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Recon: Catalent to Buy Juniper Pharmaceuticals for $128m

Posted 03 July 2018 | By Ana Mulero 

Recon: Catalent to Buy Juniper Pharmaceuticals for $128m

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

In Focus: US
  • Sanofi beefing up diabetes pipeline, sees growth returning (Reuters)
  • When Should Pharma Execs Actually Care About AI? (Forbes)
  • Evaluating human trials: FDA's role (Science)
  • Why July Is a Risky Month for Drug Price Backlash (WSJ) (Axios)
  • Why Amazon’s Push Into Prescription Drugs Isn’t a Guaranteed Success (NYT) ((Axios)
In Focus: International Pharmaceuticals & Biotechnology
  • How Sensitive Is Pfizer To R&D Expense Changes? (Forbes)
  • When analysts say sell, it’s time to buy – at least in biotech, new report shows (CNBC)
  • Is Martin Shkreli blogging from prison? (Endpoints) (Fierce)
  • Big biopharma not the best investment so far in 2018 (EP Vantage)
  • Regeneron, Sanofi show restraint on Dupixent price hike, but Pfizer’s hard charge continues to spur calls for a radical change-up (Endpoints)
  • A Look at Hemophilia Drug Prices and the Market (BioSpace)
  • Artificial Organs for Biopharma Research and More (BioSpace)
  • Alcon spin-off prompts Novartis downgrade by Moody’s (PMLiVE)
  • People with allergies often leave life-saving epinephrine at home (Reuters)
  • Doctors prescribing new migraine breakthrough at University of Kansas Health System (KCTV)
  • Minnesota sues OxyContin maker, alleging sales tactics fueled overdoses (Minneapolis Star Tribune)
  • Companies are racing to develop fast-acting depression drugs — but the process is tricky (STAT-$)
  • Drug Cos. In Opioid MDL Must Divulge Vast Data Trove (Law360-$)
  • CVS Wants Antitrust Suit Over 340B Drug Program Tossed (Law360-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Compugen Advancing Cancer Immunotherapies to Clinical Trials (GEN)
  • Cash-strapped Titan delays Parkinson’s implant program (Fierce)
  • FDA OK's 1-Day Initiation for Long-Acting Injectable Schizophrenia Tx (MedPage Today)
  • Antibe Therapeutics Releases Secondary Endpoint Data from Recent Phase 2B Gastrointestinal Safety Study for Lead Drug, ATB-346 (Press)
  • Eagle Pharmaceuticals Announces New Patent Issued for BENDEKA (Press)
  • Abivax Releases Positive Top Line Data from ABX464-005 Phase 2a Study in HIV Infection (Press)
Medical Devices
  • Creo aims to raise more funds to support U.S. endosurgery rollout (Fierce)
  • Sepsis is the third leading cause of death. Can a new blood test change that? (STAT)
  • Integer sells advanced surgical, ortho lines to MedPlast (MassDevice)
  • Medtronic takes on risk in payer and employer contracts tied to insulin pump use (MedCity News)
  • Mercy shares EHR data with Johnson & Johnson to help improve its medical devices (Healthcare IT News)
  • Lexion Gets SurgiQuest 'Tube' Patent Axed By PTAB (Law360-$)
  • Abbott Must Look Again For Docs Sought By Alere Investors (Law360-$)
US: Assorted & Government
  • CMS proposes paying home health agencies for remote monitoring (Modern Healthcare) (Health Data Management) (Inside Health Policy-$) (Fierce)
  • No, Massachusetts, you can't run a PBM-style Medicaid formulary, Feds say (Fierce)
  • Finally, Some Answers on the Effects of Medicaid Expansion (NYT)
  • What Are the Rules for Ethical Medication of Migrant Kids? (The Hastings Center)
  • UTrump administration names new U.S. drug enforcement chief (Reuters)
  • How disparate EHR systems, lack of interoperability contribute to physician stress, burnout (Healthcare IT News)
  • Amazon May Push Walgreens To Expand UnitedHealth And LabCorp Deals (Forbes)
  • Amazon could start selling discounted meds to cash payers as soon as the PillPack deal closes (CNBC)
  • Virtual doctor start-up American Well is raising over $300 million and Philips is a new investor (CNBC)
  • MQSA National Statistics (FDA)
Upcoming Meetings & Events Europe
  • Pfizer Can Use German IP Rights to Block Certain EU Imports (Bloomberg)
  • EU green light for Cimzia to treat psoriasis (PharmaTimes)
  • NICE says Tookad too expensive for prostate cancer (PharmaTimes)
  • Scientists Say They've Made Progress on an Artificial Ovary to Help Cancer Patients. There's a Catch (Fortune)
  • Biological Switch May Offer Better Control of Gene Editing (GEN)
  • New database for medical device, IVD registrations in Spain to become fully operational on 5 July (AEMPS)
  • GDPR behind drop in pharma payment disclosure, says ABPI (PharmaTimes) (ABPI)
  • ABPI blames doctor payment disclosure dip on GDPR (PMLiVE)
  • Pharma body calls for more State funding on medicines (Irish Times)
  • EFPIA President: Next EU Commission should prioritise competitiveness in pharma innovation (EURACTIV)
  • Liquid Biopsy Test for Liver Cancer Detection to obtain CE Mark (Press)
  • May 2018: Advertisement of Chloramphenicol capsules 250mg, a prescription only medicine to the public (MHRA)
  • Update: MHRA: business impact target (MHRA)
  • Hong Kong exchange picks up steam with two biotech IPOs from Innovent, MicuRx (Endpoints)
  • Wells Bio’s Zika diagnostic kit receives WHO approval (Korea Biomedical Review)
  • Siemens, AMC develop novel cardiac CT imaging technique for children (Korea Biomedical Review)
  • Shut Chinese companies hit desi pharma players (Times of India)
  • Fullerton, Microsoft Singapore to drive digital transformation (BioSpectrum)
  • Singapore institutes collaborate with ROK to develop innovative drugs (BioSpectrum)
  • Gujarat FDCA notifies 145 MD officers for audits, 30 state licensing officers for grant of medical device licenses (Pharmabiz)
  • PMO Keen on Regulating Oxytocin, a Hormone Misused on Cattle (The Wire) (Pharmabiz)
  • Govt to rope in project consultant to implement new pharma cluster development scheme on PPP basis (Pharmabiz)
  • Secret pacemaker payments boosting private hospital coffers but costing the health system (ABC News)
  • New hub to boost life sciences and innovation research (The University of Western Australia)
  • Gore Announces First Commercial In-Human Use of GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System for TEVAR in Australia (Press)
  • Insulet’s Omnipod nabs preferred insulin pump status in British Columbia (DDBN)
  • Health Canada gives clearance to WAT Medical's innovative devices (BioSpectrum)
General Health & Other Interesting Articles
  • High blood pressure in pregnancy tied to heart disease risk afterward (Reuters)
  • Autism Genetic Complexity Comes to Light (GEN)
  • 5G: Not Just the ‘Next G’ for Connected Health (The App Association)
  • Fentanyl Is Causing Almost Half of All Overdose Deaths, Research Shows (Fortune)
  • Emergency departments: the ‘chewing gum and duct tape’ holding together U.S. health care (STAT)
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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