train medical device cos on product safety (Pharmabiz)

• Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products (Health Canada)

• Ferric carboxymaltose and low blood phosphorous (TGA)

• They Were Infected With the Coronavirus. They Never Showed Signs. (NYTimes)
• EU experts agree pushbacks at borders inappropriate to tackle virus (Reuters)
• U.S. CDC confirms 59 coronavirus cases, including repatriated citizens (Reuters)
• Warren, Bloomberg and Rivals Agree: Trump Is ‘Not Ready’ for Coronavirus (NYTimes)
• South Korea launches 'drive-thru' coronavirus testing facilities as demand soars (Reuters)
• Pentagon says may need additional funding to deal with coronavirus (Reuters)
• Iran's death toll from coronavirus reaches 26: health ministry (Reuters)
• Kuwait has 43 confirmed cases of coronavirus - health ministry (Reuters)
• Mexico to let cruise ship dock as crew member found to have flu, not coronavirus (Reuters)
• South Korea reports 505 new coronavirus cases, postpones military drill with US (Reuters)
• Swiss confirm three new coronavirus cases, now four in total (Reuters)
• Pakistan confirms first two cases of coronavirus, in travelers from Iran: minister (Reuters)
• Greece confirms first coronavirus case, a woman back from Milan (Reuters)
• Two more coronavirus cases in UK bring total to 15 (Reuters)
• Norway detects its first case of coronavirus (Reuters)
• Israel confirms coronavirus in man who returned from Italy (Reuters)
• Romania confirms first case of coronavirus: health minister (Reuters)
• Lebanon health ministry confirms third case of coronavirus, NNA reports (Reuters)
• Denmark confirms first coronavirus case in man returning from holiday in Italy (Reuters)
• Estonia reports first confirmed coronavirus case (Reuters)
• Bahrain discovers seven new coronavirus cases, raising the number to 33 (Reuters)