Regulatory Recon: EU Approves Merck, Pfizer's Bavencio; FDA Advises on Opioid Benzo Combo (21 September 2017)

Posted 21 September 2017 By Michael Mezher

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

In Focus: US

  • Promise and Complexities of a $475 000 Cancer Drug (JAMA) (MIT Technology Review)
  • CRISPR used to peer into human embryos' first days (Nature) (NPR) (Reuters)
  • FDA: Opioid-Benzo Combo OK in Substance Abuse Tx (Medpage) (FDA)
  • 'The Pills Are Everywhere': How the Opioid Crisis Claims Its Youngest Victims (NYTimes)
  • CVS Health Moves to Limit Access to Opioid Painkillers (WSJ-$)
  • Amazon is taking on the drug supply chain, says report (CNBC)
  • FDA OKs BioCryst's Rapivab for Pediatric Indication (The Street) (Press)
  • FDA's Woodcock: The Clinical Trials System is 'Broken' (Focus)
  • Balancing Hatch-Waxman: Stakeholders Weigh in After FDA's Meeting (Focus)
  • FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved (Focus)
  • Sanofi tests three-in-one antibody to treat or prevent HIV (Reuters) (NIH)
  • Graham says US Senate to consider healthcare bill next week (Reuters) (NPR)
  • Cassidy-Graham bill would cut funding to 34 states, new report shows (Washington Post)
  • Insurers Come Out Swinging Against New Republican Health Care Bill (NYTimes)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • Africa to get state-of-art HIV drugs for $75 a year (Reuters)
  • Sanofi threatens to take Ukraine government to arbitration over a court dispute (STAT)
  • Nestle Plans to Ax Hundreds of R&D Staffers, Shutter French Dermatology Campus (Endpoints) (Reuters)
  • EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias (Focus)
  • European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (Focus)
  • EMA Tours Prospective Hosts While Banking Agency Shuns Visits (EU Observer)
  • A Neglected Family Of Killer Viruses (NPR)
  • A China biotech unicorn scores big with $150M-plus IPO on Nasdaq, stock rockets up (Endpoints)
  • EU green light for Merck, Pfizer's Bavencio (PharmaTimes) (Pharmafile) (Reuters) (Press)
  • Merck's MS pill Mavenclad launched in the UK and Ireland (PharmaTimes)
  • Pills prescribed for alcoholism might not work, study finds (The Guardian)
  • Cipla Secures Ex-FDA Official As Compliance Head (SCRIP-$)
  • Brazil Needs Better Orphan Drug Policies, Says Alexion (Pink Sheet-$)
  • China's WuXi, Johnson & Johnson-backed XW Labs lands $17.5M series B (Fierce)
  • Refocused Novo Nordisk Says On 'Road To Recovery' After Traumatic 2016 (SCRIP-$)
  • Apogenix And EMA To Settle On Phase III Plans For PRIME Candidate Asunercept (Pink Sheet-$)
  • Pfizer leads Big Pharma's emerging markets growth as GlaxoSmithKline, Eli Lilly lag (Fierce)
  • ICH Consults On Revised Approaches To Assess Risk Of Reproductive Toxicity Of Drugs (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • A law professor's big idea for combatting greedy drug company titans like Martin Shkreli (Quartz)
  • A Cancer Patient Found a Stem-Cell Donor, but the U.S. Hasn't Granted Her a Visa (NBC)
  • After 20 Years, A Drug That Silences Genes Succeeds (Forbes)
  • After settling with the SEC, biotech VC Steven Burrill now faces up to 30 years for fraud, tax evasion charges (Endpoints)
  • Venturing Boldly Into Neuroscience (Forbes)
  • Glythera taps Iontas for antibodies to guide next-generation ADCs (Fierce)
  • Bone Therapeutics ahead of schedule in delayed fractures (EP Vantage)
  • A Center of Excellence to Secure Medicines Quality Through the Supply Chain (USP)
  • FDA Moves Against Internet Drug Retailers (FDANews-$)
  • With help from J&J, upstart Provention lands rights to two mid-stage IBD drugs and shoots for PhII (Endpoints) (Fierce)
  • More than 85 medicines in development for Alzheimer's disease (PhRMA)
  • Lewis Carroll and the Pricing of Pharmaceuticals (Forbes)
  • Buried in OTC remedies? That's the pitch in Allergan and Ironwood's new Linzess ads (Fierce)
  • Chris Garabedian's Xontogeny shepherds its first biotech through a $10M startup round (Endpoints)
  • Want to start fixing the gender diversity problem in your biotech company? Put down the silver bullet (Endpoints)
  • Cannabidiol attenuates alcohol-induced liver steatosis, metabolic dysregulation, inflammation and neutrophil-mediated injury (Nature)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Amicus Therapeutics says U.S. FDA granted orphan drug designation to ATB200/AT2221 for Pompe disease (Reuters)
  • PhaseRx Receives Orphan Drug Designation from FDA for PRX-ASL for the Treatment of Argininosuccinate Lyase Deficiency (Press)
  • Samsung Bioepis will initiate Phase III trials of a Lucentis biosimilar (Biosimilar News)

Medical Devices

  • Hurricane Maria poses threat to med device hub in Puerto Rico, Medtronic closes facilities (MassDevice)
  • FDA clears first duodenoscope with disposable distal cap (FDA)
  • How small companies can navigate partnerships in medtech (MassDevice)
  • FDA approves Abiomed's Impella RP heart pump (MassDevice)
  • Brainlab announces FDA clearance for two new indication-specific radiosurgery software applications (Press)
  • NaviENT Receives FDA 510(K) Clearance (Press)

US: Assorted & Government

  • CDC issues guidance on storm recovery (Reuters)
  • Death Wish Coffee Recalls Cold Brew Coffee Cans Over Botulism Risk (FDA)
  • Former Lawyer Sues Synthetic Genomics "Boys Club" over Gender Bias (Xconomy)
  • Investors seek class action status in lawsuit over St. Jude implantable defib batteries (MassDevice)
  • FDA Cherry-Picking Record In Sensipar Case, Amgen Says (Law360-$)
  • 4th Bellwether Over J&J Metal Hip Implants Kicks Off (Law360-$)
  • Patent For Cholesterol Drug Livalo Is Valid, Judge Rules (Law360-$)
  • Fifth Circuit Upholds Summary Judgement for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case (FDA Law Blog)
  • Bah to Legal Lambs (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • World Alzheimer's Day: could we create a world without dementia? (MHRA)
  • MHRA statement on Essure devices (MHRA)
  • UK warns about alarm failure for Roche's insulin pumps (Drug Delivery) (MassDevice)
  • EMA Updates 18-Year-Old Guidelines for Cardiovascular Clinical Trials (FDANews-$)
  • Recipharm Acquires Roche Spain Facility, Saves 200 Jobs (Pharmaceutical Manufacturing)
  • Endologix Announces CE Mark Approval for the Nellix EndoVascular Aneurysm Sealing System with the Refined Indications for Use (Press)

Asia

  • Arcus' cancer portfolio attracts $35M option deal from Japan's Taiho (Fierce)

India

  • Delhi HC asks entities of Religare promoters for timeline of health insurance business sale (Economic Times)
  • NPPA slashes prices of medicines for TB, cancer, hepatitis B by up to 20% (Economic Times)
  • Zydus Pharma recalls 44.8 K bottles of antidepressant in US (Economic Times)
  • Dr Reddy's gets EIR for 2 facilities (Economic Times)
  • Orchid Pharma gets EIR from USFDA for its Alathur facility (Economic Times)
  • DoP asks NPPA to re-fix ceiling price of Co-Trimoxazole tablet after examining documentary proof submitted by Cadila Healthcare (PharmaBiz)

Canada

  • Notice - Patented Medicines (Notice of Compliance) Regulations (Health Canada)
  • Guidance Document - Certificate of Supplementary Protection Regulations (Health Canada)
  • How to Pay Fees to Health Products and Food Branch (HPFB) (Health Canada)

General Health & Other Interesting Articles

  • Dr. Edmond Eger II, 86, Dies; Found Way to Make Anesthesia Safer (NYTimes)
  • Tuberculosis Elimination in the United States — The Need for Renewed Action (NEJM)
  • Egg freezing may not delay chemo for breast cancer patients (Reuters)

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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