Regulatory Focus™ > News Articles > Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin; GSK CEO Walmsley Says Pharm

Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin GSK CEO Walmsley Says Pharma is Top Priority (26 April 2017)

Posted 26 April 2017 | By Michael Mezher 

Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin GSK CEO Walmsley Says Pharma is Top Priority (26 April 2017)

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

In Focus: US

  • US FDA Still Waiting For Cures Money, Woodcock Says (Pink Sheet-$)
  • The CEO of HIV (NYTimes)
  • Four Decades Of Hacking Biotech And Yet Biology Still Consumes Everything (LifeSciVC)
  • FDA GMP Warning Letters Review: Rate Soared In 2016 On Sterility And Data Integrity Concerns (Pink Sheet-$)
  • High-Stakes Meeting Between Avexis and FDA Will Set the Course for Gene Therapy and Dying Kids (The Street)
  • Generic Drug Industry Group Seeks FDA Regulation Changes (Focus)
  • FDA Warns 14 Companies for Selling Fake Cancer Treatments (Focus)
  • Court Applies First Amendment Protections to FDA-Related Claims (FDA Law Blog)
  • AstraZeneca third-line lung cancer trial delayed by few months (Reuters)
  • Novartis to speed up bid for MS drug approval, changes target (Reuters)
  • Biogen profit beats on surprisingly strong Spinraza sales (Reuters)
  • Is Amgen losing confidence in Novartis-partnered migraine program? (Fierce)

Sponsored Content: Trying to Map Out the Transition to Comply with IDMP Standards?

In Focus: International

  • Glaxo's New CEO Walmsley Pledges to Make Drugs the Priority (Bloomberg)
  • India's antitrust watchdog orders probe into Roche cancer drug (Reuters) (Economic Times)
  • Brexit leaves industrial firms staring into regulatory void (Reuters)
  • NICE green light for Lilly's psoriasis drug (PharmaTimes) (PharmaLetter-$)
  • Japan's Otsuka aims to apply for TB drug approval in India in 90 days (Reuters)
  • Novartis sets sights on return to growth in 2018 (Reuters)
  • Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (Focus)
  • AstraZeneca moving costs rise as new HQ nears completion (Reuters)
  • Shire finally bags EU approval for rare disease drug Natpar (PMLive) (Press)
  • Akebia Expands Anemia Pill Partnership to Include Europe, China Rights (The Street) (BioCentury)
  • UniQure's haemophilia B therapy picks up PRIME status (PharmaTimes)
  • EU issues full approval for AZ' Tagrisso (PharmaTimes)
  • Biogen's Spinraza Needs Long-Term Confirmatory Data, Says EMA (SCRIP-$)
  • UK Election Extends Industry Wait For Accelerated Access Review Response (Pink Sheet-$)
  • How China Is On Course To Unseat US As The Next Leader In Global Heath (Forbes)
  • Taiwan eyes UN health meet, risks setback in China ties (Reuters)

US: Pharmaceuticals & Biotechnology

  • The Real Risk in Life Sciences (BioSpectrum)
  • Discounts Will Be Key Factor In US Uptake Of Samsung's Renflexis (SCRIP-$)
  • Pfizer, Genentech Warn Against Requiring 'Impractical' Switching Studies for Biosimilar Interchangeability (FDANews-$)
  • Biogen Staying "Laser-Focused" On Neuroscience (SCRIP-$)
  • Pharma Firms Spend 'Billions' On Failing: More Collaboration Needed On Innovation (Pink Sheet-$)
  • FDA Says Adios to Paper Filing (PharmaceuticalManufacturing)
  • Interneuron Strategy Could Lead To Cell Therapy For Sci (BioCentury)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Alnylam Reports Final 24-Month Results from Phase 2 Open-Label Extension Study of Patisiran, an Investigational RNAi Therapeutic in Development for the Treatment of Hereditary ATTR (hATTR) Amyloidosis (Press)
  • The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran (Press)
  • FDA Clears Flex Pharma's FLX-787 to Commence US Phase 2 Trial in ALS Under IND (Press)
  • New data at AAN reinforce clinical benefit of Roche's OCREVUS™ (ocrelizumab) for relapsing and primary progressive multiple sclerosis (Press)

US: Medical Devices

  • A Look at Current Technology to Prevent and Detect Sepsis (MDDI)
  • Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use' (MDDI)
  • Neural Interface Research Moves Forward, Inside and Outside Silicon Valley (MDDI)
  • Allergan wins FDA nod for TrueTear tear-inducing neurostim (MassDevice)
  • Baxter Reports First-Quarter 2017 Results and Increases Financial Outlook for Full-Year 2017 (Press)
  • How medtech companies can benefit from agile marketing (MedicalDesign&Outsourcing)
  • Class 1 Device Recall Heartware Ventricular Assist System (FDA)
  • Bausch + Lomb Receives 510(k) Clearance From FDA For Vitesse Hypersonic, Open-Port Vitrectomy System (Press)
  • LimFlow Receives FDA Approval for U.S. Feasibility Study of Minimally-Invasive Technology Designed to Restore Perfusion in "No Option" Critical Limb Ischemia Patients (Press)
  • ALung submits FDA IDE app for HemoLung device (MassDevice)
  • Ivantis launches 2nd IDE study of Hydrus microstent (MassDevice)
  • Five-Year Data from the Medtronic ENGAGE Registry Demonstrate Durable, Consistent, and Proven Outcomes in Real-World Setting (Press)

US: Assorted & Government

  • GSK Trial Shows Jury's New Role In Drug Labeling Cases (Law360-$)
  • Pre-Obamacare, Preexisting Conditions Long Vexed States And Insurers (KHN)
  • SCOTUS Hears Arguments Over the Jurisdiction for BMS' Plavix Cases (FDANews-$)
  • Merck Settles Keytruda Patent Suit For $19.5M (Law360-$)
  • The MacArthur Amendment Language, Race In The Federal Exchange, And Risk Adjustment Coefficients (HealthAffairsBlog)

Upcoming Meetings & Events

Europe

  • Falsified Medicines Directive: opportunity or obstacle? (Pharmaceutical Journal)
  • Circassia defends allergy flops as business reboot continues (Fierce)
  • A Strong EU IP Framework Guarantees Future Innovation For Patients (EFPIA)
  • LabCorp to relocate and expand UK CMC business (InPharmaTechnologist)
  • Bioness wins CE Mark for L300 Go FES system (MassDevice)

Asia

  • Why China Is Selling Cheap HIV Tests In Campus Vending Machines (NPR)

India

  • Medtronic to provide consistent access of latest drug eluting stents following govt directive (PharmaBiz)
  • WHO-GMP unit complies with deficiencies stated in notice by state FDA as part of probe in narcotics drug case (PharmaBiz)
  • Move to make prescription of generics mandatory may kill Indian pharma industry, 9,500 units will close down: J Jayaseelan (PharmaBiz)

Canada

  • Health Canada to go eCTD-only for Drug Applications (Focus)
  • Rivanna wins Health Canada nod for Accuro spinal navigation system(MassDevice)

General Health & Other Interesting Articles

  • Scientists develop fluid-filled artificial womb to help premature babies (Reuters) (MIT Technology Review)
  • Pregnant women need routine blood pressure checks (Reuters)
  • Ok to wait for colonoscopy after positive fecal test results (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.


Categories: Recon, Regulatory News

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