Recon: Schumer Calls for $8.5B for Coronavirus Response; Takeda Buys PvP in $330M Deal

• White House considers appointing coronavirus czar (Politico)
• Schumer Requests $8.5B for Coronavirus Response (Senate)
• Trump will hold White House news conference on coronavirus on Wednesday (Reuters)
• Candidates attack Trump on coronavirus (Politico)
• First US Testing Begins for Potential Coronavirus Treatment (WSJ)
• GoodRx Saves Money on Meds, Also Shares Data With Google, Facebook (Consumer Reports)
• Judge rules trial sponsors must publish decade’s worth of missing data (STAT) (Endpoints)
• An FDA program to ensure decades-old drugs finally get approved is costing billions in price hikes (STAT)
• Theft victim or data bully? IQVIA exchanges blows with small rival it says destroyed evidence in legal fight (Endpoints)

• Takeda buys PvP in $330M deal to bag a second celiac drug (Fierce) (Endpoints) (PMLive) (Press)
• New coronavirus cases outside China exceeded those in China for the first time, WHO says (CNBC)
• Second Novartis Witness Says Politicians Bribed, But Knows Nothing (National Herald)
• Sandoz to keep prices stable on coronavirus-relevant drugs (Reuters) (BioPharmaDive)
• MHLW Orders Label Revisions for 9 Hep C Drugs (PharmaJapan)
• NICE rejects Roche's new cancer med Polivy on lack of long-term evidence (Fierce)

• Repurposing Drugs to Fight Cancer (NYTimes)
• The FDA in the 2020s: move forward, don’t stand still (STAT)
• Amgen heart drug passes interim check, setting up year-end readout (BioPharmaDive)
• Tying basic science to spinouts, Dana-Farber debuts sister funds totaling $126M with MPM Capital (Endpoints) (Fierce)
• Amarin aims for Vascepa boom with doubled sales force nearly in place (Fierce)
• Go or no go? Ozanimod and Fintepla await FDA verdicts (Evaluate)
• IMV preps pivotal trials for ovarian cancer T cell therapy (PMLive)
• Norbert Winkeljohann to succeed Werner Wenning as Chairman of Bayer’s Supervisory Board (Press)
• The Quality Lowdown: On Redeploying Inspectors, API Suppliers Thanks To Coronavirus (Pink Sheet-$)
• Continuous Manufacturing: Cost, Lack Of Know-How Have Deterred Generic Firms, Prof Says (Pink Sheet-$)
• Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny (Pink Sheet-$)
• The Return on Investment (ROI) on PBM Services (Visante)
• Will a 'risk-off' mindset hasten cell therapy M&A? Iovance surges on buyout chatter (Endpoints) (Fierce)
• One less rival for Immunovant, as Alexion abandons FcRn inhibitor (Endpoints)
• Lack of measles shot sets stage for lethal complications (Reuters)
• Tracking pharmaceuticals in the supply chain remains difficult due to sloppy paperwork (STAT)
• Will the newest pill for HIV prevention fuel progress — or profits? (STAT)
• In at least one life-sci hub, gender and diversity initiatives haven’t made a dent (Endpoints)
• Microbiome Q&A: New study maps the vagina's 'optimal microbiota' — and its implications for biopharma (Endpoints)
• An Examination of Emerging Bioethical Issues in Biomedical Research: A Workshop (National Academies)
• Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D) (FDA)

• Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer (Press)
• Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer (Press)
• Alnylam Announces Approval in Brazil of ONPATTRO® for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy (Press)
• Vanda Pharmaceuticals shares in the red as skin disease test fails (Fierce) (Press)
• Translate Bio Receives FDA Fast Track Designation for MRT5005 for the Treatment of Cystic Fibrosis (Press)
• Cyclo Therapeutics Announces Completion of Enrollment in its Extension Protocol to the Phase I Trial to Evaluate Trappsol® Cyclo™ for the Treatment of Niemann-Pick Disease Type C (Press)
• Senseonics Announces the FDA Approval to Continue the PROMISE Sensor Clinical Study in an Extended Cohort to 365 Days to Gather Feasibility Data (Press)

• CDRH Misses All Kinds of Goals (FDA Law Blog)
• LivaNova beats on Q4 earnings, misses on revenue (MassDevice)
• LivaNova gets nod for heater-cooler device changes to cut contamination risk (MedtechDive) (Press) (FDA)
• Guardant predicts net loss doubling as it takes on Exact Sciences' Cologuard (MedtechDive)
• Analysis casts doubt on Boston Scientific TAVR embolic protection device (MedtechDive)
• Tandem shapes FDA strategy for new insulin pump features (MedtechDive)
• Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles (FDA)

• Why prescription drug costs are big issue for South Carolina voters (CBS)
• Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought By Walgreens, Kroger (Center for Biosimilars)
• Juul Faces 39-State Probe of E-Cigarette Marketing to Teens (Bloomberg) (AP)
• Review of the FY2021 Budget Request for HHS (Senate Appropriations)
• Contract offers unprecedented look at Google deal to obtain patient data from the University of California (STAT)
• Proposed Fiscal Year 2021 Budget With Health And Human Services Secretary Azar (House Ways and Means)
• Endo touts financial 'flexibility' as massive opioid settlements mount industrywide (Fierce)
• Big Pharma and politics in an election year: Ad spending soars in efforts to influence the influencers (Fierce)
• New York Holds that Registration to do Business does not Constitute Consent to General Personal Jurisdiction (Drug & Device Law)
• Fresenius Loses ‘Unduly Speculative’ Generic Drug Row (Law360-$)
• Ark. Tells High Court ERISA Doesn't Nullify Drug-Payment Law (Law360-$)
• Allergan Inks $51M Deal To End Direct Buyers' Restasis Suit (Law360-$)
• Feds Say Insys' Kapoor Should Be On Hook For $60M Tab (Law360-$)
• Drug Approval Law Will Likely Deter Pharma Delay Tactics (Law360-$)

• FDA Advisory Committee Calendar
• An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus – 3 March 2020

• EU Call For Coronavirus Projects Sparks Big Pharma Interest (Pink Sheet-$)
• Scottish parliament approves free sanitary products for all women (Reuters)
• Emerade adrenaline pens recalled from consumers (Fimea)

• China CMDE publishes guidance on generic medical device names (Emergo)

• Stents price capping has improved its accessibility: Drug pricing regulator NPPA (Economic Times)
• DCGI clarifies no separate new drug approval required for drug if first time used in approved FDC (Pharmabiz)
• USFDA issues warning letter to Cipla for Goa manufacturing facility (Economic Times)

• Independent review of the reforms to the therapeutic goods advertising framework to commence (TGA)

• Three more Chinese regions lower emergency response level as virus threat recedes (Reuters)
• Mainland China reports 406 new cases of coronavirus on February 25, deaths up by 52 (Reuters)
• China rolls out fresh data collection campaign to combat coronavirus (Reuters)
• EU calls for coordinated European response to coronavirus (Reuters)
• UK conducts random coronavirus testing as part of early warning plan (Reuters) (PHE)
• China's blood donations dry up as coronavirus outbreak quells giving (Reuters)
• Brazil confirms first coronavirus case in Latin America: source (Reuters)
• France reports second coronavirus death: health official (Reuters)
• Kuwait says total of 25 coronavirus cases confirmed: KUNA (Reuters)
• Greece confirms first coronavirus case (Reuters)
• US soldier infected as South Korea coronavirus cases rise above 1,260 (Reuters)
• Swiss authorities confirm first case of coronavirus (Reuters)
• San Francisco declares emergency over coronavirus (Reuters)
• Lebanon health ministry confirms second case of coronavirus (Reuters)
• 12th person dies in northern Italy of coronavirus: official (Reuters)
• Austria seals off Innsbruck hotel after reporting first two coronavirus cases (Reuters)
• New coronavirus cases in Germany, one man in critical condition (Reuters)
• Elderly man in Tokyo dies after catching new coronavirus: NHK (Reuters)

• Cystic fibrosis medicine Kalydeco now available in New Zealand (PharmaLetter-$)

• This CEO running clinics for Apple and Facebook wants to ‘flip’ the primary care model (STAT)