Recon: BMS Reports Long Term Results for Opdivo in Kidney Cancer; Cancer Drug Shortages Hit Mexico’s Public Health System

• DOJ’s Generic Drug Criminal Probe Snares Ex-Sandoz Exec (Law360-$) (DoJ)
• BMS unveils long-term results for Opdivo in kidney cancer (PMLive) (Press) (Press)
• N-of-1 drugs push biopharma frontiers (Nature)
• A city in Georgia is the latest to sue Mallinckrodt over its pricey Acthar Gel medicine (STAT)
• Solving the mystery of Vifor’s new voucher (Vantage) (Press)
• Grassley Expects Prescription Drug Bill to Pass by May 20 (Senate Finance) (The Daily Iowan)

• China will build a complete epidemic emergency response system: CCTV (Reuters)
• China reports 105 new deaths from coronavirus on mainland on Feb. 16 (Reuters)
• More than 80 clinical trials launch to test coronavirus treatments (Nature)
• Drug Shortage in Mexico Piles Woes on Cancer-Stricken Children (WSJ)
• The WHO Knows Insulin Is Too Expensive. How It Plans To Drive Down The Price (NPR)
• SMC enables access to Kyowa Kirin’s Crysvita for rare bone disease (PMLive)
• After FDA refusal, Takeda builds case for subcutaneous Entyvio (PMLive)
• 99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms (Medtech Insidght)

• Next-generation influenza vaccines: opportunities and challenges (Nature)
• January 2020 Generic Approvals Well Below Average (Lachman)
• How FDA is Putting the Patient Voice at the Forefront of Gene Therapy Clinical Trials for Hemophilia (FDA)
• Electronic Submission of Biological Product Deviation Reports (eBPDR) (FDA 1, 2)
• Digital therapeutics and pharma: A blueprint for success from Sanofi’s Bozidar Jovicevic (McKinsey)
• Life after opioids: 'We have not served our patients well' (The Guardian)
• Agile Therapeutics Wins FDA Nod for Twirla Contraceptive Patch (Xconomy)
• The FDA Needs to Set Standards for Using Artificial Intelligence in Drug Development (The Helath Care Blog)

• Eisai Announces Latest Data for LENVIMA® (lenvatinib) in Combination with Everolimus for Advanced Non-Clear Cell Renal Cell Carcinoma (Press)
• Sensorion Receives Ethics Committee Approval to Include New Military Sites in SENS-401 Phase 2 study (Press)
• Viriom to present results of Phase I study of the long acting injectable formulation of novel NNRTi for treatment of HIV-1 infection at CROI 2020 (Press)
• PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer (Press)

• Dexcom hopes wave of new customers offsets lower prices, Abbott's sweet spot (MedtechDive)
• Dexcom skyrockets on Street-beating Q4 (MassDevice)

• AdvaMed, state AGs weigh in ahead of EPA sterilization rule (MedtechDive)
• Appeals Court Rejects Trump Medicaid Work Requirements in Arkansas (NYTimes)
• Senate Democrats pressure Trump to drop ObamaCare lawsuit (The Hill)
• Israeli Drugmaker Can Intervene In $163M Perrigo-US Row (Law360-$)
• Endo Shareholders' Price-Fixing Claims Can't Sway Judge (Law360-$)
• Stryker Unit Seeks Ax Of Acantha's IP Marking Failure Suit (Law360-$)
• Life Sciences Court Report (Patent Docs)
• Eastern District of Pennsylvania Chimes in with Another Comment k Abomination (Drug & Device Law)
• Petition Requesting that FSIS Declare Thirty-One Salmonella Serotypes Adulterants in Meat and Poultry (FDA Law Blog)

• FDA Advisory Committee Calendar
• Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards – 19 February 2020

• 120,000 patients ‘left in the dark’ over cancer treatment (PharmaTimes)
• Taking multiple medicines? Support the Yellow Card scheme by reporting suspected side effects (MHRA)
• Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection, PL 20075/0675, (EL (20)A/09) (MHRA)

• Asia Deal Watch: Strides Obtains 18 US ANDAs From Pharmaceutics (Scrip-$)
• Indian pharma keen on WHO policy brief for medicine traceability to stall warning letters from regulators & remain unscathed (Pharmabiz)
• Ficci: Some drugs may not last beyond Feb because of virus crisis (Economic Times)
• Unichem, Macleods Pharma recall drugs from US market (Economic Times)
• Amid Coronavirus outbreak, India mulls export ban on 12 essential drugs (Economic Times)
• Covid-19 Impact: Pharma companies feel the pain as prices of key inputs shoot up (Economic Times)

• China's finance ministry issues $1.2 billion in funds for epidemic control efforts (Reuters)
• Hundreds of Americans flown home from cruise ship, 14 with coronavirus (Reuters)
• U.S. health officials to start testing for coronavirus in five states (Reuters)
• Update on COVID-19 in the Eastern Mediterranean Region (WHO)
• France Confirms First Death in Europe From Coronavirus (NYTimes)
• Taiwan confirms first coronavirus death on island, cases at 20 (Reuters)
• Thailand reports new coronavirus case, to increase entry screening (Reuters)
• Scramble to track Cambodia cruise passengers after coronavirus case reported (Reuters)
• Australia to evacuate more than 200 citizens from cruise ship quarantined at Japan port (Reuters)
• Additional 99 virus infections confirmed on cruise ship in Japan: reports (Reuters)
• PAHO prepares a further 9 countries in the Americas for laboratory diagnosis of new coronavirus (PAHO)
• Japanese man diagnosed with coronavirus after visiting Hawaii (Reuters)

• Patients often puzzled by medical test reports (Reuters)