Recon: Sangamo Tanks on Weak Genome Editing Data; FDA Approves Sanofi Rare Blood-Clotting Disorder Drug

• Sanofi blood disorder drug wins FDA approval (Reuters) (FDA) (Press)
• Sangamo Therapeutics shares dive after poor early-stage trial data (Reuters) (Bloomberg) (STAT) (Endpoints) (Press)
• White House shakes up drug policy office (Politico)
• Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale (KHN)
• Congress invites 7 drugmakers to testify at potentially hostile hearing on drug prices. Here's what they're saying (CNBC)
• Eli Lilly, Novartis back US proposal on drug rebates to lower costs (Reuters 1, 2)
• Democrats Unite to Begin Push to Protect Pre-Existing Condition Coverage (NYTimes)
• Medicare Part D no match for runaway specialty drug costs: study (Reuters)
• Alphabet is taking on health care with a bunch of projects (CNBC)
• Solid Biosciences to soldier on as initial muscular dystrophy gene therapy results disappoint (STAT) (Endpoints)
• As magnitude and frequency of drug price hikes thaw, Express Scripts reports lowest increase in spending by commercial plans in 25 years (Endpoints) (BioCentury)
• Lawmakers revive Creates Act opposed by Big Pharma (Modern Healthcare-$)
• US Prosecutors Sue To Stop Nation's First Supervised Injection Site For Opioids (NPR)
• Stanford will investigate its role in the Chinese CRISPR baby debacle (MIT Technology Review)

• Europe’s vast new anti-bogus-drugs system will not find many (The Economist) (Pink Sheet-$)
• France's Sanofi targets growth from new drugs after stronger quarter (Reuters) (Financial Times) (Press)
• Sanofi punts 38 R&D projects to narrow pipeline focus (Fierce)
• ICH Seeks to Harmonize Generic Drug Standards (Focus)
• Vertex fears its triplet will also face UK reimbursement battle (BioPharmaDive)
• Pfizer ignores strike in Ireland as 900 employees' pensions affected (Pharmafile) (Fierce)
• Mundipharma launches Pelmeg biosimilar in Europe (PharmaTimes)
• Pharmacy stocks run low as Turkey's drug price policy hits supplies (Reuters)
• PhRMA Wants US-UK Trade Deal To Cover Regulatory Alignment (Pink Sheet-$)
• China says tests of possibly tainted medical product show no HIV (Reuters) (NPR)
• Measles Outbreak in Philippines Spreads Beyond Capital (NYTimes)
• Tens of thousands infected in measles outbreak in Madagascar (CNN)

• Pouring Billions Of Dollars Into Marketing Of Drugs (Forbes)
• Diabetes Moves Down the List of Priorities for Big Pharma (Bloomberg)
• Mega docking library poised to speed drug discovery (NIH)
• New York biotech debuts, targeting dormant metastatic cancer cells (STAT) (Endpoints)
• Biotech Insider Stock Sales: Peer Benchmarks And Guidelines (LifeSciVC)
• The Prescription Drugs That Rich People Buy (NYTimes)
• Precision medicine: Opening the aperture (McKinsey)
• Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds (Focus)
• FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder (Focus) (FDANews-$)
• FDA Finalizes Buprenorphine Drug Development Guidance (Focus)
• Study of PrEP and vaginal ring for HIV prevention begins in girls and young women (NIH)
• Azar: International Regulatory Harmonization Will Create More Stable Generic Markets (Pink Sheet-$)
• Pennsylvania hospital patient tests negative for Ebola (Reuters)
• Galapagos continues fibrosis pipeline buildout with Evotec deal (Fierce)
• Precision medicine’s rosy predictions haven’t come true. We need fewer promises and more debate (STAT)
• Antidepressants Can Interfere With Pain Relief Of Common Opioids (NPR)
• Doctors debate whether to stop calling low-risk tumors 'cancer' (Reuters)
• Dermatology patient advocacy groups may not disclose conflicts (Reuters)
• Tightening its wallet for a clinical comeback, Seres lets go of CSO and 30% of workforce (Endpoints)
• The biotech unicorns are back: Alector burnishes its $1.3B valuation in an IPO that generates $176M in cash (Endpoints) (Fierce)
• CRISPR restores expression in models of vision loss (Nature)

• Alnylam shores up enthusiasm for givosiran with early dataset ahead of crucial PhIII readout (Endpoints) (Press)
• Zogenix submits new drug application to FDA for Fintepla (PharmaTimes)
• Fasenra granted Orphan Drug Designation by FDA (PharmaTimes)
• Incyte Announces US FDA Has Extended the Review Period for Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease (Press)
• Altan Pharma Submits New Drug Application for Acetaminophen Solution for Infusion for Treatment of Pain and Reduction of Fever (Press)
• Arch Oncology Announces First Patient Dosed in Phase 1 Clinical Trial of AO-176, an Anti-CD47 Antibody with a Best-in-Class Profile (Press)

• FDA reports new cases of cancer linked to textured breast implants (NBC) (FDA)
• FDA's new draft guidance could hinder applications for digital combination products (mobihealthnews)
• Global Kinetics touts movement-monitoring study results (MassDevice)
• Smith & Nephew shares up on Q4, FY2018 results (MassDevice)
• FDA clears Current Health’s patient monitoring system (MassDevice)
• Orthofix Announces FDA Approval of the M6-C Artificial Cervical Disc to Treat Patients with Cervical Disc Degeneration (Press)
• Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device (Press)

• Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold (Focus)
• Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions (FDA)
• Biogen faces multibillion-dollar Tecfidera loss if Mylan wins latest patent threat (Fierce)
• The First Circuit Creates Havoc By Ignoring Facts And An Elephant In The Room (Drug & Device Law)
• USPTO Releases Performance and Accountability Report for FY 2018 (Patent Docs)
• Drugmaker Files Ch. 11, Blames Low-Selling Urination Drug (Law360-$)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Ireland Asks Companies to Proactively Discuss Possible Effects of Brexit (Focus)

• China issues more overseas medical device and drug inspection regulations (Pacific Bridge Medical)
• Korea to allow use of direct to consumer (DTC) devices for some genetic testing (Pacific Bridge Medical)

• Australia Considers Changes To Bioequivalence Requirements For Foreign Comparators (Pink Sheet-$)
• Consultation: Reforms to the generic medicine market authorisation process (TGA)
• Publication of interim decisions amending, or not amending, the current Poisons Standard, February 2019 (TGA)