Regulatory Focus™ > News Articles > Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Cur

Regulatory Recon: Trump Showcases Corning Drug Packaging Investment MHRA To Relocate Near EMA's Current Offices (21 July 2017)

Posted 21 July 2017 | By Michael Mezher 

Regulatory Recon: Trump Showcases Corning Drug Packaging Investment MHRA To Relocate Near EMA's Current Offices (21 July 2017)

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

In Focus: US

  • Trump unveils companies' $500 million U.S. drug packaging project (Reuters) (STAT) (CNBC) (Pharmafile)
  • A Drug Maker Spends Big in Washington to Make Itself Heard (NYTimes)
  • White House developing comprehensive biosecurity strategy: official (Reuters)
  • Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge Lantus (Fierce) (Reuters)
  • FDA Funding Bill Advances in the Senate (FDA News-$)
  • Ironwood slips as heartburn data underwhelm investors  (Fierce)
  • AstraZeneca CEO reassures staff, aims to be at September cancer meet (Reuters) (Fierce)
  • Latest Senate healthcare bill would leave 22 million without insurance: CBO (Reuters)
  • 7 Trends On How Big Pharma Uses Social Media (Forbes)
  • One big cancer breakthrough is likely on the way to patients. Here's what may be coming next (STAT)
  • 87 experimental therapies for glioblastoma are in the works. Some might help McCain now (STAT)
  • Glioblastoma: Here's The Science Behind Senator McCain's Tough Diagnosis (Forbes)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

In Focus: International

  • EU nod for Vifor's Veltassa (PharmaTimes)
  • Trade group defends its transparency regarding meetings with EMA (PharmaLetter-$) (EFPIA)
  • MHRA to move HQ to same area as EMA's London digs (Fierce) (Pink Sheet-$)
  • Malaysian MDA Lists Documentation Necessary for Exemptions from Medical Device Registration (Emergo)
  • Canada pushed to take federal action against Purdue over OxyContin marketing (Fierce)
  • GSK recruits a star cancer scientist to its board ahead of R&D reorganization (Endpoints)
  • NICE publishes new Parkinson's clinical guidance (EPR)
  • HIV drug resistance could undermine progress in AIDS battle: WHO (Reuters)
  • Dompé gains EC approval for rare eye disease drug (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • An upstart in the polyclonal antibody biz just lined up $50M for its plan to disrupt a multibillion-dollar business (Endpoints)
  • FDA and Drug Pricing: Lowering The Cost of Capital – Not The Cost Of Drugs (Pink Sheet-$)
  • FDA Extends Expiration Dates of Sodium Bicarbonate Injectables in Shortage (FDA News-$)
  • Generic Firms Want Looser Bioequivalence, But Change May Be Difficult For FDA (Pink Sheet-$)
  • Covis Pharma taps Verify ahead of the extended DSCSA mandate ( Outsourcing Pharma)
  • Teligent Shares Rise on FDA Approval for Erythromycin Topical Gel (The Street)
  • Akorn shareholders approve merger deal with Fresenius Kabi (Drug Delivery)
  • Catalent, Rutgers partner to study pediatric drug formulation and delivery (Drug Delivery)
  • FGF19 reduces muscle wasting (Nature)
  • Neutrophils deliver the goods (Nature)
  • CSL launches Cinryze rival Haegarda despite Shire's best efforts—at a big discount, too (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Amgen and Novartis ID the finish line in a wicked scramble for first CGRP migraine drug OK (Endpoints) (GEN) (Press)
  • Braeburn, Camurus Send Long-Acting Opioid Addiction Treatment to FDA (The Street)
  • NDA filing accepted for Yonsa by the US FDA (PharmaLetter-$)
  • U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia (Press)
  • Samumed Successfully Completes Phase I Study for Potential Topical Treatment for Chronic Tendinopathy (Press)
  • GSK Submits EU Filing for Extended Use of Relvar Ellipta in Patients with Controlled Asthma on an ICS/LABA Combination (Press)
  • CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) (Press)
  • Syros Publishes Foundational Data Supporting Ongoing Phase 2 Clinical Trial of SY-1425 for Genomically Defined AML and MDS Patients (Press)

Medical Devices

  • Class 1 Device Recall Penumbra 3D Revascularization Device (FDA)
  • DarioHealth gets clearance from FDA for Android app, expects to increase U.S. market share (MobiHealthNews)
  • TSO3 files FDA app seeking duodenoscope indication for Sterizone VP4 sterilizer (MassDevice)
  • Masimo wins CE Mark for RPVi (MassDevice)

US: Assorted & Government

  • Pfizer CEO: The Future Of American Innovation Rests On A Competitive U.S. Tax Policy (Forbes)
  • Current Trends In Biologics-Related Inter Partes Reviews (Law360-$)
  • The Trump Administration's Intellectual Property and Competition Objectives for NAFTA Renegotiation: What Was Wrong with the TPP? (Patent Docs)
  • DEA Announces "Groundbreaking" Guidance that is Inconsistent with the Settlement they are Announcing – Time at Last for Rulemaking? (FDA Law Blog)
  • Guest Post − West Virginia Court Finds Both Fraudulent Joinder & Misjoinder in Opioid Action (Drug & Device Law)

Upcoming Meetings & Events

Europe

India

  • USFDA completed audit of Mexican plant: Dr Reddy's Laboratories (Economic Times)
  • Pharma industry needs vocational specific training in mfr & marketing: Sumit Kumar (PharmaBiz)

Australia

  • TGA presentation: Prescription medicines minor variations e-Form: Information sessions, 3 and 5 July 2017 (TGA)

General Health & Other Interesting Articles

  • Coffee with Viagra-like ingredient recalled after FDA discovery (Washington Post)

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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