Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Medicines Co's UTI Antibiotic; Nonprofit Gets PRV for First FDA Appro

Regulatory Recon: FDA Approves Medicines Co's UTI Antibiotic Nonprofit Gets PRV for First FDA Approved Chagas Treatment (30 August 2017)

Posted 30 August 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Medicines Co's UTI Antibiotic Nonprofit Gets PRV for First FDA Approved Chagas Treatment (30 August 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA approves Medicines Co's urinary tract infection drug (Reuters) (Endpoints) (Press) (FDA)
  • A nonprofit group's Chagas drug beat out Martin Shkreli's old rival to FDA OK, valuable PRV (Endpoints) (Medpage) (FDA)
  • New Drug Price Questions Loom After Gilead's Cancer Purchase (Bloomberg) (Washington Post)
  • What's Next On Gilead's Shopping List (SCRIP-$)
  • Which TV shows get blanketed by pharma ads — and which don't? You'd be surprised (STAT)
  • In stunning about-face, FDA invites Eli Lilly to quickly refile blockbuster hopeful baricitinib (Endpoints) (Press)
  • ImmunoGen strikes deal on cancer drug technology with Jazz Pharmaceuticals (STAT) (Fierce)
  • Abbott releases new round of cyber updates for St. Jude pacemakers (Reuters) (FDA)
  • Have FDA Studies Changed Rx Drug Advertising? (Pink Sheet-$)
  • Gutierrez Leaving FDA After Leading Dx Regulatory Efforts During Precision Medicine Revolution (GenomeWeb)
  • FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug (Focus)
  • Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database (Focus)

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In Focus: International

  • UK report plans boost for life sciences as Brexit looms (Reuters) (Bloomberg) (PharmaTimes) (Pharmafile) (ABPI) (GOV.UK) (Report)
  • MHRA Offers Interactive Guide on New EU Device, IVD Regulations (Focus)
  • Open borders key to Swiss pharma's EU success (Financial Times)
  • Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (Focus)
  • EVP of Diabetes decamps from Sanofi to become Almirall CEO (Pharmafile) (Fierce)
  • Meyer leaves troubled uniQure for R&D post at Therachon (Fierce)
  • Report: Chinese medical device market growing faster than pharma (MassDevice)
  • US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP (Emergo)
  • Interpol led operation seized 420 tonnes of fake meds in West Africa (InPharmaTechnologist)
  • Aurobindo Pharma in talks to buy Shreya Life Sciences's Russia business (LiveMint)
  • How is India's draft pharma policy revamping drug price regulation? (Business Standard)
  • Indian Gov outlines plan to favour drugs containing locally made APIs (InPharmaTechnologist)

Pharmaceuticals & Biotechnology

  • Otonomy staggered by an ugly PhIII failure for lead pipeline drug (Endpoints) (Reuters)
  • Allergan hits its already battered Irvine site with another round of job cuts (Fierce)
  • FDA Warns Indian Contract Manufacturer Hetero Labs (Focus)
  • Which PBM Best Managed Drug Spending in 2016: CVS Health, Express Scripts, MedImpact, or Prime? (rerun) (Drug Channels)
  • Allergan heads to federal court to defend Restasis against early generic rivals (Fierce)
  • Drug Co-Packaging Proposed Rule Could Hamper Some OTC Marketing (Pink Sheet-$)
  • When Science Is Not Enough: Pharma Needs Organizational Change (SCRIP-$)
  • Immunotherapy firm develops breakthrough method for robust bispecific antibody production (Pharmafile)
  • What to look for tonight when Incyte, Merck disclose new skin cancer immunotherapy study results (STAT)
  • BioMarin says the FDA game clock now ticking on their blockbuster hopeful pegvaliase (Endpoints)
  • Shire tweaks popular hemophilia app platform to serve hard-to-treat patients (Fierce)
  • Why Marijuana Compounds Could Eventually Replace Anti-Anxiety Meds (Forbes)
  • Selling Pet Pills to People? PetMed Express' Publicity Crisis (Forbes)
  • Catalent: FY17 expectations exceeded, biologics strategy making strides (Outsourcing Pharma)
  • Five Prime cuts loose from InhibRx immuno-oncology deal (Fierce)
  • Cancer patients lack access to fertility support (Reuters)
  • Star team quietly raises $21M to launch the latest immuno-oncology startup Torque (Endpoints)
  • How Moldy Hay And Sick Cows Led To A Lifesaving Drug (NPR)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Prometic Gains On Rare Pediatric Disease Designation (BioCentury)
  • Eisai publishes positive overall survival data from Lenvima study (PharmaLetter-$)
  • GeNeuro, Servier 'Disappointed' With Mid-Way Phase IIb Multiple Sclerosis Study (SCRIP-$)
  • Breakthrough therapy designation granted to Daiichi's DS-8201 (PharmaLetter-$)

Medical Devices

  • Avoid the Consequences of an Experiment Gone Wrong (MDDI)
  • Smiths Medical Receives FDA 510(k) Clearance on Wireless Ambulatory Infusion Pump (Press)
  • FDA Grants ExThera Medical's Seraph® 100 Blood Filter Expedited Access Pathway (EAP) Designation (Press)
  • Medizone to pursue de novo pathway for AsepticSure disinfection system (MassDevice)

US: Assorted & Government

  • Evaluating the impact of Affordable Care Act repeal on America's opioid epidemic (PLOS)
  • Where did all the bare counties go? Four takeaways from Nevada's fight to preserve coverage (STAT)
  • CMS Details 2018 Open Enrollment Period Procedures; Tax Court Rules APTC Must Be Repaid After Income Change (Health Affairs Blog)
  • What Medicaid Recipients And Other Low-Income Adults Think About Medicaid Work Requirements (Health Affairs Blog)
  • Amgen, Sandoz Battle Over High Court's Biosimilar Ruling (Law360-$)
  • Dr. Reddy's Hid Manufacturing Woes, Investors Say (Law360-$)
  • DC Circ. Backs FDA's Approval Of Abilify Maintena Rival (Law360-$)

Upcoming Meetings & Events



  • Repatha Receives Approval for New 420mg Single-Dose Delivery Option in Japan (Astellas)


  • India's biogenerics industry poised to exploit opportunities (PharmaLetter-$)
  • Maha FDA cancels 607 licenses, suspends 2,620 licenses of pharmacy outlets for non-compliance of norms (PharmaBiz)
  • It's time industry and govt team-up to list down top 10 most critical APIs to focus on time-bound production: KPDMA (PharmaBiz)
  • Experts in pharma education stress on the need to update syllabus of pharmacy education in every two-three years (PharmaBiz)


  • Hazard alert - labelling update relating to potential risks (TGA)
  • Seasonal influenza vaccines - quality module (TGA)
  • TGA presentations: 2017 ARCS Annual Conference, 22-24 August 2017 (TGA)

Other International

  • WHO and partners supporting health authorities rapidly respond to Cholera outbreak in North-Eastern Nigeria (WHO)

General Health & Other Interesting Articles

  • Religious young women less educated about HPV vaccine (Reuters)
  • Helping Patients Make More Informed Postacute Care Choices (Health Affairs Blog)
  • Improving Older Adults' Health: Creating Solutions With—Not For—Them (Health Affairs Blog)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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