Regulatory Focus™ > News Articles > Regulatory Recon: New Treasury Dept. Rules Could Threaten Pfizer-Allergan Merger, FDA Posts Briefing

Regulatory Recon: New Treasury Dept. Rules Could Threaten Pfizer-Allergan Merger, FDA Posts Briefing Documents for Intercept's PBC Drug (5 April 2016)

Posted 05 April 2016 | By Michael Mezher 

Regulatory Recon: New Treasury Dept. Rules Could Threaten Pfizer-Allergan Merger, FDA Posts Briefing Documents for Intercept's PBC Drug (5 April 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

In Focus: International

  • ATMOSPHERE: Heart Failure Trial Poisoned By Controversy (CardioBrief) (NEJM) (Novartis, EU Regulator Reply)
  • Eisai's Halaven recommended for European approval (Pharmafile) (Press)
  • Better safety for patients through EU-funded research (EMA)
  • Draft Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDD) (Health Canada)
  • Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device (MassDevice) (Reuters)
  • EDQM's International API Convergence Efforts Encompass Generics Regulator Forum IGDRP, Monographs and Inspections (IPQ)
  • Mexican Official: Not Much Wiggle Room On Biologics In TPP (Law360-$)
  • Swiss To Offer More Data Protection For New Indications, Orphans, Pediatric Drugs (SCRIP-$)
  • Russia designs scheme for compulsory licensing of imported drugs (PharmaLetter-$)

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US: Pharmaceuticals & Biotechnology

  • The Future of the FDA: A Clinical Research Associate's Perception (MassDevice)
  • Harvard, Tufts med students stage protest at 'biased' $2.9B drug development figure (Fierce) (The Harvard Crimson)
  • FDA Differentiates Biosimilar Labeling from Generic Drug Labeling (National Law Review) (Focus)
  • Would Pfizer and AstraZeneca Both Revisit That $100 Billion Deal? (Forbes)
  • More People Should Consider Cholesterol Pills, Study Says (Forbes)
  • Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest (NIH)
  • Additions To Interoperability Guidance Proposed By FDA Reviewer In Likely Internal Agency Recommendation (Gray Sheet-$)
  • Long-acting Opioid Addiction Treatment Reduces Relapse Risk (DD&D)
  • A family-run drug maker faces tough choices to stay afloat in the Shkreli era (STAT)
  • Academia And Industry Do Not Need To Be At Odds With Each Other (Forbes)
  • FDA Describes Emergency-Use Authorization Process In Draft Guidance (Gray Sheet-$)
  • Shire Targets SHP465 ADHD Resubmission 10 Years After Initial Filing (Pink Sheet-$)
  • UC Prof Fudged Painkiller Data, Drugmaker Alleges (Law360-$)

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

  • Pediatric data add to Shire's ADHD package (BioCentury)
  • New data from Zafgen's Prader-Willi study (BioCentury)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Announce First Patient Treated in Phase III Combination Study with Avelumab and INLYTA in Renal Cell Carcinoma (Press)
  • Pfizer Announces Positive Top-Line Results from the First Phase 3 Trial of Investigational Tofacitinib in Adults with Psoriatic Arthritis (Press)
  • Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR (Press)
  • Motus' relamorelin hits anorexia, gastroparesis milestones (BioCentury)
  • ANI Pharmaceuticals Announces FDA Approval of Oxycodone Capsules, 5mg (Press)
  • Ironwood Pharmaceuticals Reports Top-Line Data from Exploratory Phase IIa Study of IW-9179 in Diabetic Gastroparesis (Press)
  • Braeburn Pharmaceuticals and Camurus announce Enrollment goals reached in two pivotal Phase 3 Trials of CAM2038 for treatment of opioid dependence (Press)
  • Ongoing Phase II Study of Evenamide (NW-3509) May Suggest an Alternative Approach to the Treatment of Schizophrenia (Press)
  • Kiadis Pharma presents positive data on the primary endpoint of its single dose
  • Phase II trial with ATIR101 (Press)

US: Medical Devices

  • FDA clears CardioFocus' HeartLight ablation system (MassDevice)
  • Three reasons to be optimistic about bioresorbable stents (MassDevice)
  • Will FDA Approve Edwards' Clinically Superior Sapien 3 Valve Faster? (MDDI) (WSJ-$)
  • ConforMIS yanks FDA clearance bid for iTotal hip, shares slide (MassDevice)
  • Navidea to seek rheumatoid arthritis indication for Lymphoseek (MassDevice)
  • Fire & Ice: Medtronic's Arctic Front ablation catheter as good as BioSense Webster's ThermoCool (MassDevice) (Press)
  • First-Ever Medtronic Harmony Transcatheter Pulmonary Valve Data Shows Positive Procedural Success In Early Feasibility Study (Press)
  • Ekso GT Robotic Exoskeleton Cleared for Stroke Rehab, Spinal Cord Injuries (MedGadget)
  • DICOM Grid Announces FDA Approval Of Next Generation Cloud PACS And Zero-Footprint Diagnostic Viewer (Press)

US: Assorted & Government

  • If Healthcare Prices Emerge, Americans Won't Link To Quality (Forbes)
  • Biosimilar Notice Rule Isn't Absolute, Apotex Tells Fed. Circ. (Law360-$) (SCRIP-$)
  • Jury Finds Tyco Not Liable In $60M Drug Heist Trial (Law360-$)
  • Valeant Says No More Restatements, to File 10-K by April 29 (Bloomberg)
  • Making the Price Right: Ideas To Change Drug Costs Gain Momentum (Xconomy)
  • US patent lawsuit filed against Genmab and Janssen regarding Darzalex (PharmaLetter-$)
  • SAMHSA's Proposal to Increase Buprenorphine Patient Limit: Panacea or Placebo? (FDA Law Blog)
  • US to pay more to insurers who provide Medicare Advantage in 2017 (MassDevice) (WSJ-$)
  • A Perilous Proposal To Privatize Veterans' Care And End The VA (Forbes)
  • Bauman Personal Jurisdiction In-House Counsel Checklist (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Points to be considered by applicants to the Horizon 2020 topic: New therapies for rare diseases (EMA)
  • Europeans spend 24 billion euros on narcotics each year: report (Reuters)
  • EU Medtech Reform: Device Makers Warned They May Need A New Notified Body (SCRIP-$)
  • Ukraine Device Conformity Assessment System On Track But Challenges Lie Ahead (SCRIP-$)
  • EU Notified Bodies Group Revises Code To Protect Clients, Support Harmonization (Clinca-$)
  • Russia's Pharmasyntez eyes US and EU expansion (PharmaLetter-$)
  • EU Council's Authorized Rep Liability Demands: Counter-Arguments, Alternatives, And Threat To TTIP (Clinca-$)
  • Catalent: Limited production begins at suspended French softgel plant (In-PharmaTechnologist)
  • Rusan Pharma plant still breaks GMP rules says UK MHRA (In-PharmaTechnologist)
  • EFPIA and CPIA Join Together to Host EU/China Regulation Event (EFPIA)

India

  • Health ministry issues Guidelines on 'Similar Biologics' to lay down regulatory pathway for marketing authorisation in India (PharmaBiz) (Focus)
  • SC seeks health ministry's response on adulteration allegations against Ranbaxy (Economic Times)
  • Indian drug firms to face challenges in US market: ICRA (Economic Times)
  • Drug ban: Inform states about relief to pharma companies, HC tells Centre (Economic Times)
  • India Pharma Stocks Bleed Amid Rising FDA Violations (PharmAsiaNews-$)
  • Mumbai-based Lupin looks at buyouts in Japan after Sun Pharmaceutical's entry (Economic Times)
  • Delhi High Court directs ESIC to provide treatment to 3 children with rare diseases free of cost (PharmaBiz)
  • Hyderabad-based drugmaker Gland Pharma attracts bids from Torrent Pharma and Baxter (Economic Times)
  • Aurobindo Pharma gets USFDA nod for generic anti-infective drug (Economic Times)
  • Form 483s issued last year show Indian companies had high level of data integrity issues (PharmaBiz)

Canada

Australia

  • Reasons for scheduling delegate's interim decision and invitation for further comment for the ACMS meeting, April 2016 (TGA)

Zika

  • Zika Vaccine Could Solve One Problem While Stoking Another (Scientific American)
  • CDC Adds Fiji to Interim Travel Guidance Related to Zika Virus (CDC)
  • CDC Adds Kosrae to Interim Travel Guidance Related to Zika Virus (CDC)

Other International

  • Yellow Fever Outbreak in Angola Strains Health Organizations (NYTimes)
  • Pharma in Indonesia: 11th economic stimulus package issued (PharmaLetter-$)
  • ISO Issues First Application-Specific Standard on Small Bore Connectors, Others In Pipeline (SCRIP-$)
  • Martindale Pharma expanding Middle East business (PharmaLetter-$)
  • Health standards for World Health Day (ISO)

General Health & Other Interesting Articles

  • Reproductive technology tied to higher risk of birth defects (Reuters)
  • The disturbing reason some African American patients may be undertreated for pain (Washington Post)
  • Climate change threatens hearts, lungs but also brains: U.S. study (Reuters)
  • Potential Pathway for Emergence of Zoonotic Malaria is Identified (ICT)

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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