Regulatory Focus™ > News Articles > Regulatory Recon: AstraZeneca Lung Cancer Drug Fails in Phase III; Novartis Execs Indicted for Bribe

Regulatory Recon: AstraZeneca Lung Cancer Drug Fails in Phase III Novartis Execs Indicted for Bribery in Korea (9 August 2016)

Posted 09 August 2016 | By Michael Mezher 

Regulatory Recon: AstraZeneca Lung Cancer Drug Fails in Phase III Novartis Execs Indicted for Bribery in Korea (9 August 2016)

Welcome to Regulatory Reconnaissance, your adaily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Ulcerative Colitis Drugs: FDA Offers Draft Guidance on Clinical Development (Focus)
  • FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements (Focus)
  • Future of drug pricing: paying for benefits not per pill (Reuters)
  • Cancer-Drug Ads vs. Cancer-Drug Reality (NYTimes)
  • Pfizer returns rights to Pfenex for Lucentis biosimilar (Fierce) (Press) (BioPharmaReporter)
  • Pharma should not be allowed a loophole for reporting financial ties to docs (STAT)
  • Device reps in the OR (Politico)
  • Beyond CRISPR: A guide to the many other ways to edit a genome (Nature)
  • N.H. Attorney General Accuses Drug Companies Of Blocking Opioid Probe (NPR)
  • Gene-Therapy Cure Has Money-Back Guarantee (MIT Technology Review)
  • Eisai: FDA confirms enough data to move Alzheimer's drug to Phase III studies (Reuters) (Press)
  • AstraZeneca drug selumetinib fails in lung cancer study (Reuters) (PharmaTimes) (Endpoints)
  • FDA Issues Form 483 for Alexion's Rhode Island Site (Focus)
  • US Senator calls for clinical trial data sharing, consortium responds (OutsourcingPharma)
  • NIH Intends to Open New Manufacturing Facility by End of October (FDA Law Blog)
  • Kite looks to hammer home advantage over Juno with quick CAR-T approval, launch (Fierce) (Press)

In Focus: International

  • Allergan Revenue Increases, Though Loss Widens (WSJ-$)
  • Novartis execs in Korea are indicted for bribing doctors (STAT)
  • Compound found to treat three parasitic tropical diseases (Reuters) (OnMedica) (Nature)
  • EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted (Focus)
  • Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections (Focus)
  • Bangladesh Court orders 34 drug firms to halt production, again (InPharmaTechnologist)
  • Letter to Colombian President Encourages Grant of Compulsory License for Imatinib (Patent Docs)
  • FDA, MHRA and WHO Guidances Shed Further Light on Data Integrity Concerns (IPQ)
  • ICH Q12 Experts Develop Four-Tier Scheme For Harmonizing Post-Approval Changes (Pink Sheet-$)
  • Valeant Posts a Loss, Says It Will Retool—Update (WSJ-$) (Financial Times)
  • GSK mum on Strimvelis pricing model (BioCentury)
  • NICE recommends Amgen's Imlygic for advanced skin cancer (Pharmafile)
  • Medical device quality management systems: transition to new standard (TGA)
  • Six new drugs win funding nod for NHS Scotland (PharmaTImes) (EPR)

US: Pharmaceuticals & Biotechnology

  • Why Industry Says Global Post-Approval Complexity Must Change (Pink Sheet-$)
  • Measuring a serial entrepreneur's success (C&EN)
  • CRO earnings report roundup (OutsourcingPharma)
  • Syncing Up Drug Refills: A Way To Get Patients To Take Their Medicine (KHN) (Health Affairs)
  • 'Fixing' blood vessel cells to diagnose blood clotting disorders (Wyss Institute)
  • Better Modeling Through PDUFA (BioCentury)
  • Editas Partners with Adverum to Develop Genome-Editing Eye Therapies (GEN)
  • ALS Therapy Development Institute on building a patient-focused platform for precision medicine (Faster Cures)
  • Adverse Effects From Counterfeit Alprazolam Tablets (JAMA)
  • Merck trims network to realise Sigma-Aldrich production synergies (BioPharmaReporter)
  • Websites often promote unproven stem cell therapies (Reuters)
  • FDA's Priority Reviews May Have Helped Reduce New Drug Shortages (Pink Sheet-$)
  • PhIIb miss muddies waters ahead of AbbVie opt-in decision on RA drug (Fierce)
  • FDA panel to discuss Dynavax's Heplisav-B (BioCentury)
  • Aldeyra Surges on New Data, Another Step For Inflammation Drug (Xconomy)
  • PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination (FDA)
  • Pfizer's Vyndaqel a success for rare disease (EPR)
  • Pharma brings the heat in July as TV ad spending soars (Fierce)

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

  • Mesoblast cell treatment shows promise in rheumatoid arthritis : study (Reuters)
  • Coherus' CHS-1420 similar to Humira in Phase III trial (BioCentury) (Biosimilar News)
  • Addressing the Myths About ICER and Value Assessment (ICER)
  • SIGA Announces Data Safety Monitoring Board (DSMB) Approval to Complete Subject Enrollment in the Final Cohort of Phase III Study of TPOXX™ (tecovirimat) (Press)
  • Results from Merck's Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine (Press)
  • Alkermes Submits Supplemental New Drug Application to FDA for Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia (Press)
  • Eagle Pharmaceuticals Reports Positive Outcome From FDA Meeting For RYANODEX For Exertional Heat Stroke NDA Submission (Press)
  • Phase 3 results for Cx601 in treatment of complex perianal fistulas in patients with Crohn's disease (MNT)

US: Medical Devices

  • St. Jude Medical reverses course on covering top execs' tax tabs (MassDevice)
  • FDA Posts Executive Summary of OTC Diagnostic Tests Meeting (FDA)
  • Online marketplace offers cheaper CPAP machines without a prescription (Reuters)
  • BONESUPPORT Receives FDA Approval to Initiate IDE Clinical Study (Press)
  • Boston Scientific wins FDA nod for Emblem MRI S-ICD (MassDevice)

US: Assorted & Governmentw

  • Where low-income insurance options improved, so did results (Reuters)
  • Bayer can't dodge Essure lawsuits in California (MassDevice)
  • AstraZeneca Says Mylan Can't Sell Cancer Generic Till 2019 (Law360-$)
  • BIO Comments on Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule (BIO)
  • Benicar MDL Court: An Unconventional, but Relatively Simple, Remand Decision (Drug and Device Law)
  • Biogen Escapes Negligence Suit Over MS Drug Labeling (Law360-$)
  • Health Affairs' August Issue: Disparities, Hospital Financing, And More (Health Affairs)
  • Bristol-Myers Squibb Settles with California Insurance Commissioner (Policy and Medicine)
  • University of California pays $9m to settle Medtronic InFuse suits (MassDevice)

Upcoming Meetings & Events

Europe

  • NHS England strengthens clinical leadership (OnMedica)
  • EMA Human Medicines Highlights – July 2016 (EMA)
  • Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (EMA)
  • NICE Cerebral palsy: guideline consultation (NICE)
  • Medicines: licensing time-based performance measures (MHRA)
  • Experimental ALS drug wins EU orphan status (PharmaTImes)
  • Medtronic wins CE Mark for SureTune2 DBS software (MassDevice) (Press)
  • Belgium ratifies MEDICRIME Convention (EDQM)
  • InSeal Medical wins CE Mark for vascular closure device (MassDevice)

Asia

  • Utilization of Electronic Study Data: Summary Report of Pilot Project in FY 2015 (PMDA)
  • CyberHeart inks development deal with Japan's National Cancer Center (MassDevice)
  • Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan (Press)

Australia

  • Sponsor transfer and change of sponsor name amendments (TGA)
  • Updated list of 'permissible ingredients' for use in listed medicines (TGA)
  • Compositional guidelines  (TGA)

Canada

Zika

  • Florida is investigating apparent new case of locally transmitted Zika (Reuters)
  • Cayman Islands reports first locally transmitted Zika case: government (Reuters)

General Health & Other Interesting Articles

  • Op-Ed: A Giant Conflict of Interest (Medpage)
  • Michael Phelps Is Getting Some Awful Medical Advice (And Bruises Too) (Forbes)
  • Dr. Weird Al Yankovic Is The Voice Of The Unbreak Healthcare Movement (Forbes)

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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