Regulatory Recon: FDA Halts Cellectis' Off-the-Shelf CAR-T Trial After Patient Death; Novartis Names New CEO (5 September 2017)

Posted 05 September 2017 By Michael Mezher

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

In Focus: US

  • Toxic reaction kills Cellectis' first CAR-T patient, forcing trial halt (Endpoints) (STAT) (Fierce) (Reuters) (Xconomy)
  • Novartis follows up on big CAR-T win by naming Vas Narasimhan as its new CEO (Endpoints) (Financial Times) (Reuters)
  • Cancer's Invasion Equation (The New Yorker)
  • At $475,000, new cancer drug raises thorny questions about drug pricing — and value (STAT)
  • Insmed shares soar as PhIII lung disease study proves positive, pointing to quick FDA pitch (Endpoints) (STAT) (Reuters)
  • Sanofi quietly pulls the plug on its Zika vaccine project (STAT) (Fierce) (Pharmafile)
  • New Blood Needed: Pharma R&D Leadership Tenure (LifeSciVC)
  • The First Count of Fentanyl Deaths in 2016: Up 540% in Three Years (NYTimes)
  • Opioids Aren't the Only Pain Drugs to Fear (NYTimes)
  • Medical device maker Teleflex to buy NeoTract in $1.1 billion deal (Reuters)
  • PhRMA, BIO push back against Nevada patent law (BioPharmaDive) (BIO)
  • DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again (RxTrace)

In Focus: International

  • Why Drugs Cost Less in the U.K. Than in the U.S. (Bloomberg)
  • Bain, Cinven give in to Elliott's demand for higher Stada buyout (Reuters) (Financial Times)
  • Emboldened by recent R&D successes, Merck KGaA looks at selling off $1B-plus consumer division (Endpoints) (Reuters)
  • Takeda partners with Noile-Immune on next-gen CAR-T pipeline for solid tumors (Endpoints) (Pharmafile)
  • Value Added Medicines: Time To Adjust The HTA Decision Frameworks For More Patient-Centric Innovation (Medicines for Europe)
  • EU regulator recommends pulling prolonged-release paracetamol (Reuters) (EMA)
  • EMA Mandates Use Of Simplified Form To Submit Post-Market Data (Pink Sheet-$) (EMA)
  • EMA Launches Survey on Patient, Doctor Awareness of Adverse Event Reporting (EMA)
  • UK biotech Destiny jumps 44% in market debut (Financial Times)
  • Patently problematic? The impact of the Eli Lilly/Actavis intellectual property battle (Pharmafile)
  • Roche's Alecensa gets green light for early access scheme (PharmaTimes) (MHRA)
  • Merck's Erbitux backed by NICE for head and neck cancer (PharmaTimes)
  • Shanghai's Tough Proposals For Medical Sales Reps Draw Ire (SCRIP-$)
  • OrbiMed lines up $551M gamble on China, India biotech sectors (Endpoints) (Financial Times)
  • No Pharmaceutical Extension of Patent Term for Swiss Type Claims in Australia (Patent Docs)

Pharmaceuticals & Biotechnology

  • ASCO spotlight presaged two more biotech IPOs angling for $215M (Endpoints)
  • Manufacturing Standards Key to Advancing Cellular and Gene Therapies (PharmTech)
  • OGD Delivers on First of Two Documents – Early! (Lachman Consultants)
  • A path to the brain's secrets (C&EN)
  • Brain researchers in uproar over NIH clinical-trials policy (Nature)
  • FDA's Advisory Cmte. Meeting On Bladder Pain Syndrome May Signal Policy Changes (Pink Sheet-$)
  • Asthma drugs reduce Parkinson's risk by 50%, decade-long study finds (Pharmafile)
  • Childhood cancer survivors may face decades of high medical costs (Reuters)
  • Some Physicians Switch Patients Off Invokana after FDA Warning (Medpage)
  • A Look Back: The AIDS Crisis and FDA … 30 Years Later (FDA Voice)
  • Lasting Merit Found in a Tuberculosis Vaccine Invented a Century Ago (NYTimes)
  • 'Meds-to-beds' programs aim to prevent re-hospitalization (Washington Post)
  • Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet (NPR)
  • FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues (CHC)
  • Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency (FDA)
  • Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues (FDA)
  • PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Ionis spinout Akcea files for approval of volanesorsen (Fierce)
  • Novartis celebrates success of Gilenya in paediatric multiple sclerosis (Pharmafile)
  • Acceleron Announces Publication of Luspatercept Phase 2 Myelodysplastic Syndromes Study Results in The Lancet Oncology (Press)
  • Sobi Receives Approval From the FDA for Once-Daily Dosing Frequency of Orfadin® (nitisinone) for the Treatment of HT-1 (Press)
  • FDA Grants Orphan Drug Status to Cellect's ApoGraft™ for Acute GvHD and Chronic GvHD (Press)
  • Eiger Announces FDA Orphan Drug Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection (Press)
  • Ligand Announces Top-Line Results from Phase 2 Study of LGD-6972 in Patients with Type 2 Diabetes (Press)
  • Bioventus Receives US FDA Approval for DUROLANE (Press)
  • Deciphera Pharmaceuticals Announces FDA Orphan Drug Designation for DCC-2618 for the Treatment of Glioblastoma Multiforme and Anaplastic Astrocytoma (Press)
  • ReViral initiates Phase 2a study of RV521 for treatment of Respiratory Syncytial Virus (Press)

Medical Devices

  • How to work with the new FDA (Medical Design & Outsourcing)
  • FDA clears mammography device with option for patient-assisted compression (FDA) (Medpage)
  • Baxter completes $270m Alabama facility expansion (MassDevice)
  • Adherium wins 510(k) clearance for smart inhaler monitoring device (Drug Delivery)
  • Apollo Endosurgery touts 20-year Lap-Band data (MassDevice)
  • LabCorp completes $1.2B Chiltern buy (Drug Delivery)
  • Medtronic Launches Long Term Clinical Study Program of INFUSE Bone Graft in Two Common Spine Procedures: PLF and TLIF (Press)
  • Sapheneia / Scannerside Announces FDA 510(K) Clearance for New 2nd Gen XR 29 Dose Check (Press)

US: Assorted & Government

  • Trump taps Pennsylvania congressman to be drug czar (Washington Post)
  • Federal Right To Try Legislation – Is It Any Better? (Drug & Device Law)
  • Amgen v. Sandoz: Next Biosimilar Bout Begins Over State Law Claims (Pink Sheet-$)
  • Court Rules Mylan, Chemical Companies Must Pay Insurers $67 Million (FDANews-$)
  • AIDS Groups Call on New York AG to Investigate Pay-For-Delay by Gilead (FDANews-$)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • FDA Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development – 30 October 2017
  • EMA Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting – 19 & 20 September 2017
  • EMA PSUR roadmap: joint industry/assessor training – 22 September 2017
  • Meeting of the Medical Imaging Drugs Advisory Committee Meeting Announcement – 8 September 2017

Europe

  • NHS needs emergency £350 million to survive winter (Pharmafile)
  • EU Extends Deadline For Comments On Review Of Tissues And Cells Legislation (Pink Sheet-$)
  • Mundipharma bags rights to sell Janssen's Invokana, Vokanamet (PharmaTimes)
  • EMA procedural advice for medicinal products intended exclusively for markets outside the European Union under Article 58 of Regulation (EC) No 726/2004 in the context of co-operation with the World Health Organisation (EMA)
  • Malaria May Be Back in Italy After Decades Amid 'Very Hot Summer' (NBC)

India

  • India's major healthcare system development (GOV.UK)
  • Fearing more price control, medical device companies propose government to voluntarily cut prices (Economic Times)
  • Roche Diagnostics India looks at 15 per cent IVD market share in 2 years (Economic Times)
  • PvPI registers 3 lakh adverse drug reactions, as it adds 40 more AMCs (PharmaBiz)
  • Jubilant Pharma completes Triad's US radiopharmacy acquisition (Economic Times)
  • Zydus Cadila gets USFDA nod for Mycophenolate Mofetil (Economic Times)
  • Setback for Singh brothers: SC declines permission to sell pledged shares in Fortis Healthcare (Economic Times)
  • Focus of Medical Devices Policy must shift from import substitution to global scale market creation: MtaI (PharmaBiz)
  • Consolidation of pharma distributors in US and mergers put pressure on profit margins of Indian companies: CARE Rating (PharmaBiz)
  • DoP raps NPPA for price fixation of erythromycin tabs for being contrary to DPCO provisions (PharmaBiz)
  • Lupin launches generic hypertension drug in US market (Economic Times)
  • Ajanta Pharma gets USFDA nod for Parkinson's disease tablet (Economic Times)

Australia

  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)
  • Consultation submission: The Scheduling Policy Framework and Advertising of Pharmacist-only medicines (Schedule 3 substances) (TGA)
  • Platinum ICDs and CRT-Ds (TGA)
  • Medical Devices Safety Update Volume 5, Number 5, September 2017 (TGA)

Other International

  • New Turkish Biosimilar Insulin Glargine Poses Challenge For Sanofi's Lantus (SCRIP-$)
  • Yemen's cholera epidemic hits 600,000, confounding expectations (Reuters)

General Health & Other Interesting Articles

  • Her weight loss and pain looked like cancer. The real reason was hidden for years. (Washington Post)
  • New Study Offers Support for Prostate Testing (NYTimes) (Reuters)
  • Triple Threat: New Pneumonia Is Drug-Resistant, Deadly And Contagious (NPR)

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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