Regulatory Recon: FDA Approves Roche's Tecentriq for Advanced Bladder Cancer; Cardinal Health to Buy Medtronic Ops for $6.1B (18 April 2017)

Posted 18 April 2017 By Michael Mezher

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

In Focus: US

  • Roche's Tecentriq wins FDA approval for treating advanced bladder cancer (Reuters) (Pharmafile) (Press)
  • J&J misses sales estimates; lifts forecast to reflect Actelion buy (Reuters)
  • Theranos Agrees Not to Operate Blood Lab for Two Years (WSJ) (Reuters)
  • Cardinal Health's $6.1 Billion Deal for Some Medtronic Operations Raises Debt Concerns (WSJ) (MassDevice) (Medtronic)
  • Draft user fee bill is controversy free (Politico) (Pink Sheet-$)
  • How biopharmaceutical collaborations are fueling biomedical innovation (Deloitte) (PhRMA)
  • Gilead, Pfizer, AbbVie Win From Lilly's Loss (The Street)
  • HHS Secretary Price Authorizes Emergency Use of Nerve Agent Antidotes (Global Defense)
  • Drug and Device Companies Offer Recommendations for FDA's Combo Product Policy Council (Focus)
  • BIO, AdvaMed Seek to Tweak FDA's New Pre-Request Draft Guidance for Combo Products (Focus)
  • Researchers Link Target Product Profiles to Shorter Review Times (Focus)
  • Ramaswamy's Enzyvant scores a double-barreled FDA commitment to help hustle a rare disease drug through its BLA (Endpoints) (Press)
  • Chasing a big payday, new drugmakers slightly favor solo launches: report (Fierce)
  • Kids With Hepatitis C Get New Drugs And Coverage May Prove Easier Than For Adults (KHN)
  • Biosimilar Product Differences Will Affect US Uptake, Amgen Predicts (SCRIP-$)
  • Novartis advances with push on cancer and liver disease (Reuters) (Pharmafile)
  • Novartis Snags Coveted FDA 'Breakthrough' Label for CAR-T, Trial Results Still Under Wraps (The Street) (Fierce) (Press)
  • GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate (Pink Sheet-$)
  • Northwest Bio Receives SEC Subpoena and Other Awful Nuggets From New 10-K (The Street)
  • Nonprofit Working To Block Drug Imports Has Ties To Pharma Lobby (NPR)
  • Court Decisions Force Arkansas to Halt Execution (NYTimes)

In Focus: International

  • The long road to elimination of neglected tropical diseases (Financial Times)
  • More engagement on neglected tropical diseases needed from drugmakers (Financial Times)
  • Dr Margaret Chan: The tide is turning for neglected tropical diseases (Financial Times)
  • UK doubles its aid for neglected tropical diseases (PharmaTimes)
  • Likely Brexit Outcome: Authorized Representatives required on both sides of the new border (Emergo)
  • IMDRF Pushes Harmonized Terminology for Adverse Event Reporting (Emergo)
  • How regulators and NGOs are bringing the threat of fake medicines to light (Pharmafile)
  • Circassia gives up on allergy after house dust mite study fails (Reuters) (PharmaTimes) (Fierce)
  • German Merck aims to role out child formula for schistosomiasis drug (Reuters)
  • State-Owned Pharma Group On Horizon As Korea Eyes Secure Supplies (Pink Sheet-$)
  • Has Article 50 Stymied UK's Role In Unified Patent Court? (Pink Sheet-$)
  • EU expands approval of ALK's house dust mite pill (PharmaTimes)
  • Insight into our Innovation Office (MHRA)
  • Restructuring in the Japanese pharma industry (PharmaLetter-$)
  • Musical chairs for Dr Alexandre Lebeaut at Ipsen (PharmaLetter-$)
  • Pharma can help achieve savings in the other 91% of healthcare spending, says AbbVie's UK boss (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Shire, armed with new rare disease patent, aims to block CSL's Haegarda launch (Fierce)
  • The Drug Innovation Paradox (SSRN)
  • Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose (IPQ)
  • Merrimack names Drummond as head of research unit (Fierce)
  • Missing Genes Point to Possible Drug Targets (NIH)
  • New Plant Gene Network Could Significantly Improve Drug Discovery (GEN)
  • Trial watch: Trends in clinical trial design complexity (Nature)
  • Identifying synergistic drug combinations (Nature)
  • Reversing resistance (Nature)
  • Steroids May Be Risky Even in the Short Term (NYTimes)
  • Fred Hutchinson Team Programs CAR T Cells (BioCentury)
  • Anti-depressant use before, during pregnancy tied to autism risk (Reuters)
  • Novocure gains on additional Optune data (Drug Delivery)
  • Fujifilm Increases Production Capacity and Establishes New Process Development Facilities with JPY14 Billion ($130M USD) Investment to Support Growing Market Demand (Press)
  • Lucentis now FDA-approved to treat all forms of diabetic retinopathy (PharmaLetter-$) (Press)
  • Newron CEO On Xadago & Upcoming Pipeline Milestones (SCRIP-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP (Press) (EPR)
  • Motif Bio antibiotic hits endpoint in skin infection phase 3 (Fierce)
  • FDA confirms Prometic's PBI-4050 IPF clinical trial design (Press)

US: Medical Devices

  • Single Blood Test Rapidly Rules Out MI in Chest Pain (CardioBrief)
  • Is the Price Right for Absorb Scaffold? (Medpage)
  • Drumroll, Please: The 2017 Medtech Startup Showdown Winner Is . . . (MDDI)
  • Monitored Therapeutics, Inc. Receives FDA Clearance for First Full Home-Use Spirometer With Wireless Connection (Press)
  • FDA approves electroCore's treatment for cluster headaches (Nasdaq) (Press)
  • Amendia picks up Spinal Elements (MassDevice)

US: Assorted & Government

  • New Report Highlights Issues with Medicaid Integrity (Senate Finance) (GAO)
  • MD AG Defends First-In-Nation Generic Gouging Bill Amidst Outcry From Generic Industry (IHP-$)
  • The Future Of Investment In PEPFAR: Understanding PEPFAR's Multiple Economic, Health, And Diplomatic Impacts (Health Affairs Blog)
  • High Court Misinterprets Discoveries as Patent Ineligible (Bloomberg)
  • Patent Community Wants Congress to Amend, Clarify Patent Eligibility (Bloomberg)
  • Insurer UnitedHealth posts strong results, boosts forecast (Reuters)
  • How Minnesota Is Stepping Up To Preserve Its Individual Market (Health Affairs Blog)
  • PTAB Life Sciences Report -- Part I (Patent Docs)
  • Widow's Trial Against GSK Wraps With $39M Damages Plea (Law360-$)
  • Abbott Says Consumers Are Twisting Law In Depakote MDL (Law360-$)
  • Eighth Circuit FINALLY Hears Litigation Tourism Issue (Drug & Device Law)
  • Jazz Settles Seven-Year Xyrem Patent Case with Hikma, Granting License for 2023 (FDANews-$)
  • Calif. Says Boehringer Ingelheim Paid Barr $120M For Delay (Law360-$)
  • Drug Co. Investors Seek OK For Early $3.8M Settlement (Law360-$)
  • Dr. Reddy's Defeat Of FCA Case Offers 'Guidepost' For Litigation After Escobar (Pink Sheet-$)
  • NECC Owner Says FDA Fraud Is 'Legal Impossibility' (Law360-$)
  • Miss. Sues Drug Cos. Over Medicaid Reimbursements (Law360-$)
  • Mentally ill accessing less US health care (Reuters)
  • Home-Based Drug Treatment Program Costs Less And Works (NPR)

Upcoming Meetings & Events

Europe

  • UK pharmaceutical industry response to a snap General Election (ABPI)
  • Health Care Inspectorate (IGZ) request to marketing authorisation holders: questionnaire for pharmacovigilance (CBG MEB)
  • WP4 AC-B CA2 on "Repetitive transcranial magnetic stimulation for treatment-resistant major depression" is now available. (EUnetHTA)
  • In Portugal, Drug Use Is Treated As A Medical Issue, Not A Crime (NPR)
  • Committee for medicinal products for human use (CHMP) Minutes of the meeting on 20-23 February 2017 (EMA)

Asia

  • South Korea to downgrade bird flu alert status from highest level (Reuters)
  • Janssen inks deal with Japan's PeptiDream (BioSpectrum)
  • Celgene in Asia-Pacific collab with Antengene, Tigermed as clinical support (Fierce)

India

  • Leprosy: India's hidden plague (Financial Times)
  • Pharma industry waiting for CDSCO's revised post marketing surveillance guidelines (PharmaBiz)
  • TN DC dept takes action against cos, wholesalers for distributing multi-dose vials of diclofenac (PharmaBiz)

Australia

Other International

  • Togo Becomes First Country in Africa to Validate the Elimination of Lymphatic Filariasis as a Public Health Problem (Merck)
  • 'We didn't know we would go blind': fighting onchocerciasis in Ghana (Financial Times)

General Health & Other Interesting Articles

  • How One Medical School Is Dealing With Too Much Information (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? 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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