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Regulatory Focus™ > News Articles > 2019 > 9 > Recon: FDA Approves Aspen’s Drug to Prevent Preterm Birth; At Least 20 States Reject Purdue Settleme

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

Posted 12 September 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • Neurotechnology holds the key to a healthy ageing population in 2050 (Financial Times)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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