Regulatory Focus™ > News Articles > Regulatory Recon: Mitsubishi Tanabe Buys NeruoDerm for $1.1B; FDA Reviewers Raise Concerns About Int

Regulatory Recon: Mitsubishi Tanabe Buys NeruoDerm for $1.1B FDA Reviewers Raise Concerns About Intelli's Long-Acting Opioid Ahead of Panel (24 July 2017)

Posted 24 July 2017 | By Michael Mezher 

Regulatory Recon: Mitsubishi Tanabe Buys NeruoDerm for $1.1B FDA Reviewers Raise Concerns About Intelli's Long-Acting Opioid Ahead of Panel (24 July 2017)

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

In Focus: US

  • Trump's FDA Chief Takes Wide Aim at Opioid Addiction Crisis (Bloomberg)
  • FDA staff raise concerns about Intellipharma's opioid painkiller (Reuters)
  • The unnecessary risk with over-the-counter drugs (Politico)
  • Drug spending in U.S. tops the world. Translation: No pricing-headache relief soon (Fierce)
  • Democrats take aim at big business and drug prices in new economic campaign (CNBC) (STAT) (CNN)
  • The drug industry is lobbying the federal government at a record-setting pace so far this year (STAT) (KHN)
  • Companies Rush to Develop 'Utterly Transformative' Gene Therapies (NYTimes)
  • President Trump to deliver statement on health care on Monday (CNBC)
  • Senate Republicans plan to plow ahead with health-care vote this week (Washington Post) (Reuters)
  • Republicans' push to roll back Obamacare faces crucial test (Reuters) (Politico)
  • Eli Lilly offers $400M-plus deal to bag an early-stage autoimmune drug from Nektar (Endpoints) (Fierce) (EPVantage) (Press)
  • Gilead details its case for a new HIV flagship triple, with megablockbuster potential (Endpoints) (STAT) (Press)
  • 'Mosaic' HIV vaccine from J&J and partners passes early test (Fierce) (NIH)
  • A new wave of pharma mergers could put innovative drugs in the pipeline (STAT)
  • Samsung Bioepis launches U.S. sales of Remicade biosmiliar (Reuters) (Press)
  • FDA Approves Subcutaneous Benlysta Formulation (BioCentury) (Press)
  • FTC approves Baxter's $625m Claris buyout, with conditions (Drug Delivery)
  • Sarepta files $250M fundraising, says it's considering more bolt-on deals (Fierce)
  • All Backed Up: FDA Reverses Course and Denies NCE Exclusivity for PREPOPIK (FDA Law Blog)
  • Leadership and strategic innovation in pharma (McKinsey)

In Focus: International

  • Mitsubishi Tanabe bags NeuroDerm and its PhIII Parkinson's program for $1.1B (Endpoints) (Pharmafile) (Financial Times)
  • Bayer says asbestos-related tumor treatment misses key goal (Reuters) (Fierce)
  • EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda (Focus)
  • Troubled Teva brings out the ax as it cuts deep into its Israeli pharma group (Endpoints) (Pharmafile)
  • GSK chief plans to shake up culture and competitiveness (Financial Times)
  • Pay for medicines based on effectiveness, NHS told (Financial Times) (PharmaTimes)
  • NHS England takes tough stance on homeopathy (Pharmafile)
  • Merck, Pfizer's avelumab clears first hurdle in early access scheme (PharmaTimes)
  • Chinese Regulators Identify First Round of Medical Device Clinical Trial Inspections (Emergo)
  • GSK files for extended use of Relvar Ellipta in asthma (PharmaTimes)
  • UK bioscience companies form Rare Disease Industry Group (EPR)
  • UK Court Shakes Up Test For Equivalent Infringement In Lilly/Actavis Case (Pink Sheet-$) (Patent Docs)
  • Brazil Makes Drug Prices Transparent To Strengthen Hand In Pricing Talks (Pink Sheet-$)
  • HIV and cancer teams double up to seek out new disease killers (Reuters)
  • Hopes for HIV cure revived by African child in remission (Reuters) (NIH)

Pharmaceuticals & Biotechnology

  • A toolbox for creating new drugs (PhysOrg)
  • Aeterna CEO Dodd out as company reviews options (Fierce)
  • Could CAR-T treatments work in glioblastoma? (Fierce)
  • Clinical trials for cancer could use more older people (Washington Post)
  • Helix Bets An 'App Store' Can Make Consumers Care About Their DNA (Forbes) (MIT Technology Review)
  • Another micro-cap biotech has flunked a pivotal test for a regenerative cell therapy (Endpoints)
  • Beyond The Nasty Needle: Trying To Make Vaccines More Comfy And Convenient (NPR)
  • Drug interaction concerns may negatively affect HIV treatment adherence among transgender women (NIH)
  • With Viagra and Lyrica fading, analysts downgrade Pfizer due to mounting challenges (Fierce)
  • Backed by partners at Pfizer, eFFECTOR brings its VC total to $150M as PhII cancer trial looms (Endpoints)
  • The HPV Vaccine Saves Lives, So Why Aren't More Kids Getting It? (Forbes)
  • Stem Cell Clinics Are Advertising Their Treatments As Clinical Trials. They're Not (Forbes)
  • Heart attack patients missing out on smoking cessation drugs (Reuters)
  • German pharma major to invest $217 million in US manufacturing site expansion (PharmaLetter-$)
  • Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? (BMC Medicine)
  • Endo shutters manufacturing facilities in Huntsville (Drug Delivery) (PharmaLetter-$)
  • What Should FDA Pilot? (RxTrace)
  • FDA eyes 'toolkit' to combat fake meds in supply chain (Securing Industry)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B7391003 Study for PF-06439535, a Potential Biosimilar to Avastin®1 (bevacizumab) (Press)
  • UCB Psoriasis Candidate Headed For PHASE III (BioCentury)
  • Aerie touts late-stage safety data for Roclatan eye drops (Drug Delivery)
  • U.S. Food and Drug Administration Expands Approval of Yervoy® (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma (Press)
  • CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) (Press)
  • Samumed Successfully Completes Phase I Study for Potential Topical Treatment for Chronic Tendinopathy (Press)
  • BlackThorn Therapeutics Enrolls First Patient in Phase 2a Study of Lead Compound, BTRX-246040, in Major Depressive Disorder (Press)
  • Novocure™ Announces a Phase 1b Clinical Trial to Evaluate the Safety of Marizomib and Temozolomide in Combination with Optune® as Adjuvant Therapy in Patients with Glioblastoma (Press)

Medical Devices

  • The Secret to Developing a Commercially Successful Point-of-Care Device (MDDI)
  • Could this temperature sensor reduce power consumption in medical devices? (Medical Design & Outsourcing)
  • FDA clears updated labeling, design for FujiFilm ED-530XT duodenoscopes (MassDevice) (FDA)
  • A bevy of digital health FDA clearances mark a busy second quarter in 2017 (MobiHealthNews)
  • FDA recalls Penumbra 3D Revascularization device over wire separation issues (MassDevice) (FDA)
  • CompuFlo Epidural Anesthesia System Measures Pressure at Needle's Tip, Cleared by FDA (medGadget)
  • Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay (Press)
  • Arrow® Seldinger Arterial Catheterization Device Receives FDA Market Clearance (Press)
  • Milestone Scientific's new FDA-cleared epidural instrument senses pressure (MobiHealthNews)
  • DarioHealth wins FDA nod for Android diabetes app (MassDevice)

US: Assorted & Government

  • Lawyers Hope to Do to Opioid Makers What They Did to Big Tobacco (WSJ)
  • Martin Shkreli fraud trial could go to jury next week; judge slams lawyers for arguing 'like two little children' (CNBC)
  • Ohio places drug pricing measure on its November ballot (STAT)
  • U.S. jury sides with Amphastar over Momenta in drug patent trial (Reuters)
  • Illumina, Qiagen Settle DNA Sequencer Patent Dispute (law360-$)
  • Artificial Intelligence and Learned Intermediaries (Drug & Device Law)
  • Merck's Zostavax draws new litigation from patients alleging they contracted shingles (Fierce)

Upcoming Meetings & Events

Europe

  • EMA Recommends Suspending Certain Gadolinium Contrast Agents (Focus)
  • UK's Boots 'truly sorry' over morning-after pill campaign response (Reuters)
  • Industry unites to stop falsified medicines in Hungary (PharmaLetter-$)
  • More people will be able to give blood following scientific review (UK DoH)

Asia

  • H1N1 virus infects 13 in Myanmar, suspected of killing one (Reuters)
  • China Drug Inspections, 2016 (FDAZilla)
  • Hemophilia A candidate emicizumab filed for approval in Japan (PharmaLetter-$)

India

  • Lupin receives US FDA approval for anti-inflammatory topical solution (Economic Times)
  • Strides Shasun gets USFDA nod for anti-allergy capsules (Economic Times)
  • Anti-Dumping Duty Likely On A Chinese Import Used By Indian Pharma Companies (Bloomberg)
  • Kinfra to set up pharma park in Kochi under MSE-CDP to boost pharma production in Kerala (PharmaBiz)

Canada

  • Sunovion's Latuda® (lurasidone HCI) Receives Health Canada Approval to Treat Adolescents with Schizophrenia (Press)

General Health & Other Interesting Articles

  • Lesser-known gene mutations may boost breast cancer risk in Jewish women (Reuters)
  • She lost her sight to a rare condition — and became a medical detective (Washington Post)

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.


Categories: Recon, Regulatory News

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