rf-fullcolor.png

 

November 20, 2018
by Michael Mezher

Recon: Boston Scientific to Buy BTG for £3.3B; MHRA Head Hudson to Step Down in 2019

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • PhRMA funnels millions to addiction group with close ties (Politico)
  • Sanders unveils aggressive new bill targeting drug prices (The Hill)
  • As power shifts hands in Washington, a top analyst predicts an unavoidable war over rising drug prices (Endpoints)
  • Consumer group says most US cancer centers use misleading ads (NBC)
  • US court allows generic version of Indivior opioid abuse drug (Reuters)
  • FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease (FDA) (Press)
  • Pharma companies put faith in AI for breakthroughs (Financial Times)
  • Trial spotlights US drug safety concerns at compounding pharmacies (Reuters) (MassDevice) (Law360-$)
  • Opioid Industry Fights Efforts to Make It Pay for Crisis (WSJ)
  • LEO Pharma inks $760M rare skin disease R&D deal with PellePharm (Fierce) (Endpoints)
  • Roivant takes aim at resistant infections with $667.5M Intron deal (Fierce)
  • Student borrowers with cancer can now pause their payments (CNBC)
  • Palantir and Merck KGaA form venture to mine health care data (STAT) (Endpoints)
  • FDA opts to nail down REMS plan for Sage’s landmark postpartum depression drug, delays final decision (Endpoints)
In Focus: International
  • Boston Scientific to buy rattlesnake bite drug group BTG for £3.3bn (Financial Times) (PMLive)
  • UK medicines agency head to step down in 2019, as Brexit looms (Reuters)
  • Emergent-Valneva Zika vaccine clears early trial (Reuters)
  • EU’s Innovative Medicines Initiative brings collaborative power to development of drugs (Financial Times)
  • Big pharma 'failing to develop urgent drugs for poorest countries' (The Guardian) (Reuters) (Endpoints) (Report)
  • India High Court quashes Abbott’s plea to stall CCI probe into alleged cartelization (Economic Times)
  • Major proxy firms advise investors to approve Shire-Takeda deal (Financial Times) (Endpoints)
  • French Launch Fast-Track Clinical Trial Approval Scheme (Pink Sheet-$)
  • Eli Lilly's Emgality cleared for treatment of migraine in Europe (Pharmafile)
  • Greece eyes pot of gold as medicinal cannabis licensed (Reuters)
Pharmaceuticals & Biotechnology
  • Enlivex to merge with BioBlast, bagging Nasdaq listing (Fierce) (Endpoints)
  • FDA extends decision date for Sage’s postpartum depression injection (Drug Delivery)
  • Will We Ever Cure Alzheimer’s? (NYTimes)
  • Is Amarin’s Fish-Oil-Derived Drug A Historic Breakthrough Or Not? It’s Complicated (Forbes)
  • Lilly's Robert Brown to lead Brickell Bio as it eyes phase 3 dermatology trials (Fierce)
  • New Report Shows Global Link Between Pro-Innovation Policies and Biotech Advances (BIO)
  • Scientists are trying to create a contraceptive that stops sperm in its tracks (STAT)
  • FDA Reports Growing Use Of Process Modeling Tools To Support Continuous Manufacturing (Pink Sheet-$)
  • Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later (Pink Sheet-$)
  • US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids (Pink Sheet-$)
  • Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • GSK files Nucala for wider paediatric use (PharmaTimes)
  • Stallergenes Greer’s dust mite allergy drug clears pivotal study, edges closer to approval (Endpoints) (Press)
  • Ipsen and 3BP announce First Patient Dosed in Phase I/II study for first-in-class radionuclide (IPN01087) (Press)
  • Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ® (ceftazidime and avibactam) (Press)
Medical Devices
  • Medtronic’s Q2 results top estimates despite profit slide (MassDevice) (Press)
  • Mazor Robotics shareholders OK $1.6B Medtronic merger (MassDevice)
  • Is Your 510(k) Device a Combination Product? (FDA Law Blog)
  • Philips wins CE Mark for V60 Plus high flow ventilator (MassDevice)
  • Abbott Nabs Approvals for DRG Invisible Trial System (MDDI)
  • Avenu Medical wins CMS reimbursement for Ellipsys dialysis device (MassDevice)
  • RTI Surgical wins coverage nod for Simmetry implant (MassDevice)
US: Assorted & Government
  • House Democrats target DOJ decision not to defend Obamacare (Reuters)
  • Florida's opioid lawsuit against CVS and Walgreens takes aim at distributors with deep pockets (CNBC)
  • CVS now expects Aetna acquisition to close after Thanksgiving (CNBC)
  • The health care venture from Amazon, Berkshire and JP Morgan just hired its first female exec, and she comes from a big insurance company (CNBC)
  • Free Mallinckrodt Drugs Risk Kickback Fines, Watchdog Says (Law360-$)
  • Delivery dilemma for medical marijuana (Financial Times)
  • FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018) (Patent Docs)
  • Another Nationwide Class Action Bites the Dust Under BMS (Drug & Device Law)
Upcoming Meetings & Events Asia
  • China’s Alphamab raises $100M in Series A financing from US, Asian investors (MedCity)
  • Roche and Ascletis partner to sell Pegasys in China (PharmaLetter-$)
  • China’s NMPA approves Vemlidy for chronic hepatitis B (PharmaLetter-$)
  • Invivoscribe Submits FLT3 Mutation Assay CDx to Japanese Regulators (GenomeWeb)
India
  • Health Ministry's move to revise GMP norms could be delayed as stakeholders yet to submit response (PharmaBiz)
Australia
  • Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration (TGA)
General Health & Other Interesting Articles
  • A Prescription For What Costs $117 Billion A Year And 10 Percent Of Premature Deaths In America (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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.