Regulatory Focus™ > News Articles > Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offse

Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017)

Posted 13 December 2017 | By Michael Mezher 

Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017)

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

In Focus: US

  • Why a drug for aging would challenge Washington (Politico)
  • FDA statement on The Uncertain Hour's OxyContin episode (Marketplace)
  • How Alex Azar could try to shake up drug prices through Medicare Part B (STAT)
  • Some drug makers are considered good corporate citizens (STAT              )
  • What pharma's watching as Congress tries to hammer out a tax bill (STAT)
  • President Signs NDAA Conference Report, Bill to Ensure FDA's Authority Remains in Place (House E&C)
  • Merck says it has restored most of its manufacturing hit by cyberattack (Fierce)
  • Chemotherapy-Free Cancer Treatments Move Closer To Reality (Forbes)
  • Portfolio Scorecard: Atlas' Biotech Seed Class of 2013 (LifeSciVC)
  • Collins, Alexander say White House backs ACA stabilization this year (Politico)
  • Vertex Pharmaceuticals Could Be Bought Out for $205 in 2018: Deutsche Bank (The Street)
  • This Startup Has a New CRISPR Enzyme - And Says It Will Give It Away For Free (Forbes)
  • Lilly forecasts 2018 profit and revenue largely above estimates (CNBC) (Press)]
  • Bringing Early Feasibility Studies for Medical Devices Back to the United States (FDAVoice)

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In Focus: International

  • Israel's Teva to cut jobs in restructuring on Thursday: report (Reuters) (Endpoints)
  • Teva turnover continues with resignation of former chairman, interim chief (Fierce)
  • France's Sanofi pins hopes on new drugs after setbacks (Reuters) (Endpoints)
  • Pharma companies fall foul of ABPI's Code of Practice (PharmaTimes)
  • Did Sanofi, WHO ignore warning signals on dengue vaccine? (Reuters)
  • Dengue vaccine: Ex-PFDA chief defends circular removing post-marketing surveillance (Rappler)
  • Philippines' Duterte says dengue campaign carried out in 'good faith' (Reuters) (Rappler)
  • Daiichi ditches Nektar following cancer drug flop (Endpoints)
  • MSF wins Sovaldi battle in Ukraine as Gilead relents (PharmaLetter-$)
  • Korea 2017 Review: Biosimilar Advances, R&D Progress Restore Confidence (SCRIP-$)
  • Why British businesses are calling to stay under EU rules (Financial Times)
  • Pharma warning of Brexit impact to public-health emergencies (Financial Times) (InPharma)
  • EMA approves production at Samsung Biologics 152,000L plant (BioPharmaReporter)
  • Bayer's Stivarga Approved in China as Second Line Treatment for Liver Cancer (The Financial)
  • Aurora Cannabis wins rights for licensing talks with CannaRoyalty (Reuters)

Pharmaceuticals & Biotechnology

  • Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs (Blood)
  • Ash 2017 – Transcend fails to prevent Juno's second collapse (EP Vantage)
  • FDA Plans Meeting On 'Unprecedented' Steps To Combat Opioid Crisis, Including Nationwide PDMP (IHP-$)
  • Results of FDA study supports development of high throughput sequencing for viral safety evaluation of biologic materials (FDA)
  • FDA to study deputizing consumers to find bad ads, as warnings to pharma plunge (STAT)
  • Gene Therapy Advances, But Hemophilia Is No Easy Target (Xconomy)
  • GlaxoSmithKline, now vying with AstraZeneca, scores brand-new market for Nucala (Fierce)
  • Immuno-Oncology Drug Development -- Too Much Of A Good Thing? (Forbes)
  • Blood cancer patients over 75 are significantly underrepresented in clinical trials, study finds (Pharmafile)
  • Novel Technique Opens Door to Super Resolution of Single Molecules in Cells (GEN)
  • How Biocon Site Prevented FDA 'OAI' Finding From Derailing Biosimilars (Pink Sheet-$)
  • Janssen Oncology rolls out Cancer.com, a website that's been years in the making (Fierce)
  • Kite talks audits, training and dry runs across CAR T supply chain (BioPharmaReporter)
  • Boehringer Ingelheim: Pharma cannot overcome social issues, fear, and mistrust alone (Outsourcing Pharma)
  • Vernalis, Daiichi form oncology drug discovery collaboration (Fierce)
  • Phrma Launches Opioid Initiative (BioCentury) (Pink Sheet-$)
  • Mundipharma names new President and CEO (Pharmafile)
  • NEA leads a big syndicate on $100M mega-round for Allakos (Endpoints)
  • Serum Institute eyes pharma's big-selling vaccines as CEO touts growth ambitions (Fierce)
  • Yervoy inventor's oncology startup Pionyr gets $62M for tumor-fighting tech (Endpoints)
  • PsiOxus banks first milestone for BMS-backed cancer therapy (Fierce)
  • Aduro Discontinues Development Of CRS-207 (BioCentury)
  • Provectus CEO siphoned $3M for "surgeries, restaurant tips and travel" (Fierce)
  • Many young U.S. men at high risk for HIV do not take anti-HIV pill (Reuters)
  • Antiretroviral therapy and population mortality: Leveraging routine national data to advance policy (PLOS)
  • DHL receives pharma certifications at 7 US-based air freight stations (OutsourcingPharma)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Regeneron, Sanofi are ready to debut the 6th PD-1/L1. Is it still possible to stand out from the growing crowd? (Endpoints)
  • NeuroVive's KL1333 Program Granted Orphan Drug Designation by the European Commission (Press)
  • Food And Drug Administration Extends Action Date For XELJANZ® (Tofacitinib) Supplemental New Drug Application In Ulcerative Colitis By Three Months (Press)
  • Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism (NEJM)

Medical Devices

  • CardioBrief: In Defense Of ORBITA (Medpage)
  • FDA suggests controls on interoperable devices (MassDevice)
  • US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018 (Emergo)
  • Class 1 Device Recall LIFEPAK(R) defibrillation electrodes (FDA 1, 2)
  • Helping Patients Be Compliant with Medical Device Use (MDDI)
  • Boston Scientific wins FDA nod for Vercise DBS for treating Parkinson's disease (MassDevice)
  • Senzime wins CE Mark for TetraGraph neuromoscular monitor (MassDevice)
  • Medtronic wins CE Mark for Endurant stent graft, HeliFX EndoAnchor combo (MassDevice)
  • Stryker completes tender offer for French spinal implant maker Vexim (MassDevice)
  • Think Surgical wins CE Mark for TKA procedures with TSolution One robotic platform (Robot Report)

US: Assorted & Government

  • Nevada Cardiologist Arrested For Unlawful Distribution of Prescription Opioids And Health Care Fraud (DOJ)
  • 21st Century Oncology to Pay $26 Million to Settle False Claims Act Allegations (DoJ)
  • Insider trading case against Ackman, Valeant approaches trial: report (Fierce)
  • SEC charges Provectus founding CEO Dees with looting millions for girlfriends' cosmetic surgeries, travel and more (Endpoints)
  • Celebrating 21st Century Cures One Year Later (BIO)
  • Whistleblower Says Drugmaker Fired Him for Raising Concerns About CMO (FDANews-$)
  • Amgen Whistleblower Was Original Source, 2nd Circ. Told (Law360-$)
  • Fed. Circ. Affirms PTAB Ax Of Daiichi's Heart Drug Patents (Law360-$)
  • Actavis Asks Calif. Justices To Revive Opioid Coverage Bid (Law360-$)
  • Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-related Substances in Schedule I (DEA)
  • EDNY Rejects Successor Liability in Hip Implant Case (Drug & Device Law)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments – 30 January 2018
  • Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop – 19 March 2018

Europe

  • Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA)

Asia

  • Fosun Gets Chinese Rights For Ardelyx's Tenapanor (BioCentury)

India

  • JB Chemicals & Pharma gets USFDA nod for hypertension tablets (Economic Times)
  • Delhi to cap profit percentage on drugs in private hospitals (Economic Times)
  • DoP directs NPPA to set aside its order on fixation of ceiling prices of erythromycin formulations (PharmaBiz)

Australia

  • Biovigilance responsibilities of sponsors of biologicals (TGA)

Other International

  • Strategic Priority on Innovation – Concept Note (ICMRA)
  • Zika virus, not vaccine or insecticide, linked to birth defects in Brazil (STAT)
  • Half of world's people can't get basic health services: WHO (Reuters)

General Health

  • Baby Born With Heart Outside Her Body Is Saved by UK Surgeons (NYTimes)
  • Older women should not take hormones to prevent chronic diseases (Reuters)

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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