Regulatory Focus™ > News Articles > Regulatory Recon: Roche Buys Cancer Specialist Ignyta for $1.7B; FDA Approves La Jolla's Low Blood P

Regulatory Recon: Roche Buys Cancer Specialist Ignyta for $1.7B FDA Approves La Jolla's Low Blood Pressure Drug (22 December 2017)

Posted 22 December 2017 | By Michael Mezher 

Regulatory Recon: Roche Buys Cancer Specialist Ignyta for $1.7B FDA Approves La Jolla's Low Blood Pressure Drug (22 December 2017)

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

In Focus: US

  • FDA approves La Jolla's low blood pressure drug (Reuters) (FDA)
  • Roche snaps up Ignyta and its experimental lung cancer drug for $1.7 billion (STAT) (Reuters) (Endpoints) (Financial Times) (Press)
  • New Drug Approvals for FDA: 2017 Hits 21-Year High (Focus) (STAT)
  • FDA Chief Says He's Open To Rethinking Incentives On Orphan Drugs (NPR)
  • 2.3% Tax on Medical Device Companies to Take Effect in 2018 (Focus)
  • CMC Changes for Biologics: FDA Offers Draft Guidance (Focus)
  • Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health (Focus)
  • Sen. Grassley Questions Gottlieb Over Crackdown on Prescription Drug Importation From Canada (Letter)
  • 'I Am Going to Die Without This': Regulators Target a Health-Care Lifesaver (Bloomberg)
  • New Genome Scores Predict Breast Cancer Odds for Any Woman (MIT Technology Review)
  • Biosimilars, Biologics And New Legal Challenges For RA Treatments (KHN)
  • Federal Circuit Issues Mandate In Amgen V. Apotex (Big Molecule Watch)
  • The evolving paradigm of cancer trials (Nature)
  • Janssen buys into Legend's CART therapy (PharmaTimes) (Endpoints)
  • North Carolina accuses drugmaker Insys of scheme to push opioid (Reuters)
  • Report Card For 2017: My Crystal Ball Predictions For Biotech (LifeSciVC)
  • Purdue, maker of OxyContin, launches major ad campaign to counter critics (STAT)
  • Deal struck to mine cancer patient database for new treatment insights (STAT)
  • FDA rejects Agile's contraception patch for second time (Endpoints) (Reuters)

In Focus: International

  • UK Industry Body Says NICE Appraisal Changes Don't Go Far Enough (Pink Sheet-$)
  • NICE rejects Roche's Tecentriq for pre-treated urothelial cancer (PharmaTimes)
  • AZ and ICL link to research respiratory diseases (PharmaTimes)
  • KindredBio Submits Mirataz to EMA (Reuters)
  • European Regulatory Roundup: Roche Escapes Penalty for Breaching EU Pharmacovigilance Rules (Focus)
  • Make, break or fudge: How 2018 will redefine the European regulatory landscape (Fierce)
  • 10 Predictions For A Global Healthcare Market Set To Cross The $1.85 Trillion Mark In 2018 (Forbes)
  • Clover Biopharmaceuticals Gets CFDA Approval to Start Clinical Trials of  its Enbrel Biosimilar Candidate (Press)

Pharmaceuticals & Biotechnology

  • Seven pharma trends for 2018 (Pharmafile)
  • Pioneering cancer therapy makes two CAR-T drugs the approvals of the year (STAT)
  • A dynamic map for learning, communicating, navigating and improving therapeutic development (Nature)
  • Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease (Nature)
  • 5 Milestones Of 2017 In The War On Cancer (Forbes)
  • Adopting a creative IP approach towards biotech clusters (PMLive)
  • FDA Pulls Boxed Warnings on Asthma Risks on Some Inhalers (Focus)
  • Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice (Pink Sheet-$)
  • Notes from the Field: Use of Asynchronous Video Directly Observed Therapy for Treatment of Tuberculosis and Latent Tuberculosis Infection in a Long-Term–Care Facility ― Puerto Rico, 2016–2017 (CDC)
  • Pink slips in one hand, crossed-out pipelines in the other: How 2017's new brooms cleaned house (Fierce)
  • Biotech IPOs roared back in 2017, but what will the next year bring? (Fierce)
  • Following cancer combo deal with Bristol-Myers, Taris gets $25M Series B (Endpoints)
  • Compounders Who Skirt The FDA: Who Is The Expert Here? (National Law Review)
  • Synergy CEO passes torch to CCO Troy Hamilton; President Steven Kafka resigns from Foundation; AbbVie vet John Leonard to helm Intellia (Endpoints)
  • Replacing prescription drugs while traveling overseas is a beast. Here's some advice (STAT)
  • HPV vaccine doesn't lead to unsafe sex (Reuters)
  • Nanomaterials In Drugs To Get Risk-Based Oversight (Pink Sheet-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Novartis combo therapy for melanoma gets FDA priority review (Reuters) (Press)
  • New Oral Ertugliflozin For T2D Approved by FDA (Medpage)
  • Ra Pharmaceuticals Initiates Dosing in Phase 2 Clinical Trial Evaluating RA101495 SC in Generalized Myasthenia Gravis Patients (Press)
  • J&J'S Apalutamide Gets Priority Review For CRPC (BioCentury)
  • FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes (Press)
  • Celgene shares sink after another PhIII lymphoma flop and J&J steps up for the late-stage BCMA race (Endpoints) (Press)
  • Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV (Press)

Medical Devices

  • What is the future of medtech in 2018? (Medical Design & Outsourcing)
  • The Latest FDA Move To Limit Digital Health Software Regs (Law360-$)
  • Carefusion wins $50m Pentagon contract (MassDevice)
  • The potential impact of FDA's use of PRO to assess effects of medical devices (MedCityNews)
  • Report: Apple is working on an in-house Apple Watch ECG to compete with AliveCor's Kardiaband (MassDevice)
  • Medtech Firms Unite to Give OEMs a Hand Up (MDDI)
  • Procept BioRobotics wins de novo nod from FDA for Aquabeam prostate treatment (Robot Report)
  • Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia® 2 Instrument for Use with Sofia Strep A+ Assay (Press)
  • Avinger bids for FDA nod for new Pantheris atherectomy device (MassDevice)
  • QView Medical Inc. Announces FDA PMA Approval for QVCAD™ for the GE Invenia™ 3D Automated Breast Ultrasound System ("ABUS") (Press)
  • Gynesonics submits 510(k) premarket notification for uterine fibroid treatment (MassDevice)

US: Assorted & Government

  • Obamacare enrollment down only slightly after late surge in demand (Reuters)
  • The Opioid Crisis Comes to the Workplace (The Atlantic)
  • Attorney General Sessions Announces Director of Opioid Enforcement and Prevention Efforts (DoJ)
  • Leech Lake Band of Ojibwe sues drug companies over opioids (Pioneer Press)
  • Boston-area paramedics on front lines of US opioid crisis (Reuters)
  • Second US judge blocks Trump administration birth control rules (Reuters)
  • HHS Regulatory Agenda Omits Drug Pricing Actions – Unless OTC Switches Still Count (Pink Sheet-$)
  • Appeals court denies stent pioneer Jang another run at Boston Scientific (MassDevice)

Upcoming Meetings & Events

Asia

  • Number of births in Japan to hit record low in 2017 (Reuters)

India

  • Domestic firms volunteer to drop syringe, needle prices over 50% (Economic Times)
  • Maharashtra FDA detects 205 NSQ drugs through routine inspections across state (PharmaBiz)

Canada

  • Notice - Amendments to the Food and Drug Regulations for Mica (Health Canada)

Other International

  • Summit Therapeutics out-licenses ridinilazole for Latin America (PharmaLetter-$)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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