Regulatory Focus™ > News Articles > Regulatory Recon: FDA AdComm Backs Teva Abuse-Deterrent Opioid; Expert Panel Endorses Gene Drive Tec

Regulatory Recon: FDA AdComm Backs Teva Abuse-Deterrent Opioid Expert Panel Endorses Gene Drive Technology (8 June 2016)

Posted 08 June 2016 | By Michael Mezher 

Regulatory Recon: FDA AdComm Backs Teva Abuse-Deterrent Opioid Expert Panel Endorses Gene Drive Technology (8 June 2016)

Welcome to Regulatory Reconnaissance, your daily 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

  • Nobody Should Have Any Certainty About Sarepta (Forbes)
  • Here's What's Next For Cancer-Killing T-Cells After Strong ASCO Showings (Forbes)
  • Globalization and FDA's New Partnerships to Ensure Product Safety (FDA Voice)
  • FDA panel backs Teva's abuse-resistant opioid painkiller (Reuters) (Tarius) (Medpage)
  • Get Out Of The Way Of Human Genetic Engineering? Unwise And Uncalled For (Forbes)
  • Pharma Group, Under Pressure, Punches Back on Prices (Bloomberg)
  • Panel Endorses 'Gene Drive' Technology That Can Alter Entire Species (NYTimes) (STAT) (Press)
  • Meet the Moralist Policing Gene Drives, a Technology That Messes with Evolution (MIT Technology Review)
  • FDA's Califf speaks to patient engagement, off-label communications (BioWorld) (Pink Sheet-$)
  • J&J, GSK rheumatoid arthritis drug meets goals of large trial (Reuters) (Fierce)
  • Senators Question Pfizer, Mylan and Three Other Companies Over Opioid Overdose Treatment Price Hikes (Focus)
  • ICER Releases Evidence Report on Diabetes Prevention Programs (ICER)
  • Wearable artificial kidney offers hope for dialysis patients (Reuters)
  • Theranos's Massive Problems May Not Spell the End of the Company (The Street)
  • Genomic Data Commons heralds new era of data sharing for cancer research (University of Chicago)

In Focus: International

  • Set your watches: Expected timing of European Medical Device Regulations (Emergo)
  • WHO to consider new evidence on Zika, Olympics next week (Reuters)
  • FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations (Focus)
  • EMA portal will make EU more attractive for drug research says EUCROF (In-PharmaTechnologist)
  • Asia Regulatory Roundup: China's Anti-Corruption Agency Chides CFDA Over Loopholes (Focus)
  • TTIP negotiators mull end of duplicate US, EMA facility inspections (In-PharmaTechnologist)
  • Roche says combination therapy with its Avastin and Tarceva gets European backing for lung cancer treatment (Pharmafile) (Press)
  • Novartis plans head-to-head trial for Cosentyx and Humira (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Exploring the disruptive potential of synthetic biology (McKinsey&Co)
  • FDA Warns of Heart Risk with Loperamide Overdose (Medpage)
  • Harvard Unveils $15M Life Lab to House Biotech and Medical Startups (Xconomy)
  • Human Connectome Project marks its first phase (NIH)
  • Big Pharma Is Bulking Up For Superbug Sweepstakes (Forbes)
  • BIO 2016: Concussions, Ali, FDA and synthetic biology (MedCityNews)
  • ASCO Round-Up: Array, Kite, Exelixis, Pfizer/Merck KGAA, Mylan, Novartis (Pink Sheet-$)
  • Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers (NIH)
  • Prominent Cardiologist And ESC Presidential Candidate Found Guilty Of Fraud (CardioBrief)
  • ARC, FDA continue exchanging ideas on amyloidosis (BioCentury)
  • Genentech to pay $67 million to settle allegations it misled docs about cancer drug (Modern Healthcare)
  • Boston Startup Raises $100 Million To Use Synthetic Biology To Design Microbes For Industry (Forbes)
  • Beyond the Cutting Edge: How to Enable Life Sciences Organizations Today for the Societal Challenges of Tomorrow (BIO)
  • FDA Commissioner Califf to Industry at #BIO2016: Talk to Patients (BIO)
  • Strengthening the Reporting of Observational Studies in Epidemiology—Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement (PLOS)
  • Impact Evaluation of a System-Wide Chronic Disease Management Program on Health Service Utilisation: A Propensity-Matched Cohort Study (PLOS)
  • Lupin recalls over 54K vials of anti-bacterial injection in US (Economic Times)
  • Will Humans One Day Regenerate Lost Limbs And Diseased Organs? (Forbes)
  • How to Make Healthcare Better? Make It Easy (Xconomy)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ALPROLIX (FDA)
  • Certara and the FDA Extend Their Partnership to Develop PBPK Models to Support Veterinary Drug Evaluations (Press)

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

  • Data shows around a third of advanced kidney cancer patients still alive at five years with Opdivo (nivolumab) (MNT)
  • Remedy Pharmaceuticals Receives FDA Fast Track Designation for CIRARA (Press)
  • Bristol-Myers Squibb Announces New Rheumatoid Arthritis Research and Real-World Data at the Annual European Congress of Rheumatology (EULAR 2016) (Press)
  • Relmada Therapeutics' d-Methadone Receives Orphan Drug Designation for Management of Postherpetic Neuralgia (Press)
  • Sage Reports Positive Top-line Results from Phase 1 Clinical Program of SAGE-217 (Press)
  • Catabasis shares decimated after LDL drug fails PhIIa trial (Fierce) (Press)
  • Pfizer Research Advances Body Of Evidence For Tofacitinib Citrate (XELJANZ) Providing Clinicians With Additional Information For The Treatment Of Moderate to Severe RA (Press)
  • GenSight Biologics Announces Additional Promising Results of Its Phase I/II Study with GS010 for the Treatment of Leber's Hereditary Optic Neuropathy (LHON) (Press)
  • Trevena, Inc. Announces First Patients Enrolled in the APOLLO-1 and APOLLO-2 Phase 3 Pivotal Efficacy Studies of Oliceridine in Acute Pain (Press)
  • Millendo Therapeutics Announces Initiation of Phase 2 Clinical Trial of ATR-101 in Patients with Congenital Adrenal Hyperplasia (Press)

US: Medical Devices

  • First Surgical Robot from Secretive Startup Auris Cleared for Use (IEEE Spectrum)
  • Investigator Horror Stories: Industry Insiders Tell Of FDA Inspectional Nightmares – And How Device Firms Handled Them (Gray Sheet-$)
  • Fresenius, Smiths in the hunt for Pfizer's $1.5B infusion pump biz (MassDevice)
  • B. Braun files IV cath patent infringement suit against Becton Dickinson (MassDevice)
  • Zimmer Biomet Buys LDR To Boost Spine Revenue Growth (Gray Sheet-$)
  • Study shows no increased cancer risk with Medtronic's InFuse (MassDevice)
  • Medtronic expects rev from surgical bot system by FY2019 (MassDevice)
  • MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw (Press)
  • Medtronic Announces Results of Early Feasibility Studies Supporting New Approach to ICD Therapy During Cardiostim 2016 (Press)

US: Assorted & Government

  • Senate Approves Update of Toxic-Chemical Regulations (NYTimes)
  • Minnesota Gives Us Another Excellent Preemption Decision (Drug and Device Law)
  • D. Mass. (!) Refuses to Certify Celexa/Lexapro RICO Class Action (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Micro Interventional wins CE Mark for Permaseal transapical closure device (MassDevice)
  • Industry Proposes Pragmatic Fixes For EU Regulation Of ATMPs (SCRIP-$)
  • EBE and EFPIA Applaud EMA Initiative to Improve Pathway for Advanced Therapy Medicinal Products (ATMPs) (EFPIA)
  • ABPI appears before House of Lords Committee to back the continued autonomy and "crucial role" of Innovate UK (ABPI)
  • Mediven gets CE-IVD mark for molecular diagnosis kits (BioSpectrum)

India

  • Cipla hires Kedar Upadhye from Dr. Reddy's as global CFO (Economic Times)
  • Sun Pharma enters dermatology segment to expand retail offering (Economic Times)
  • Robust pharmacovigilance system needed to report ADRs: Prof Aziz (PharmaBiz)
  • Pharmexcil to meet DCGI to discuss renewal of WC certificates on API exports to EU (PharmaBiz)
  • Pharma cos yet to opt for right chemical indicator for sterilization process of products: Expert (PharmaBiz)

Australia

  • Australian Govt Needs To Tackle Low Biosimilar Awareness And Switching Concerns (SCRIP-$)

Zika

  • Could Cancelling The Olympics For Zika Do More Harm Than Good? (Forbes)

Other International

  • WHO validates countries' elimination of mother-to-child transmission of HIV and syphilis (WHO)

General Health & Other Interesting Articles

  • The New Economics of Cybercrime (The Atlantic)
  • Fighting Lyme Disease in the Genes of Nantucket's Mice  (NYTimes)
  • Scientists Seek Genetic Clues To Asthma's Toll On Black Children (NPR)
  • U.S. panel reaffirms syphilis screening advice as infections rise (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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