Regulatory Recon: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals; FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017)

Posted 09 November 2017 By Michael Mezher

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

In Focus: US

  • Trump says he and China's Xi to try to end opioid crisis (Reuters)
  • Despite Trump's Pleas, China's Online Opioid Bazaar Is Booming (NYTimes)
  • The White House punted to Congress on opioids funding. Congress doesn't have a plan (STAT)
  • FDA OKs Merck drug that prevents infection post-stem cell transplant (Reuters) (Press) (Endpoints)
  • Sage Therapeutics shares soar after postpartum depression drug meets main goal (Reuters) (STAT) (Endpoints)
  • FDA Accepts Otsuka's Resubmission of Tolvaptan (Press)
  • Ex-pharma exec Azar is top choice to run US health agency: Sources (Reuters) (Bloomberg)
  • The Medicines Company PCSK9 Inhibitor Strategy: More Heart Patients Via Lower Pricing (Forbes)
  • FDA Awards Funding to Support Pediatric Clinical Trials Research (FDA Voice)
  •  The FDA Is Open To Medical Marijuana For Vets, But Other Agencies Stand In The Way (Forbes)
  • Maine governor says he will not expand Medicaid despite vote (Reuters)
  • Repeal of individual mandate would increase uninsured, premiums: CBO (Reuters)
  • Under Trump, Biologists Seek a Low Profile for Controversial Research (MIT Technology Review)
  • Congress Weighs Repeal of Tax Credit for Rare Disease Drugs (NYTimes)
  • Shopping for Prescriptions: How Deductibles Will Reshape the Pharmacy Industry (Drug Channels)

In Focus: International

  • AstraZeneca rides China wave as rival GlaxoSmithKline struggles (Reuters) (Financial Times)
  • Sanofi pays $40M, commits $765M more for preclinical MS drug (Fierce) (Endpoints)
  • EFPIA member survey on the implications of Brexit on medicines supply (EFPIA) (ABPI) (PharmaTimes)
  • Thousands of drugs face Brexit risk, makers to duplicate testing (Reuters)
  • Relocation of the UK-based EU agencies - Frequently asked questions (EU Council)
  • The notified body conundrum (MedicalDevicesLegal)
  • MRC spin out Bicycle Therapeutics announces partnership with AstraZeneca in £1bn deal (MRC)
  • Gene-Therapy Grafts Have Repaired a Child's Devastating Skin Disorder (MIT Technology Review) (NPR) (NYTimes) (Nature)
  • EU CHMP To Review July Rejection Of Drugs For Schizophrenia, Metastatic Breast Cancer (Pink Sheet-$)
  • Hikma cuts forecasts, key new drug hits fresh FDA barrier (Financial Times 1, 2) (Reuters)
  • Merck KGaA has contacted prospective buyers of consumer health (Reuters)
  • Germany's Merck posts flat 3rd-qtr sales and earnings decline (PharmaLetter-$)
  • BMS adds another EU indication to Opdivo's growing list (PMLive)
  • NHS England seals access deals with big pharma for breast cancer and MS (Pharmafile) (EPR)
  • NICE brings on board Sigma to boost med tech uptake (PharmaTimes)
  • Novartis ties with Royal Marsden to boost cancer care (PharmaTimes)
  • Pakistan shuts down last MSF facility in tribal areas (Reuters)
  • Hearing aid maker William Demant trusts in hearing quality, not smart features (Reuters)
  • Russia Floats Conditions To Approve Bayer-Monsanto Deal (Law360-$)

Pharmaceuticals & Biotechnology

  • Alternatives to Opioids for Pain Relief (NYTimes)
  • Walid Gellad: A Unique Voice in the Drug Pricing Debate (GEN)
  • New report and event examine the new era of vaccines (PhRMA)
  • Adjuvant Melanoma Therapy — Head-Spinning Progress (NEJM)
  • Anthem Sets Conditions for Covering Exondys 51 (Anthem)
  • EPA Approval Of Bacteria To Fight Mosquitoes Caps Long Quest (NPR)
  • Creative Minds: Building a CRISPR Gene Drive Against Malaria (NIH)
  • Selecta feels the pain of gout (EP Vantage)
  • Ex-Shire exec Phil Vickers joins the migration to startups, taking the reins at an immuno-oncology biotech (Endpoints)
  • Pre-Submission Facility Correspondence Session at AAM Fall Tech Strikes a Nerve (Lachman Consultants)
  • One in six facilities fail to pay FDA's user fees — is the US generic supply chain at risk? (PharmaCompass)
  • Otonomy's renaissance starts as Ménière's disease drug clears trial (Fierce) (Press)
  • Improving cancer immunotherapy by harnessing new technology (Fierce)
  • Cambrex's small scale API expansion open in Iowa, US (InPharma)
  • Chasing Alexion, Apellis hits the start button for $150M IPO (Fierce)
  • Novartis strengthens autoimmune indications for Cosentyx (PMLive)
  • Keryx looks to boost 'disappointing' Auryxia with new iron deficiency launch (Fierce)
  • After asthma success, AstraZeneca and Amgen's tezepelumab misses in atopic dermatitis (Fierce)
  • Editas-backer Partners taps Lilly to help raise $171M fund (Fierce)
  • IRB consolidation continues as Chesapeake and Schulman merge to form Advarra (OutsourcingPharma)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Bristol-Myers Squibb and Five Prime Present Phase 1a/1b Data Evaluating Cabiralizumab (anti-CSF-1 receptor antibody) with Opdivo (nivolumab) in Patients with Advanced Solid Tumors (Press)
  • Astellas and Seattle Genetics Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer (Press)
  • vTv Therapeutics Initiates Phase 1b/2 Study Evaluating TTP399 for the Treatment of Type 1 Diabetes (Press)

Medical Devices

  • Heart valve replacement success may depend on age, valve type (Reuters)
  • IUDs linked to lower risk of cervical cancer (Reuters)
  • Stryker receives US FDA HDE approval for the Neuroform Atlas Stent System to treat wide neck aneurysms (Press)
  • Medtronic shares up on Q2 prelims, limited Hurricane impact (MassDevice) (Press)
  • FDA puts Second Sight Medical's next-gen Orion 'bionic eye' on the fast track (MassDevice)
  • Clearside Biomedical misses Q3 earnings estimates (Drug Delivery)
  • Glaukos shares fall despite Q3 beat (MassDevice)
  • 5 Reasons Big Medtech Companies Can (and Should) Innovate (MDDI)
  • Initiatives to Reduce Catheter-Related Complications Drive U.S. Vascular Access Devices and Accessories Market (MDDI)
  • DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2 Total Ankle Replacement System (Press)

US: Assorted & Government

  • Ohio Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs (HHS OIG)
  • Genentech Opposes Transfer Of Delaware Mvasi (Bevacizumab-Awwb) Litigation To California (Big Molecule Watch)
  • Actavis Ruling Bolsters Insurers In Opioid Coverage Battles (Law360-$)
  • Big Pharma Faces Insurance Hurdles In Opioid Suits (Law360-$)
  • Affiliate Drug Discount Exempt From Antitrust Law, FTC Says (Law360-$)
  • Amneal Gets OxyContin Patent Nixed At PTAB (Law360-$)
  • Nevada Scares Diabetes Drug Industry With Halloween List of "Essential Diabetes Drugs" (FDA Law Blog)
  • Here Is Why The False Claims Act Is An "Awkward Vehicle" In Pharma Cases (Drug & Device Law)
  • Ending Medical Tax Break Could Be a 'Gut Punch' to the Middle Class (NYTimes)
  • Marijuana Won Tuesday's Election (Forbes)
  • Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
  • Medtronic, Boston Scientific, St. Jude Medical escape catheter patent suit (MassDevice)

Upcoming Meetings & Events

Europe

  • NHS Chief in high-stakes gambit to boost funding in autumn budget (Pharmafile)
  • Seqirus announces £40m UK fill-and-finish flu vaccine facility (Pharmafile)
  • ABPI welcome appointment of Dr Patrick Vallance as Chief Scientific Adviser (ABPI)
  • Danes Shutter Drug Importer Over Quality Issues (FDANews-$)
  • WP4 PTJA01 on "Midostaurin (Rydapt©) with standard chemotherapy in FLT3 positive Acute Myeloid Leukaemia" is now available. (EUnetHTA)

Asia

  • Sosei eyes opportunity, takes back Japanese rights to dementia candidate (PharmaLetter-$)

India

  • CDSCO soon to begin inspections on drug testing labs to ensure compliance of D&C Rules (PharmaBiz)

Australia

  • Australia's TGA progresses Provisional Approval pathway for medicines (PharmaLetter-$)
  • Australian pharma industry welcomes government's approach to reforms (PharmaLetter-$)

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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