Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

• Senator asks two pharma CEOs to clarify discrepancies in recent testimony about drug samples (STAT)
• The Family That Profited From the Opioid Crisis (NYTimes)
• Alex Azar's confusing claim on Medicaid work requirements (Politico)
• Grassley on the President's 2020 Budget W/ HHS Sec. Azar (Senate Finance)
• An ICU staple has exponentially spiked in price. Can compounding solve that problem? Now the courts will decide (STAT)
• FDA delays Karyopharm PDUFA to review extra information (Fierce)
• Scott Gottlieb to biopharma: You wanted us to help modernize R&D, now go out and do it (Endpoints)
• Spectrum yanks marketing application for Neulasta rival after FDA demands more data (Endpoints)
• FDA allows marketing of new device to help treat carbon monoxide poisoning (FDA)

• WHO says Ebola area contained but Congo needs long-term support (Reuters)
• Roche clinches EU approval for MabThera in rare autoimmune indication (Endpoints) (Pharmafile) (Press)
• The world’s top 10 blockbusters — and what they tell us about R&D trends (Endpoints)
• US Visa Concerns Led ICH To Choose Canadian Meeting Site (Pink Sheet-$)
• More trouble for Samsung BioLogics: Prosecutors raid Korea Exchange in IPO probe (Fierce) (Endpoints)
• Pharma Uncertainty Remains As UK Votes To Delay Brexit (Pink Sheet-$) (EPR)
• MHLW to Draw Up Guidelines on Registry Data Use for Submissions: Clinical Innovation Network Initiative (PharmaJapan)
• Analysts: Keytruda has a blockbuster market not factored into Merck’s forecasts—China (Fierce)
• UK Closes Investigation Into Anti-Competitive Scheme With Remicade (Focus)

• Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance (Focus)
• FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders (Focus)
• Ex-Pfizer CEO Ian Read sees 2018 pay slashed by a third as incentive package plummets (Fierce) (Endpoints)
• Call For CRISPR Moratorium Echoes Early Days Of Gene Therapy (Forbes)
• ​Health Care Chutzpah vs. Health Plan Literacy (CMPI)
• New Study Says Breast Cancer Is 11 Different Diseases, Allowing Researchers To Predict Relapse (Forbes)
• J&J chief Gorsky took a big pay hit in 2018 but still nabbed $20M (Fierce)
• Surrozen banks $50M round to fuel its drive to the clinic with regenerative med platform (Endpoints)
• Desperately seeking a turnaround, beleaguered veteran fund manager Woodford hits out at critics, fake news (Endpoints)
• Transforming Medical Affairs: Tapping the alchemy of storytellers and digital start-ups (McKinsey)
• Update on Valsartan “Priority” Review (Lachman Consultants)

• Adamis Pharmaceuticals Announces FDA Acceptance for Review of the New Drug Application of Its Higher Dose Naloxone Injection Product Candidate (Press)
• Bayer's Phase III Clinical Trial Of Nifurtimox In Pediatric Patients With Chagas Disease Meets Primary Endpoint (Press)
• Sutro Biopharma Initiates Phase I Clinical Trial of STRO-002 for the Treatment of Ovarian and Endometrial Cancers (Press)
• Soleno Therapeutics Announces Positive Outcome from Planned Data Safety Monitoring Board Review of Phase III DESTINY PWS Clinical Trial of DCCR in Prader-Willi Syndrome (Press)
• Xeris Pharmaceuticals Doses First Patient in Phase 2 Trial Evaluating Its Ready-to-Use Glucagon to Address Exercise-Induced Hypoglycemia (Press)
• ImmunogenX Initiates Phase 2 Trial for its Lead Therapeutic and Diagnostic Candidates Latiglutenase and CypCel (Press)

• Exactech wins FDA nod for Alteon Cup, XLE liner acetabular system (MassDevice)
• FDA Grants Breakthrough Device Designation to Fresenius Medical Care North America's Software for Fluid Management During Hemodialysis (Press)
• Abbott Receives FDA Approval for Expanded Indication for MitraClip™ Device (Press)
• Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices (MassDevice)
• Fresenius wins FDA breakthrough device nod for fluid management software (MassDevice)
• Oberd launches AI-assisted tech for gathering outcome data (MassDevice)
• Stryker Buys Israeli Med Tech Co. In Deal Worth Up To $220M (Law360-$)
• CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders (Focus)
• CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials (Focus)

• Tobacco and E-Cigarette Lobbyists Circle as FDA Chief Exits (NYTimes)
• Medtronic’s Covidien Agrees to $20M DOJ Settlement Over Kickback Allegations (Focus)
• Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet Form (FDA Law Blog)
• Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets (Pink Sheet-$)
• Plaintiff Loses in a Game of “What If …” (Drug & Device Law)
• Bayer Must Face Essure Stillbirth Suit, 4th Circ. Rules (Law360-$)
• Attys In Opioid Suits Are Holding Big Pharma Accountable (Law360-$)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: UK Industry and Lords Criticize No-Deal Preparations (Focus)
• EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation (Focus)

• Chi-Med in ‘prime position’ to take advantage of Chinese growth (InPharmaTechnologist)
• Improper Handling of Personal Information of Blood Donors (HSA)
• Nicox signs licensing deal for Zerviate in China (PharmaLetter-$)

• Health Canada Begins Release of Clinical Data on Drugs and Devices (Focus)

• Breast cancer risk tied to DDT varies by exposure timing (Reuters)