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Recon: FDA Delays Verdict on Allergan’s Esmya

Posted 01 March 2018 | By Ana Mulero 

Recon: FDA Delays Verdict on Allergan’s Esmya

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

In Focus: US
  • FDA is Driving the Manufacture of Drug Products Outside the United States (FDA Law Blog)
  • Mylan: Generic competition pushes EpiPen sales down (MassDevice) (Reuters) (CNBC)
  • Alphabet-Backed Startup Clover Health Posts $22 Million Loss in 2017 (Bloomberg)
  • Novartis wants to be a leader in a new generation of prescription digital med programs, pairs with Pear (Endpoints News) (pharmaphorum) (Press)
  • Mylan teams up with Revance on biosimilar for Botox (Reuters) (Press) (Fierce)
  • The power of a patent: Will a new Trump appointee chip away at pharma’s monopolies? (Stat News-$)
  • Califf: The U.S. Opioid Crisis: Digital Tools, Data-Driven Approaches, and New Ways of Thinking About Public Health Challenges (Duke)
  • FDA delays verdict on Allergan's Esmya as European liver safety review pends (Fierce)
  • 23andMe is getting more specific with its DNA ancestry tests, adding 120 new regions (CNBC)
  • GAO to probe Trump's response to opioid crisis (Politico)
In Focus: International
  • Takeda to add plant, 70 jobs in Ireland as it builds on deal for TiGenex (FiercePharma)
  • MHRA authorises in vivo genome editing trial (Pharma Times)
  • Research reveals levels of inappropriate prescriptions in England (MHRA)
  • 19 new psychoactive substances added to Narcotics List (Swissmedic)
  • AMRI expanding testing services in the EU (In-Pharmatechnologist)
  • MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies (Emergo Group)
Pharmaceuticals & Biotechnology
  • Activist Alex Denner to gain board control at Medicines Company (CNBC)
  • STING fever is sweeping through the cancer immunotherapy world (C&EN)
  • Biotech is full of chest-thumping press releases. This one thumps really hard (Stat News)
  • Rubius raises $100M in crossover round as cell therapies near human testing (FierceBiotech)
  • Congress Can Find Consensus On Drug Pricing By Targeting Cost Drivers – Waxman (The Pharma Letter-$)
  • Grassley Introduces Bill to Bring Transparency to the 340B Prescription Drug Program (Press)
  • Interview – Bayer’s need for deals grows (EP Vantage)
  • Rare Disease Supporters Suggest Permanent PRV Program, Even If It May Concern FDA (Pink Sheet-$)
  • With $36M series B, Finch goes full speed ahead in microbiome therapy (FierceBiotech)
  • Maybe There is a Reason After All!! (Lachman Consultants)
  • Big pharma, big data: why drugmakers want your health records (Reuters)
  • FDA must step up on rare diseases after cuts to Orphan Drug Tax Credit (The Hill)
  • Oxford BioTherapeutics raids Celgene for CMO as I-O trial plan takes shape (FierceBiotech)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Takeda-partnered Finch Therapeutics grabs $36M and looks to leapfrog the pack in microbiome R&D (Endpoints News)
  • Study Assesses Newborns with Suspected Rare Diseases (Press)
  • Weighing the Risks and Benefits of Hormonal Contraception (JAMA)
  • NICE Positive Recommendation Supports Use of Bavencio for Treatment of Adults in England, Wales and Northern Ireland with Metastatic Merkel Cell Carcinoma, a Rare Skin Cancer (Press)
  • Watch out Endo: Sorrento is after your $1B+ drug with FDA OK of ZTlido (Endpoints News)
  • PPD to run ‘patient concierge’ trial service (Fierce)
Medical Devices
  • LivaNova shares up on topped Q4, 2017 earnings (MassDevice) (Press)
  • Philips launches HealthSuite Insights AI-powered healthcare app marketplace (MassDevice) (Press)
  • Stryker completes acquisition of Entellus Medical (Press)
  • InterSystems Launches FHIR Sandbox for Application Development Beyond the EHR (Press)
  • Dexcom Shows It Can Still Hang With Abbott (MD+DI)
  • Medtechs turn away from the US exchanges (EP Vantage)
  • StimGuard launches head-to-head trial against Medtronic’s InterStim (MassDevice)
  • Covance Enters into Strategic Technology Agreement with GSK (Press)
  • Challenges When Designing a Mobile Medical App for Safe and Effective Use (Emergo Group)
  • Docent Health Chooses mPulse Mobile to Scale and Deepen Their Personalized Healthcare Journeys (Press)
  • Teladoc taps IBM Watson machine learning for second opinion service (mobihealthnews)
  • Siemens Healthineers Launches ACUSON Juniper Next-Generation Ultrasound System (Press)
  • Real-time glucose monitor helps people with risky diabetes problem (Reuters)
US: Assorted & Government Upcoming Meetings & Events Europe
  • Life expectancy in England and Wales shortens: research (Reuters)
  • Genome sequencing project reaches the halfway mark (MHRA)
  • EMA to move into permanent Amsterdam premises in November ‘19 (Focus)
  • New technology supports new mums to breastfeed (MHRA)
  • Motus GI wins CE Mark for Pure-Vu system (MassDevice)
  • Brexit and patient access to medical research (The Pharma Letter)
  • Median, CMIC join forces on oncology clinical trials in East Asia (FierceBiotech)
  • NEW: IPC-EDQM Joint Symposium on "Drug Standards and Regulatory Updates" (EDQM Council of Europe)
  • NPPA Chairman paid ‘price’ for trying to Control price of treatment (Medicare News)
  • Prescription medicines: registration of new generic medicines and biosimilar medicines (TGA)
  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)
  • No room in health system for private eye surgery clinics, says Canadian Health Coalition (CBC News)
  • 5 pharmacare questions and answers (CBC News)
General Health & Other Interesting Articles
  • Barbra Streisand Cloned Her Dog. For $50,000, You Can Clone Yours. (The New York Times)
  • Another reason to worry about overcrowded emergency rooms (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.
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