Recon: FDA Approves Aspen’s Drug to Prevent Preterm Birth; At Least 20 States Reject Purdue Settlement

• At least 20 states reject settlement with OxyContin maker Purdue Pharma (NBC) (AP)
• Purdue OxyContin settlement would rank among largest in pharma history (Reuters)
• US judge approves novel framework for opioid settlement talks (Reuters)
• Carcinogens Have Infiltrated the Generic Drug Supply in the US (Bloomberg)
• Aspen's drug to prevent preterm birth approved by FDA (Reuters)
• Congress Rakes In Millions From Drugmakers (KHN)
• With some safety caveats, new Moderna data show mRNA can teach the body to make its own medicine (STAT) (Endpoints) (Fierce) (BioPharmaDive) (Press 1, 2)
• GE’s health unit wins first FDA clearance for A.I.-powered X-ray system (CNBC) (MassDevice) (Press)
• Tocagen's brain cancer treatment fails late-stage study, shares crash (Reuters) (Endpoints) (Press)

• A Snapshot of Prescription Drug Use in Britain Sparks a Call for Alternatives (NYTimes)
• Vertex strikes a deal with Scotland for its cystic fibrosis medicines, but will England be next? (STAT) (PharmaTimes) (BioPharmaDive) (Press)
• Cancer drugs among US goods spared from tariffs as China issues first exemptions in trade war (Endpoints)
• Israel's Healthy.io raises $60 million, gets FDA ok for urine test (Reuters)
• Roche's satralizumab cuts relapse risk in rare disease phase 3 (Fierce) (PMLive) (Endpoints) (Press)
• Vaccination: European Commission and World Health Organization join forces to promote the benefits of vaccines (WHO)
• Firms Still In Dark Over No-Deal Brexit Supply Routes (Pink Sheet-$)
• NICE approves BioMarin’s Brineura after initial setback (PMLive)

• Opinion: Big Pharma is abusing patents, and it's hurting Americans (CNN)
• In US Biosimilars Run Into More Roadblocks (Forbes)
• FDA rebukes Sprout over a statement claiming warning on its female libido pill was removed (STAT)
• CRISPR Gene-Editing May Offer Path To Cure For HIV, First Published Report Shows (NPR) (NYTimes)
• This Treatment Can Cure Cancer. Can It Mend the Heart? (NYTimes)
• Cancer researchers’ failure to disclose industry payments damages patient trust — and care (STAT)
• Mavenclad real-world data shows sustained efficacy (PharmaTimes)
• US FDA's New Drug Assessors More Experienced With Rare Disease Issues (Pink Sheet-$)
• Generic Drug Assessment Times Show Improvement In GDUFA Performance Report (Pink Sheet-$)
• Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey (Pink Sheet-$)
• Bristol-Myers Squibb Board Announces Election of Three New Directors (Press)
• Roche vet Jean-Jacques Garaud woos international believers in his French startup's take on septic shock (Endpoints)
• Bayer trims 2 top execs, shrinks management board; SpringWorks boosts size of IPO (Endpoints)
• Ipca Labs plant blasted by FDA for a 'cascade of failure' (Fierce)

• J&J’s ponesimiod tops Aubagio in head-to-head MS trial (PMLive) (Endpoints)
• Roche's Tecentriq excels in another lung cancer study (Endpoints) (Press)
• Strekin AG Announces Completion of Patient Recruitment in the RESTORE Phase 3 Clinical Study of STR001 (Press)
• Concert Pharmaceuticals Announces CTP-543 Phase 2 Alopecia Areata Data Selected for Late-Breaker Oral Presentation at 2019 EADV Congress (Press)
• Navitor’s Three Phase 1 Studies for NV-5138 Show Antidepressant Effects and Biomarker Impact, Supporting Further Development of Direct Activator of mTORC1 in Depression (Press)
• X4 Pharmaceuticals to Present Phase 2a Data for Mavorixafor in Combination with Axitinib at European Society for Medical Oncology (ESMO) 2019 Congress (Press)
• NOXXON Initiates Patient Recruitment for Phase 1/2 Clinical Trial Combining NOX-A12 & Radiotherapy for the Treatment of Brain Cancer Patients (Press)
• GT Biopharma Announces FDA Notification of Commencement of Enrollment in Human GTB-3550 Trike™ Phase i/ii Clinical Trial (Press)
• Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Clinical Trial to Leverage Novel Digital Endpoints (Press)

• Applied BioCode Submits Respiratory Pathogen Panel to FDA (GenomeWeb)
• V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension (Press)
• Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device (Press)
• HeartFlow Announces FDA Clearance for HeartFlow Planner (Press)

• The shine is off Juul (Politico)
• DEA Proposes to Reduce the Amount of Five Opioids Manufactured in 2020, Marijuana Quota for Research Increases by Almost a Third (DoJ)
• FDA’s Warning Letter to Juul & the First Amendment (Harvard Bill of Health)
• California voters could get a chance to overturn new vaccine law (SacBee)
• 2020 Election: How The Democrats Say They'd Lower Drug Prices (Forbes)
• Florida Businessman Faces Sentencing in $1B Medicare Fraud (NYTimes)
• Appeals court tosses two ConforMIS patents despite settlement with Smith & Nephew (MassDevice)
• Court Tosses Cookie Cutter Allegations (Drug & Device Law)
• CRISPR Interference: Motion Practice (Patent Docs)

• FDA Advisory Committee Calendar
• Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting – 14 November 2019
• Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting – 7 October 2019

• EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work (Focus)
• Open letter to the Members of the European Parliament on the importance to sustain EU progress in fighting against antimicrobial resistance (AMR) (EFPIA)
• Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution EL (19)A/21 (MHRA)

• Atomwise inks China deal as list of AI collaborations lengthens (Endpoints)

• Strides Pharma buys 70% in Swiss company (Economic Times)
• Pharma City and Medical Device Park gives much needed push to industrial growth in Telangana (Pharmabiz)
• DoP rejects Cipla’s review petition against fixing ceiling prices of emtricitabine+ tenofovir alafenamide tablets (Pharmabiz)
• Medical devices exporter Poly Medicure eyes 17-18% revenue growth in FY19-20 (Pharmabiz)

• The fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended (TGA)
• Interim decisions and invitation for further comment on substances referred to the June 2019 ACMS/ACCS meetings (TGA)
• Consultation: Products used for and by people with disabilities (TGA)

• Neurotechnology holds the key to a healthy ageing population in 2050 (Financial Times)