Recon: FDA Grants Accelerated Approval for Karyopharm’s Xpovio

• FDA approves new multiple myeloma drug despite toxicity concerns (STAT) (FDA) (Press)
• Stem-cell biotech seeing strong growth (STAT)
• Oklahoma portrays J&J as opioid crisis 'kingpin' in court battle (Politico)
• Opioid drug defendants ask Oklahoma judge to end case (CNBC)
• HHS gets a new HIV prevention patent, but will the agency demand royalties from Gilead? (STAT) (Pharmafile)
• States agree to pause lawsuits against bankrupt opioid maker Insys (Reuters) (Endpoints) (Law360-$)
• FDA puts Unum T cell therapy trial on hold after adverse events (Fierce) (Endpoints)
• Zolgensma set a new drug pricing bar. Insurers show some signs of pushback (BioPharmaDive)
• California broadens investigation of doctors for issuing questionable vaccine exemptions (NBC)
• DOJ pushes Congress to permanently close loophole for knock-off fentanyl (CBS)
• New Weapons Against Cancer: Millions of Bacteria Programmed to Kill (NYTimes)
• Dementia Discovery Fund Adds Biotech Investor Behr as Partner (WSJ)

• GSK's HIV drug Dovato receives EU marketing nod (Reuters) (PharmaTimes)
• Just how much would no-deal Brexit harm biomedical science? Researchers speak out (Endpoints)
• Roche says one-dose Xofluza flu drug as good as older Tamiflu in kids (Reuters) (Endpoints) (Press)
• Mundipharma picks up rights to Herceptin biosimilar Tuznue (PharmaTimes)
• NICE approves CDF funding for Sanofi's Libtayo (PharmaTimes)
• UK: NICE Seeks Views On Using RWD To Inform Guidance (Pink Sheet-$)
• Ebola outbreak demonstrates science’s need to ‘nudge’ (Financial Times)
• The Zika Virus Is Still a Threat. Here’s What Experts Know. (NYTimes)

• Cancer’s $94 Billion Annual Hit To The U.S. Economy (Forbes)
• Oncologists are guardedly optimistic about AI. But will it drive real improvements in cancer care? (STAT)
• Purdue hires Ducharme as CSO to aid expansion beyond opioids (Fierce)
• Will the Pharma Space Witness More Mega-Merger Deals in 2H? (Yahoo)
• Pharma takes Wi-Fi targeting to the doctor's office to reach waiting patients on their smartphones (Fierce)
• Biosimilars Council Says Patent Abuse Chills Competition, Costs Billions (FDA News-$)
• As Washington Waits On Pricing Proposals, A Call For A Reset In R&D Debate (Pink Sheet-$)
• US FDA CBER Chief Calls For Industry-Academia Collaboration In Developing Treatments For Ultra-Rare Diseases (Pink Sheet-$)
• Why ‘Established Conditions’ CMC Approach Could Generate More Supporting Information, Not Less (Pink Sheet-$)
• Prevnar 13 Loses ‘Routine’ Endorsement For Older Adults In CDC Panel Vote (Pink Sheet-$)
• Dengvaxia’s Restrictive Indication Will Make Immunization Recommendations Difficult, ACIP Members Say (Pink Sheet-$)
• Do exec departures portend clinical disasters? Analyst counts the examples (Endpoints)
• Epidermolysis Bullosa: FDA Seeks to Help Development of New Treatments (Focus)
• Attempt to replicate clinical trials with real-world data generates real-world criticism, too (STAT)
• Merck abandons $7M in grants for long-term IT hiring plan in Austin (Fierce)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate (FDA)

• Going for it: GSK’s Hal Barron outlines a big PhIII program for rheumatoid arthritis — going head-to-head with giant rivals (Endpoints)
• Puma Biotechnology Presents Interim Results from the Biliary Tract Cohort of its Phase II SUMMIT Basket Trial of Neratinib at the ESMO World Congress on Gastrointestinal Cancer 2019 (Press)
• Boston Biomedical's lead drug fizzles in difficult-to-treat pancreatic cancer (Endpoints)
• VALBIOTIS Announces Positive Results From the Phase IIA Clinical Study of VALEDIA®, Now the First Product Proven Effective in People With Prediabetes (Press)
• Akero Therapeutics Announces Dosing of First Patient in Phase 2a Study of AKR-001 to Treat NASH (BALANCED) (Press)
• RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia® (Press)
• Perrigo Announces FDA Final Approval and Launch Of The AB-rated Generic Version Of Metrogel-Vaginal® Gel (Press)

• Lawmakers Question FDA on Conditional Approvals of Devices (Focus)
• Edwards Lifesciences Recalls Devices After 3 Deaths Reported (Focus)

• 'Extraordinary' $100M Fraud Gets Ex-Pharma CEO 30 Years (Law360-$)
• Booker returns pharma executive's money after he claimed he hadn't accepted any (ABC)
• Md.'s Prescription Drug Affordability Board an example for America (Baltimore Sun)
• Another court sides with Trump in Title X case (Politico)
• D. Kansas Stays Discovery in Breast Implant Case Because of Pending PMA Preemption Motion (Drug & Device Law)
• Feds, Drugmakers Grilled Over Rule Mandating Prices In Ads (Law360-$)
• Antares Pharma Escapes Fraud Suit Over Drug Statements (Law360-$)
• NYC Doc Convicted In $2M Opioid Scheme Gets 5 Years (Law360-$)

• FDA Advisory Committee Calendar

• Ursula von der Leyen nominated for EU President role (PMLive)
• Clinical trials for medicines: manage your authorisation, report safety issues (MHRA)

• US biotechs to start parallel approvals in China (PharmaLetter-$)

• Advertising health products: Rules about safety claims in advertising (TGA)

• Notice: Regulatory Enrolment Process (REP) Pilot for Veterinary Drugs (Health Canada)

• MSF asks member-countries to withdraw damaging provisions from RCEP free-trade agreement (PharmaBiz)
• Biosimilars are coming to LATAM (PharmaManufacturing)