Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment Alexion C-Suite Overhaul (23 May 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

• Sanofi and Regeneron: FDA Approval of Kevzara (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients (Press) (Endpoints) (Reuters)
• Trump’s 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fees (Focus) (WSJ-$)
• Puma Biotech Shares Are Roaring On An FDA Review. Here's What Could Still Go Wrong (Forbes) (Fierce) (Briefing Docs)
• FDA Ad com for Hospira’s proposed biosimilar to Epogen/Procrit (epoetin alfa) (Briefing Docs)
• Different types of bills aimed at curbing high drug prices proceed in two states (Stat-$) (Fierce)
• Alexion's C-suite overhaul continues as CFO, R&D chief exit, new commercial head enters (Fierce) (Press) (Endpoints)

In Focus: International

• Japan to bring forward target for increased generic drug use: sources (Reuters)
• India's Government Plans to Expand Its Drug Regulator (Bloomberg)
• UK competition watchdog accuses Merck of obstructing biosimilars (Reuters)
• EMA to Launch Revamped EudraVigilance (Focus)
• NHS could lose more than 2,000 GPs through Brexit (PharmaTimes)
• Australia Considers Allowing Marketing of Devices Approved Overseas (Focus)
• US drug prices are so high that Canada wants other countries as reference points (Stat-$) (Focus)
• EMA closed from 18:30 on Wednesday 24 May until 7:30 on Monday 29 May 2017 (EMA)
• Merck's Gardasil preps for head-to-head with GSK’s Cervarix in China, with big sales targets ahead (Fierce)

Pharmaceuticals and Biotechnology

• Bioverativ to buy True North for $400M upfront (Fierce) (Endpoints)
• A new approach to Alzheimer’s treatment (Scientific American)
• Bain Capital raises $720m life sciences fund (Mass Device) (Endpoints)
• Should Everyone With Heart Failure Get Aggressive Treatment? (CardioBrief)
• ACRO Opposes “Right to Try” in Policy Statement (Press)
• 5 Key Debates Over FDA's Interchangeable-Biosimilar Views (Law360-$)
• GE Looks to Single-Use Modular BioParks (BioPharma-Reporter)
• Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu (Mass Device)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

• Heart safety clouds hopes for Amgen, UCB bone drug approval (Reuters)
• Merck says Afferent’s chronic cough drug clears mid-stage trial (PMLive)
• FDA Grants Priority Review to Merck’s sBLA for Keytruda (pembrolizumab) for Treatment of Recurrent or Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Press)
• FDA Approval Summary for Pembrolizumab (The Oncologist)

Medical Devices

• Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo (Mass Device) (Press)
• Symic Bio raises $30m for peripheral vein graft failure therapy (Mass Device)
• Novartis’ Ultibro Breezhaler tops corticosteroid for COPD in head-to-head study (Mass Device)
• V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down (FDA)

US: Assorted and Government

• White House dials back cuts to drug control office (Politico)
• House to Examine Zika Virus and State of Public Health Response for Potential Outbreaks (E&C)
• The Supreme Court Refuses to Hear Park Doctrine Case (FDA Law Blog)
• FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue (FDA)
• FDA Drug Safety Communication: FDA warns about risk of accidental overdosing of dogs with the drug Sileo (dexmedetomidine oromucosal gel) (FDA)
• FDA to Drug Manufacturers: Beware Water-Borne Contaminants (Focus)

Upcoming Meetings and Events               

• RAPS' FDA Advisory Committee Meeting Tracker

General Health and Other Interesting Articles

• German court favors vaccination of child in parents' dispute (Reuters)
• $400 billion price tag for California single-payer bill (AP)
• Scientific advice — is drug repurposing missing a trick? (Nature Reviews-$)
• Kenyan medics say U.S. health aid cuts will mean more abortions (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? Send him an email at [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.