Recon: J&J to Sell Sterilization Unit to Fortive for $2.7B

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

In Focus:

A Promising Cancer Treatment Made Patients Worse, Not Better (NYTimes)
Johnson & Johnson to sell sterilization unit to Fortive for $2.7 billion (CNBC)
Boston U. boosts lung cancer research with Johnson & Johnson (AP)
Trump's plan to reorganize HHS draws praise, caution (Politico)
Lawmakers advocate for new antibiotics, but stop short of offering incentives (STAT) (Pink Sheet-$)
The 'Right to Try' Law Says Yes, the Drug Company Says No (WSJ)
Drug Shortages Remain 'Serious Concern,' FDA Deputy Says (Bloomberg)
Alex Azar, Health Secretary, Denies Sabotaging Insurance Markets (NYTimes)
Trump Signs Pediatric Cancer Research Bill Into Law (BioCentury)
HHS To Allow Insurers' Workaround On 2019 Prices (KHN)
The Gates Foundation rolls outs details of its new biotech, one without a profit motive (STAT)
Buffett, Dimon and Bezos find the person they want to fix health care (CNBC)
US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs (Pink Sheet-$)
Drug Co. Lundbeck To Settle Charity Support Probe For $52M (Law360-$)
Biogen inks $357M option deal for TMS' stroke drug (Fierce)
That big Biogen deal you were waiting for? Keep waiting (Endpoints)
How An Old Diabetes Drug Made A Big Splash At The Biggest Cancer Confab (Forbes)

In Focus: International

Pfizer Submits Talazoparib to FDA, EMA for Breast Cancer (Endpoints) (BioCentury) (Press)
Can Hong Kong lure biotech without inflating a bubble? (STAT)
Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience (EMA)
DRC Approves Investigational Ebola Treatments (BioCentury)
Drugs for rare diseases will help propel pharma sales to $1.2trn by 2024; report (PMLive)
Merck's Brexit contingency plan? Stockpile medicines (PMLive)
Bayer closes Monsanto acquisition (Press)
Boehringer's Spiriva gets UK license for young asthma patients (PharmaTimes)
Indo-Korean Pharma Linkages: A New Emerging Asian Front? (SCRIP-$)
EU Looks To eFormats To Improve Accessibility Of Medicines Info (Pink Sheet-$)
UK Pharmacovigilance Inspectors Report Drop In Critical Findings For Third Year In Row (Pink Sheet-$)
Singapore's HSA Implements Major Medical Device Regulatory Changes (Emergo)
South Africa's "Landmark" IP Policy To Stop Country "Blindly Handing Out Patents" (Pink Sheet-$)

Pharmaceuticals & Biotechnology

Farewell to Zafgen: A Personal Reflection On Board Evolution (LifeSciVC)
Forty Seven springs out of the blocks ahead of IPO (Pharmafile)
30 years is too long to wait for new medicines. There are ways to speed up drug development (STAT)
Drug combination better for restoring womb after miscarriage (Reuters)
Celltrion gets into outsourcing with Bio CDMO launch (OutsourcingPharma)
On an executive hiring spree, Sarepta snags Biogen's Gilmore O'Neill as new CMO (Endpoints)
Stage Zero Disease And Technology's Shift From Intervention To Prevention (Forbes)
To get around pharmacy gag rules, ask about drug costs (CNBC)
Migraine Breakthrough: Not So Fast (Forbes)
Notorious activist investor Carl Icahn buys small stake in Allergan (Endpoints)
BIO Notebook Day 1: Other Therapeutic Areas Left Behind As Deal-Making, Financing Focus On Oncology, Rare Diseases (SCRIP-$)
BIO Notebook Day 2: Levin Scolds Industry For Squandering Proceeds From US Tax Reform (SCRIP-$)
BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies (Pink Sheet-$)
Guest Post -- Nanomedicine: A Vast Horizon on a Molecular Landscape – Cosmeceuticals (Patent Docs)
Experts at BIO, ASCO weigh in on CAR-Ts versus bispecific antibodies (MedCity)
Looking Ahead: Emerging Technologies and Quality Standards of Medicines (USP)
Bristol-Myers Squibb to Announce Results for Second Quarter 2018 on July 26 (Press)
Eisai/Biogen Remain In BACE Race As Alzheimer's Contenders Dwindle (SCRIP-$)
Novartis' New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands (SCRIP-$)
US FDA approves Cellectis' third 'off-the-shelf' CAR T-cell candidate for clinical trials (BioPharmaReporter)
Vertex presents new data on Kalydeco at CF conference (TPL)
Metacrine raises $65M to kick off NASH clinical testing (Fierce)
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; Correction (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

Proteostasis Announces Positive Data from Ongoing Phase 1 Study of PTI-801 in Cystic Fibrosis Patients on Background Orkambi® Therapy (Press)
ArQule to Present Clinical Data for its BTK Inhibitor, ARQ 531, at the 23rd Congress of the European Hematology Association (EHA) (Press)

Medical Devices

HHS cybersecurity center so unstable staff don't know if it exists, Congress argues (HealthcareIT)
Exact Sciences, Mayo Clinic Share Data on DNA-Based Liver Cancer Test (Xconomy)
Turning Surgeons Into Innovators Without Taking Them Out of the OR (MDDI)
Does Medtronic's Delay Ensure That Intuitive Will Stay on Top? (MDDI)
Inside Apple's integration with Medisafe, the first test of the Apple Health Records API (mobihealthnews)
Pharma enthusiastic for digital medicine, but some roadblocks remain (mobihealthnews)
CDRH Issues Draft Guidance Regarding Test Reports for Nonclinical Bench Studies in Premarket Submissions (FDA Law Blog)
FDA Grants Breakthrough Designation for AutoGenomics' Infiniti Neural Response Panel (GenomeWeb)
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049 (FDA)
CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy (FDA)

US: Assorted & Government

As opioids legislation gains steam, efforts to address crisis collide with moneyed interests (STAT)
Department Of Justice Files Complaint Against California Hand Sanitizer Company Marketing Unapproved New Drugs (DoJ) (FDA)
Elizabeth Warren and a Scholarly Debate Over Medical Bankruptcy That Won't Go Away (NYTimes)
Health Care CEO and Four Physicians Charged in Superseding Indictment in Connection with $200 Million Health Care Fraud Scheme Involving Unnecessary Prescription of Controlled Substances and Harmful Injections (DoJ)
In Missouri, J&J faces biggest trial yet alleging talc caused cancer (Reuters)
Genentech Wants White & Case To Share Samsung Drug Info (Law360-$)
Daiichi Sankyo near to closing US product liability settlement program (TPL)
Strike Two For Plaintiff in Pennsylvania (Drug & Device Law)

Upcoming Meetings & Events

FDA Advisory Committee Calendar
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting - 25 July 2018

Europe

NICE set to deny access to UK-discovered prostate cancer drug for mHSPC (TPL)
Changes to submission and assessment of maximum residue limits of veterinary medicines in foods (EMA)

Asia

Japan v. China: Becoming two of the largest pharma markets in the world (OutsourcingPharma)
Just China Raises $35M Ahead of Global Trials (BioCentury)
HUA Medicing Planing Hong Kong IPO (BioCentury)

India

Abbott to train 60 Gujarat FDCA drug inspectors to effectively implement new MD Rules (PharmaBiz)

Australia

Hazard alert - firmware update to improve battery performance and cybersecurity (TGA)
Reform of the orphan drug program - End of transition arrangements (TGA)
A side-effect of preventing HIV with PrEP: Less condom use (NBC)

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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