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Recon: Novartis joins exodus out of antibiotics

Posted 12 July 2018 | By Ana Mulero 

Recon: Novartis joins exodus out of antibiotics

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

In Focus: US In Focus: International
  • Exclusive: With U.S. trade under a cloud, China opens to Indian pharma (Reuters) (Global Times)
  • China's appetite for infrastructure investment creates big winners (Nikkei Asian Review)
  • GSK Sells Psoriasis/Dermatitis Candidate Tapinarof to Dermavant (GEN) (BioPharma Dive)
  • Merck inks deal with China's Xian Janssen for type 2 diabetes drug (BioSpace) (Fierce) (EPR)
  • Genmab pays Immatics $54M to form anticancer bispecific pact (Fierce) (GEN) (Endpoints)
  • Was pharma bold enough at Lions Health 2018? (pharmaphorum)
  • Brazil prosecutors allege jailed GE executive helped company partake in medical cartel (Reuters)
  • WHO seeks access to Syrians dying from heat, disease in south (Reuters)
  • Changes to Chinese Medical Device Regulations would Benefit Foreign Manufacturers (Emergo Group)
Pharmaceuticals & Biotechnology
  • The drug pricing playbook: how pharma companies keep costs high (Financial Times)
  • Addyi Rises Again (The Hastings Center)
  • Perspectives on uncritical NYT coverage of cardiac mitochondrial transplant trial (The Niche)
  • A Parallel Universe of Clinical Trials (NEJM)
  • With Revlimid and Pomalyst price increases, could Celgene be next on Trump’s to-call list? (Fierce)
  • 3 Key Lessons From Trump's Drug Price Feud With Pfizer (Fortune)
  • What Pfizer, Trump, and consumers got out of a surprising deal — and what they didn’t (STAT)
  • U.S. ended value-based pricing plan for cancer drug because of doubts it would work (STAT-$)
  • U.S. Insurers Say the Opioid Crisis Might Be Declining (Fortune)
  • Patient Experience: The Future Of Big Pharma Is Software (Forbes)
  • Drug Prices Keep Climbing Even as Trump Steps Up Twitter Threats (Bloomberg-$)
  • Celgene’s Otezla Drug Patent Dispute Swells N.J. Court Docket (Bloomberg-$)
  • Tackling pharma’s predatory research problem (PharmaTimes)
  • VC money booms in Q2, with mega-deals hitting record levels (Endpoints)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Parker Institute scientists herald a cell therapy breakthrough in the lab, using next-gen CRISPR tech to engineer T cells (Endpoints)
  • Common Chemotherapy Drug Is More Effective When Given With Dietary Supplement In Mice (Forbes)
  • Virus-free CRISPR could mean faster, more precise gene editing for T-cell therapies (Fierce)
  • Roche’s Venclexta filed in the US for acute myeloid leukemia (PharmaTimes)
  • Zynerba Pharmaceuticals Announces New FAB-C Phase 2 Open-Label Data in Patients with Fragile X Syndrome (Press)
Medical Devices
  • New Research Provides More Reasons to Repeal the Medical Device Tax (Tax Foundation)
  • NAMSA Launches “Uniquely IVD” Development Services to Expedite In Vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers (NAMSA)
  • Abbott Receives FDA Approval for Next-Generation MitraClip Device to Treat People with Leaky Heart Valves (Press)
  • Medtronic Wins Expanded Indication for SelectSecure MRI SureScan Pacing Lead for His Bundle Site Stimulation (Press)
  • Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody for the Cervical Spine, the EVOL ha-C (Press)
US: Assorted & Government
  • The Trump Administration Is Making Immigrant Parents Pay $800 for DNA Tests to Get Their Kids Back (NPR)
  • DEA aims to stop flow of opioids diverted for abuse (Washington Examiner)
  • DEA Finalizes Prescription Opioid Anti-Diversion Policy (Law360-$)
  • FCC Announces $100M Telehealth Pilot Program (Law360-$)
  • maging technique illuminates immune status of monkeys with HIV-like virus (NIH)
  • NIAID scientists create 3D structure of 1918 influenza virus-like particles (NIH)
  • Why Monsanto Could Soon Get Hit With a Flood of Cancer-Related Lawsuits (Fortune)
  • Michigan Approves 11 New Conditions for Medical Marijuana Treatment (Fortune)
  • Democrats refocus fight against Trump's Supreme Court nominee on healthcare (Reuters)
  • Drug Discounts for Prisoners Crucial for State Budgets (Bloomberg-$)
  • State hits CVS pharmacy benefit company with $1.5 million fine (Courier Journal)
  • FDA expands its support for states to advance implementation of produce safety activities (FDA)
  • Startups Lead a New Rush Into Obamacare's Now-Profitable Markets (Bloomberg)
Upcoming Meetings & Events Europe
  • NICE backs Qarziba for children with high-risk neuroblastoma (PharmaTimes)
  • Gerresheimer to acquire Sensile Medical and its drug-delivery tech (DDBN)
  • Asahi Intecc to buy RetroVascular for $26m (MassDevice)
  • Gopher Completed Guardian ORB System FCC and CE Certification (Press)
  • QIAGEN partners with U.K. to expand biomarker research in Manchester (Press)
  • Philips signs two long-term strategic partnership agreements in Germany (Press)
  • RXB Healthcare Technologies Enters European Market with Acquisition of SPR Global Technologies (Press)
  • Updated: Common issues identified during clinical trial applications (MHRA)
  • Matt Hancock writes in the Health Service Journal about his admiration for the NHS and its staff. (UK Government)
Asia
  • Samsung BioLogics to face criminal probe over accounting fraud for biosims JV (Fierce)
  • iBio and CC-Pharming to develop biosimilar rituximab (The Pharma Letter)
  • A*STAR Institute and Mayo Clinic Identify Key Protein to Convert Skin Cells into Other Types of Cells (BioSpace)
  • CStone's PD-1 inhibitor CS1003 receives clinical trial approval in China (Press)
India
  • Commonly used antibiotic in India under USFDA lens (Times of India)
  • NPPA fixes retail prices of 6 formulations (NPPA)
Australia
  • Montelukast: Safety Review (TGA)
  • TGA presentations: The new Code - where are we at? 12 & 13 June 2018 (TGA)
Canada
  • Thousands of local patients affected by recall of contaminated heart drug (Windsor Star)
  • Protecting Patents in Canada • Common Rule Recommendations (Bloomberg-$)
  • Updated: Application Form for Custom-Made Devices and Medical Devices for Special Access (Health Canada)
  • Notice of intent to amend: Prescription Drug List (PDL): Phytocannabinoids (Health Canada)
General Health & Other Interesting Articles
  • Few U.S. women have serious complications after abortions (Reuters)
  • Everyone deserves a holistic, patient-centric health care system (STAT)
  • How Bundling Care Hurts The Patients Who Need It The Most (Forbes)
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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