Recon: FDA Delays Verdict on Allergan’s Esmya

• 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)

• 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)

• 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)

• 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)

• 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)

• CVS/Aetna Merger Received Warmly at House Hearing (MedPage Today) (FierceHealthcare)
• For the Cosmetics Industry, a Regulatory Makeover Awaits (The Wall Street Journal)
• US regulators greenlight Luxottica-Essilor merger (Financial Times) (Press) (FTC)
• USPTO Issues Memo Clarifying Written Description Guidance (Patent Law Weblog)
• SEC’s updated cybersecurity guidance could have implications for healthcare M&A (FierceHealthcare)

• FDA Advisory Committee Calendar

• 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)

• 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)