Recon: FDA Approves Sanofi, Regeneron’s Dupixent to Treat Nasal Polyps, Alexion’s Soliris for Rare Autoimmune Disease

• Five Things We Found In The FDA’s Hidden Device Database (KHN)
• FDA approves Alexion’s Soliris as first treatment for neuromyelitis optica spectrum disorder (FDA)
• FDA clears Dupixent as first-ever drug for nasal polyps (PMLive) (Endpoints) (Reuters) (FDA) (Press)
• Future is in doubt for cheaper versions of biologic drugs (NBC)
• Bruised by Wall Street, Ovid may be one step closer to vindication with rare disease drug (STAT)
• Lawmakers press Gilead for pricing info on the Truvada HIV prevention pill (STAT) (Fierce)
• Google and the University of Chicago Are Sued Over Data Sharing (NYTimes) (STAT)
• Senate Committee Advances Health Cost Bill With Changes Impacting FDA (Focus) (STAT) (NYTimes)
• ImmunoGen to lay off 220, as it pushes ahead with troubled drug (BioPharmaDive) (Endpoints)
• Why Transparency on Medical Prices Could Actually Make Them Go Higher (NYTimes)
• Drugmaker challenges FDA on animal testing (The Hill)
• Democratic debate reveals health care fractures (Politico) (Reuters) (STAT)
• Apple continues expanding into health care by selling its first diabetes product in stores (CNBC)
• ANNOUNCE prompts questions over the Accelerated Approval process (Nature)

• Negotiating drug prices without restricting patient access: lessons from Germany (STAT)
• WHO study finds ‘strong evidence’ HPV vaccine can prevent cervical cancer (CNBC) (Reuters)
• AstraZeneca challenges Roche on frontline SCLC after seizing an interim win — and Merck may not be far behind (Endpoints) (Pharmafile) (Press)
• UK Pharma Decries Govt's Latest No-Deal Brexit Planning (Pink Sheet-$)
• Bayer shares jump as it reviews legal strategy on weedkiller (Financial Times)
• Pharma frustration mounts as Johnson toys with no-deal Brexit pronouncements (PMLive)
• Titan Therapeutics' opioid dependence implant Sixmo approved in Europe (Pharmafile)
• NICE hops on real world data trend to inform guidance (PharmaTimes)
• $450m diagnostics sale will fuel more Syncona biotech funding (PMLive)
• EU Council Calls For More Action On Developing New Antimicrobials (Pink Sheet-$)
• Conditions Converging For More M&A In Korean Pharma, Biotech (Scrip-$)

• This CEO is trying to genetically modify pig organs for human transplant and turn more Sci-Fi ideas into common cures (CNBC)
• CBD is all the rage among patients. It’s launching their physicians into uncharted territory (STAT)
• U.S. advisory panel stops short of broad recommendations for two common vaccines (STAT) (NBC)
• FDA Plots Shift Away From CSR Pilot to Forge New Transparency on Drug Approval Process (Focus)
• FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines (Focus)
• FDA officials see 'missed opportunity' with patient outcomes in clinical trials (BioPharmaDive)
• Zogenix plans quick return to the FDA with their spurned application on Dravet syndrome drug — shares spike (Endpoints)
• BridgeBio takes crown for biggest biotech IPO of 2019, as fellow unicorn Adaptive raises offering size and price (Endpoints) (Xconomy)
• OncoSec signs on Dana-Farber as CAR-T partner; Dova racks up another Doptelet approval (Endpoints)
• US FDA’s Higher Bar For Postmarketing Pregnancy Studies Shown By AMAG’s Vyleesi, Sprout’s Addyi (Pink Sheet-$)
• James Noble is taking his last lap at the biotech he founded and saved. It's Adrian Rawcliffe's turn now (Endpoints)j
• Targeting toxic protein aggregation, German biotech banks €12M to develop drug for rare neurodegenerative disorder (Endpoints) (Fierce)
• Beefing up its new gene therapy unit, Catalent inks $18M deal to snap up Novavax facilities (Endpoints) (Fierce)
• Aclaris hammered as hair loss drug flops in PhII, days after FDA took issue with Eskata ads (Endpoints)
• Not Dead Yet – Far from It: OTC Monograph Reform Back on Congress’ Radar (FDA Law Blog)

• Xeris Pharmaceuticals Doses First Patient in Phase 2 Trial Evaluating Its Developmental Ready-to-use Glucagon in Patients at Risk From Hypoglycemia Following Bariatric Surgery (Press)
• Catabasis Pharmaceuticals Provides Update on Global Phase 3 PolarisDMD Trial for Edasalonexent at Parent Project Muscular Dystrophy 25th Annual Conference (Press)
• Advaxis Announces Increasing Focus on Neoantigen-Directed Immunotherapies and Closing of Its Phase 3 AIM2CERV Study (Press)
• Oxthera Presents Continuous Strong Data from an Interim Analysis of Its Phase 2 Study With Oxabact in Primary Hyperoxaluria (Press)
• LifeMax Receives Orphan Drug Designation From the United States Food & Drug Administration For LM-030 For The Treatment of Netherton Syndrome (Press)
• Arrowhead Pharmaceuticals Receives Fast Track Designation for ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
• Aridis Pharmaceuticals Receives Orphan Drug Designation for AR-501 (Press)

• Medtronic Completes Acquisition of Titan Spine (Press)
• CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers (Focus)
• Philips issues another external defibrillator warning (MassDevice)
• FDA wants tighter control of certain prostate ablation devices (MassDevice)
• Benvenue Medical Receives FDA Clearance for Luna XD Minimally Invasive Expandable Interbody Device (Press)
• Dignitana receives FDA clearance for DigniCap Delta scalp cooling system (Press)
• Scanning UDI Bar Codes Helps VA Hospital Gain New Efficiencies (MDDI)
• Class 1 Device Recall enFlow IV Fluid Warmer (FDA)
• Class 1 Device Recall enFlow Disposable Cartridge with IV Extension Set (FDA)
• Class 1 Device Recall SmartSite Syringe Administration Set (FDA)

• US states unsure how to halt online sales of abortion pills amid clinic crackdown (Reuters)
• AbbVie deal for Allergan not about the taxes thanks to 2017 law (BioPharmaDive)
• PhRMA responds to Florida’s request for information on drug importation (PhRMA)
• Medicare CAR-T Coverage Decision Appears Hung Up In Political Review, Former CMS Official Says (Pink Sheet-$)
• USMCA Trade Negotiations: Could US House Dems' Talks Open Door For AAM Changes? (Pink Sheet-$)
• McKesson Dodges Generic Drug Price-Fix MDL For Now (Law360-$)
• Biotech Prospects for Patent Reform (Patent Docs)
• Common Sense Cert Petition On CAFA (Drug & Device Law)
• 2nd Of 5 NY Docs Eyed For Taking Insys Kickbacks Cops Plea (Law360-$)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’ (Focus)
• What is understood by 'deletion of a non-significant parameter'? (MHRA)
• EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients (Pink Sheet-$)
• Patients to check if they have prescription-only medicines being recalled (MHRA)
• FMD Alert: Class 2 (MDR 123-05/19) (MHRA)

• India’s Piramal adds capacity to U.S. high-potency API site (Fierce)
• Lapses In Drug Quality - Marketers Will Also Be Accountable In India (Pink Sheet-$)
• New cholera vaccine in clinical stage promises to end supply shortage (Economic Times)

• GMP clearance guidance update (version 18.3) (TGA)

• Joint Price Negotiations Move Ahead In Latin America (Pink Sheet-$)

• Sperm Donors Can’t Stay Secret Anymore. Here’s What That Means. (NYTimes)