Regulatory Recon: FDA Panel Finds PTC's Duchenne Data Inconclusive; Lilly Gets US Approval for Breast Cancer Drug Verzenio (29 September 2017)

Posted 29 September 2017 By Michael Mezher

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

In Focus: US

  • FDA panel votes no on PTC's Duchenne muscular dystrophy drug (STAT) (Endpoints) (Reuters) (Fierce)
  • Eli Lilly wins US approval for breast cancer drug Verzenio (Reuters) (Pharmafile) (FDA)
  • Abbott wins US antitrust approval to buy Alere with conditions (Reuters) (FTC)
  • Merck to stop development of hepatitis C treatments (Reuters) (PharmaTimes) (Endpoints)
  • Eli Lilly R&D chief Jan Lundberg heads for the exit as CEO assembles a new team at the top (Endpoints) (Press)
  • Big Pharma Doesn't Want Health Outcomes To Sway Pricing -- At Least Not Yet (Forbes)
  • Zogenix stock soars after epilepsy test success (Reuters) (Endpoints)
  • RNA biotech Arcturus backs onto Nasdaq in Alcobra deal (Fierce)
  • Gottlieb: Immediate Release Opioids to be Subject to REMS (Focus) (FDAVoice)
  • FDA Finalizes Guidance on Emerging Manufacturing Tech Program (Focus)
  • Washington state sues OxyContin maker Purdue Pharma (Reuters)
  • Demanding action from Trump on MS drug prices, Elijah Cummings takes to Twitter (STAT)
  • FDA commissioner Gottlieb's travel preferences? Commercial jets, a la mode (Endpoints)

In Focus: International

  • Improving collaboration to protect public health – MHRA and Care Quality Commission sign MoU (MHRA)
  • Brazilian Regulators Shaking Up BGMP Certification Process for Higher-risk Devices (Emergo)
  • The Zika Virus Grew Deadlier With a Small Mutation, Study Suggests (NYTimes)
  • Exploring opportunities for collaboration between regulators and healthcare payers (EMA)
  • MHLW Unveils Planned Framework for Conditional Early Approval Scheme (Pharma Japan)
  • European Regulatory Roundup: EMA Overrode Pharma Concerns in Adopting First-in-Human Guideline (Focus)
  • WHO tells governments to reject Philip Morris-funded smoking foundation (Reuters) (WHO)
  • Why would Novartis buy a $2.6B radiotherapy maker? Its neuroendocrine franchise, analyst says (Fierce)
  • Almirall ends research for two products in US, EU Trials to Continue (Reuters)
  • WHO recommends large-scale deworming to improve children's health and nutrition (WHO)
  • Trial data suggest new typhoid shot could halve infection rate (Reuters) (NYTimes)

Pharmaceuticals & Biotechnology

  • Humira Biosimilar Update: Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins (Patent Docs)
  • Off-Label Marketing Case Tossed (Drug & Device Law)
  • Many kids dying of cancer get intense care at end of life (Reuters)
  • Child brain cancer treatments can be personalised: study (PharmaTimes)
  • Here Is What Vivek Ramaswamy Wrote To His Employees After Axovant's Drug Failed (Forbes)
  • As Vertex works through CF combos, it's looking to Gilead's example: executive (Fierce)
  • Pharmaceutical Manufacturing in Puerto Rico after Maria– Where does it go from here? (FDA Law Blog)
  • Upcoming events – FDA's date for Mylan's Neulasta copy and Rhopressa's panel (EP Vantage)
  • Interview – Shire needs to shore up to stem haemophilia bleeding (EP Vantage)
  • FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings (Pink Sheet-$)
  • Chris Carpenter joins the R&D exodus out of pharma; George Church's eGenesis selects Jodie Morrison as new CEO (Endpoints)
  • The $913M bonanza: Arie Belldegrun and his top team at Kite show you how to make a really rich deal (Endpoints)
  • Cancer, gene therapy biotechs raise $303M in IPO bonanza (Fierce)
  • Breakthrough Pain Treatment Or Snake Oil? You Decide. (NPR)
  • Thiel backs Peptilogics to move antibiotic toward IND (Fierce)
  • Prothena carefully explains why it's killing a psoriasis drug after PhIb (Endpoints)
  • FDA Says MedWatccher App is Down, Directs Reporters to Website (FDA)
  • Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations; Draft Guidance for Industry; Availability (FDA)
  • Genetically modified approaches to fighting malaria succeed in new tests (Washington Post) (NIH)
  • Psoriasis patients face increased risk of heart attacks and death (Reuters)
  • Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1 (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Roche's Perjeta regimen gets FDA priority review in breast cancer (Reuters) (Press)
  • bluebird bio Announces First Patient Treated with Second Anti-BCMA CAR T bb21217 in CRB-402 Phase 1 Study in Patients with Relapsed/Refractory Multiple Myeloma (Press)
  • National Cancer Institute Awards Grant to NuvOx Pharma for Phase II Clinical Trial in Brain Cancer (Press)
  • Chi-Med to Present Savolitinib and Fruquintinib Clinical Data at WCLC 2017 Annual Meeting (Press)
  • Syros to Present Biomarker Data from Ongoing Phase 2 Clinical Trial of SY-1425 at ESH Conference on AML (Press)

Medical Devices

  • Guidance: Classification and Requirements for Laser Illuminated Projectors (FDA)
  • Guidance: Display Devices for Diagnostic Radiology (FDA)
  • Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (FDA)
  • Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation (FDA)
  • As Consumer DNA Testing Grows, Two States Resist (MIT Technology Review)
  • FDA warns on endoleaks with stent grafts (MassDevice) (FDA)
  • Sustainable Pacemaker Research Accelerates (MDDI)
  • Insulet "bets big" on Massachusetts with new manufacturing facility in Acton (Drug Delivery)
  • Hologic wins expanded FDA nod for Cynosure SculpSure (MassDevice)
  • SteadyMed requests meeting with FDA over rejected application for drug-device combo (MassDevice)
  • Medtrobotics submits FDA application for transabdominal robotic scope (MassDevice)

US: Assorted & Government

  • Hawaii, Washington Did Not Bill Manufacturers for Some Rebates for Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations (HHS OIG: Hawaii, Washington)
  • Senators close to bipartisan deal on health exchanges: Schumer (Reuters)
  • Health Secretary Price believes has president's confidence (Reuters)
  • FTC Sending Refund Checks Totaling More Than $210,000 to Consumers Who Bought Elimidrol 'Opiate Withdrawal' Product (FTC)
  • J&J Loses Bid For Rehearing Of FCA Ruling By 1st Circ. (Law360-$)
  • Valeant Used 'Clandestine Network' To Cook Books, Says Suit (Law360-$)

Upcoming Meetings & Events

Europe

  • Fimea to conduct a survey on the Finns' opinions about medicines (FIMEA)
  • Marketing authorisations granted in August 2017 (MHRA)
  • Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group (EMA)
  • ABPI welcomes the appointment of the non-executive Board members of UK Research and Innovation (ABPI)

India

  • Government blocks companies from withdrawing stents until December 2017 (Economic Times)
  • India's NPPA tells Boston Scientific to choose between exiting stent market or seeking higher price caps (MassDevice)
  • Gujarat leads in pharma exports with highest number of 280 WHO-GMP certified manufacturing units followed by Maharashtra (PharmaBiz)

Australia

  • Lucrin Depot Paediatric 30 mg PDS (leuprorelin acetate) (TGA)

Canada

  • Consultation: proposals for prescription drug transparency (Health Canada)
  • Health Product InfoWatch – September 2017 (Health Canada)

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 news@raps.org.

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

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