Recon: FDA Approves BMS’ Liver Cancer Combo; Lawmakers Press FDA, Pharma on Supply Chains

• FDA approves Bristol Myers' liver cancer therapy  (Reuters) (Press)
• Lawmakers pressure Big Pharma on drug supply chains amid coronavirus outbreak (CNBC)
• Coronavirus Spurs US Efforts to End China’s Chokehold on Drugs (NYTimes)
• Insulin Costs May Be Capped in a Medicare Program (NYTimes) (Reuters) (STAT)
• White House says has sent 'principles' for drug pricing reform to Congress (Reuters)
• CDC developing serologic tests that could reveal full scope of US coronavirus outbreak (STAT)
• Coronavirus fears may slow clinical trials and delay regulatory steps (STAT)
• Closely watched opioid trial in New York postponed due to coronavirus (Reuters)
• FDA rejects Intarcia’s diabetes implant for a second time (STAT) (Endpoints)
• US coronavirus testing threatened by shortage of critical lab materials (Politico) (STAT)
• CDC's Redfield: 4,856 people tested for coronavirus in US public health labs (Reuters)

• 'Whatever It Takes': EU in Show of Unity on Virus, but With Scarce Resources (Reuters)
• Italy, Britain wield economic axes to try to slay coronavirus (Reuters)
• Italy to ramp up spending on coronavirus, further restrictions possible (Reuters)
• Some in Wuhan told to go back to work as new cases of coronavirus subside in China (Reuters)
• China's coronavirus-induced supply chain woes fan concerns of possible drug shortages (Reuters)
• Regeneron, Sanofi to Test Arthritis Drug as Coronavirus Treatment (WSJ)
• French group Biomerieux launches three coronavirus tests (Reuters)
• Global companies expand the reach of their cancer drugs in China (STAT)
• The global top 50 biopharma companies (Endpoints)
• Ten drugs in pre-registration likely to be blockbusters by 2025, finds report (EPR)
• Thrombocytopenia patients set to get Mulpleo after UK launch (PharmaTimes)

• Trump calls emergency meeting with top health officials at White House, top lawmaker says (CNBC)
• As pressure for coronavirus vaccine mounts, scientists debate risks of accelerated testing (Reuters)
• Coronavirus response hurt by lack of funding for public health labs, CDC director tells Congress (CNBC)
• ‘It’s Just Everywhere Already’: How Delays in Testing Set Back the US Coronavirus Response (NYTimes)
• Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (CDC)
• Coronavirus Cases In The US Surpass 1,000 Mark (NPR)
• US officials to urge 'aggressive' local steps against coronavirus (Reuters) (Reuters)
• Another coronavirus vaccine is in the works in Maryland labs (Baltimore Sun)
• ‘Containment Area’ Is Ordered for New Rochelle Coronavirus Cluster (NYTimes)
• Massachusetts declares emergency as coronavirus cases more than double overnight with 51 new infections (CNBC)
• First Coronavirus Death in New Jersey: Yonkers Raceway Worker (NYTimes)
• South Korea reports jump in coronavirus cases after call center outbreak (Reuters)
• Australia unveils $1.6 billion health package to combat coronavirus (Reuters)
• Italy passes 10,000 coronavirus cases as national quarantine moves closer to total shutdown (CNBC)
• Italian coronavirus deaths jump 36% to 631 (Reuters)
• Albanian woman, 73, dies of coronavirus (Reuters)
• Iranians told to stay at home as coronavirus death toll rises to 354 (Reuters)
• Turkey confirms first coronavirus case, wins WHO praise for vigilance (Reuters)
• Germany confirms third death related to coronavirus (Reuters)
• Madrid region reports new jump in coronavirus cases (Reuters)
• Japan had 59 new coronavirus cases Tuesday, biggest one-day rise: NHK (Reuters)
• Philippines reports 16 new confirmed coronavirus cases (Reuters)
• Ten more coronavirus cases in Ireland bring total to 34 (Reuters)
• Honduras confirms its first two cases of coronavirus: health ministry (Reuters)
• Panama reports first coronavirus death, seven more people infected (Reuters)
• Malaysia tracking 5,000 people possibly exposed to coronavirus at religious event (Reuters)
• PhRMA closes its D.C. headquarters after visitor tests positive for coronavirus (STAT)
• Biogen outbreak now tied to 70 cases of coronavirus as state total more than doubles in 1 day (Endpoints)
• With WuXi and Alnylam in tow, Vir enlists NIH as it tests various tools to fight the coronavirus scourge (Endpoints)
• US may see blood shortages as coronavirus cancels office blood drives (Reuters)

• Drug companies, Canadians, pharmacists, and more blast Trump’s drug importation plan (STAT)
• Disparities in childhood cancer survival biggest for most-treatable tumors (Reuters)
• Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction? (Harvard Bill of Health)
• Bayer and MassBio teach startups regulatory ins and outs at new center (Fierce)
• Analysts start to sort out which biopharma companies’ R&D plans are most threatened by a pandemic (Endpoints)
• Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date? (Scrip-$)
• Gilead/Galapagos, Intercept and Corbus trials could be hit by coronavirus spread: analyst (Fierce)
• A JP Morgan promise, a last-minute bid and the coronavirus stock market — how Gilead’s Daniel O’Day nabbed Forty Seven (Endpoints)
• ViiV, UNC-Chapel Hill renew HIV partnership for another five years (PharmaTimes)
• Silverback Therapeutics gets $78M boost to 'reconceptualize' antibody-drug conjugates (Endpoints)
• New CEO takes over as Fujifilm Diosynth Biotechnologies expands (Fierce)
• Tackling drug shortages with data, AI, legislation, and more (STAT)
• Is HKEX ready to return to biotech business? InnoCare tests waters with hopes to fetch $257M in IPO (Endpoints)
• In search of a Kuur: Cell Medica rebrands and regroups, taking a new name, a new CEO and new money (Endpoints)
• Epilepsy drug Xcopri gets Schedule V designation from DEA (PharmaLetter-$)
• Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Reopening of the Comment Period (FDA)
• Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability (FDA)

• Janssen Announces FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer (Press)
• Spectrum Pharmaceuticals to Present Data from Phase 2 Clinical Trial for Poziotinib at Upcoming Medical Conference (Press)
• Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study (Press)
• MedDay Reports Top-Line Data from Phase III Trial “SPI2” for Treatment of Progressive Forms of Multiple Sclerosis (Press)

• ECRI: Poor sterilization, failure to learn from device problems threaten patient safety (MedtechDive)
• Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention (Press)
• FDA updates guidance on 510(k) submissions for electrosurgical devices (MedtechDive)
• Medical device companies continue to scale back sales projections amid coronavirus (MassDevice)
• Smiths Medical warns on LogiCal blood sampling system sets (MassDevice)
• Rival to Boston Scientific device used in TAVR wins CE mark (MedtechDive)
• Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D (FDA)
• BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules (FDA)

• Mylan Wins Court Ruling Tossing Sanofi Diabetes Drug Patent (1) (Bloomberg)
• Lessons Learned From Remicade Biosimilar Patent Row (Law360-$)
• Justices Urged To Allow Patents For Selective Use Of Meds (Law360-$)
• Biosimilar Incentives: US Senate Republicans ‘Leery’ Of Out-Of-Pocket, Shared Savings Policies (Pink Sheet-$)
• NDNY Dismisses IVC Failure to Warn and Fraud Claims (Drug & Device Law)
• Affirmative Defenses: What’s Going to Stick to the Wall? (FDA Law Blog)
• National Biodefense Strategy: Opportunities and Challenges with Early Implementation (GAO)
• The National Comprehensive Opioid, Stimulant, and Substance Abuse Program Forum Presents Ways to Combat Addiction Crisis (DOJ)
• Principal Deputy Assistant Attorney General Katharine T. Sullivan Speaks at the Comprehensive Opioid Abuse Program National Forum (DOJ)

• FDA Advisory Committee Calendar

• Watchdog told to review evidence against Pfizer and Flynn (Financial Times)
• UK Firms Want Govt's Budget To Spell Out Pro-Industry Measures (Pink Sheet-$)
• Class 4 Medicines Defect Information: Aripiprazole 1mg/ml Oral Solution, PL 04569/1667, (EL(20)A/15) (MHRA)

• Gilead's China Remdesivir Patents Confirmed, Generics Firms Cautioned (Scrip-$)
• COVID-19 outbreak triggers regulatory interventions in Asia-Pacific region (Emergo)

• Sharing data of coronavirus on daily basis has created panic in country: IMA (Economic Times)

• TGA to expand quality audits for medicinal cannabis (TGA)