Regulatory Focus™ > News Articles > Regulatory Recon: World Bank Launches Pandemic Bond; Final NICE OK for Sanofi Gaucher Drug (29 June

Regulatory Recon: World Bank Launches Pandemic Bond Final NICE OK for Sanofi Gaucher Drug (29 June 2017)

Posted 29 June 2017 | By Michael Mezher 

Regulatory Recon: World Bank Launches Pandemic Bond Final NICE OK for Sanofi Gaucher Drug (29 June 2017)

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

In Focus: US

  • Scrambling for deal, Senate GOP offers $45 billion for opioid crisis (Politico) (Reuters)
  • Top investor slashes Moderna's valuation as company struggles to live up to its own hype (STAT)
  • Sales hopes for new Novartis, Merck heart drugs under microscope (Reuters)
  • Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting (Pink Sheet-$)
  • Vivitrol offers the fantasy of being drug-free. But that's not the most important thing in tackling addiction (STAT)
  • AstraZeneca, Chi-Med take kidney cancer drug into final testing (Reuters) (Press)
  • Seniors Miss Out On Clinical Trials (KHN)
  • Gene Therapy Reimbursement: Is Blindness A Bad First Test? (Pink Sheet-$)
  • Hunt for enzymes heats up, a potential boon for biotech and beyond (STAT)
  • Allergan vet Doug Ingram takes the helm of a storm-tossed Sarepta (Endpoints) (STAT) (Fierce)
  • Atlas Venture vows to keep doing well by doing good with its new, $350M biotech fund (Endpoints) (LifeSciVC)
  • Pfizer starts work on $236M biotherapeutics facility in Missouri (Fierce)
  • ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II (FDA Law Blog)
  • A Reality Check for IBM's AI Ambitions (MIT Technology Review)
  • Organoids Proposed to Screen Patients for High-Priced Drugs (MIT Technology Review)
  • Noninvasive Brain Stimulation for Depression — The Devil Is in the Dosing (NEJM, Study)
  • Vectura signs deal with Novartis for generic US lung therapy (Reuters)
  • First test FDA-approved for use with multiple cancer drugs (BioWorld)

In Focus: International

  • World Bank launches 'pandemic bond' to tackle major outbreaks (Reuters)
  • Malawi, UNICEF launch Africa's first humanitarian drone testing corridor (Reuters)
  • China eyes healthcare payment shake-up to trim costs (Reuters)
  • Final NICE nod for Sanofi's Gaucher therapy (PharmaTimes)
  • EFPIA, EBE and Vaccines Europe Back EU Leadership in Sustainable, Collaborative Fight Against AMR (EFPIA)
  • Two New Italian €500m Funds for Innovative Drugs for Cancer, Hep C (Pink Sheet-$)
  • 'Affordable' Russian Rituximab Biosimilar On Course In India (SCRIP-$)
  • Regulators get aggressive on matters excessive (Pharmafile)
  • Pfizer: Global regulatory divergence restricted continuous manufacturing ambition (InPharmaTechnologist)
  • Novartis gets first-line approval for Xalkori challenger in EU (PMLive) (Pharmafile)
  • Eisai temporarily withdraws cancer drug NDA in China (PharmaLetter-$)
  • Open Innovation: The Fast-Track To Global Pharma Power For Korea? (SCRIP-$)
  • Sosei Group subsidiary Heptares enters strategic collaboration with PeptiDream (Reuters) (PharmaLetter-$)
  • Experimental sickle cell disease drug gets PRIME status (PharmaTimes)
  • Chinese biopharma starts feeding the global pipeline (Nature)
  • Finding fault with Bial's fatal FAAH inhibitor (Nature)

Pharmaceuticals & Biotechnology

  • Biotech R&D spending continues to rise (Nature)
  • Insect Venom Shortage Stings Allergy Sufferers This Summer (KHN)
  • Investors demand resignation of Mylan executives over pay packages (Pharmafile)
  • FDA Consults on Enhanced Review Program for Biosimilars under BSUFA II (FDA)
  • FDA Issues Form 483 to Shiraz Specialty Pharmacy (FDA)
  • Better Incentives Needed For Worsening Fungal Infection Threat (SCRIP-$)
  • Altor shareholders revolt against Soon-Shiong buyout (Fierce)
  • Vaccination: The Best Return on Investment (IEEE Spectrum)
  • Macrophages steal the show (Nature)
  • Waiver for Conflicts of Interest for the July 13, 2017 Meeting of the Oncologic Drugs Advisory Committee (ODAC) (FDA)
  • Need proof that CV outcomes are make-or-break? See Merck's reaction to anacetrapib trial win (Fierce)
  • MERSANA DIPS AFTER $75M IPO (BioCentury)
  • Scholar Rock Developing Lead Candidate For SMA (BioCentury)
  • Marijuana Treats Migraine Pain Better Than Prescription Medication, Study Finds (Forbes)
  • More clinical applications, more problems, says Veeva (OutsourcingPharma)
  • Vivace uncloaks with $40M, U.S.-China backing for cancer trials (Fierce)
  • Personalised medicine, batch size of ONE, the new challenge to fill-finish? (EPR)
  • Teva CEO eyes disruption from tech companies (PharmaLetter-$)
  • Mehta Analysis: Shaming Biopharma Managers (SCRIP-$)
  • Another biotech IPO boasting a pharma castoff rings the bell on Wall Street with $75M haul (Endpoints)
  • Investors — and AstraZeneca CEO Pascal Soriot — are getting a tad nervous as MYSTIC data loom (Endpoints)
  • Investigational antibody boosts chemotherapy's cancer-killing potential (Pharmafile)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA will review Plenvu, in-licensed by Valeant (PharmaLetter-$)
  • Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Rituxan® (rituximab) (Press)
  • New Data Reaffirm Clinically Meaningful Benefit of SPINRAZA® (nusinersen) in Individuals with Spinal Muscular Atrophy Across Disease Severity (Press)
  • Aerpio Announces Initiation of Patient Dosing in the TIME-2b Study, a Phase 2b Clinical Trial of Lead Candidate AKB-9778 in Patients with Diabetic Retinopathy (Press)

Medical Devices

  • Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus (FDA)
  • K2M wins FDA nod for Capri 3D-printed corpectomy cage (Medical Design & Outsourcing)
  • Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia® 2 Instrument for Use with Sofia Respiratory Syncytial Virus (RSV) Assay (Press)
  • InVivo touts 2 patient recoveries in Inspire trial (MassDevice)

US: Assorted & Government

  • FTC Requests Public Comment on Application from Grifols, S.A. to Amend Contract Manufacturing Agreement that was part of 2011 Divestiture Ordered by the Agency (FTC)
  • Drop In Sudden Cardiac Arrests Linked To Obamacare (KHN)
  • FDA Commissioner's Fellowship – Applications Due 7 July 2017 (FDA)
  • Ohio lawmakers vote to freeze Medicaid expansion (Reuters)
  • Harmonization of Clinical Research Requirements—Conflicting Common Rule and CLIA Requirements Come under Microscope (National Law Review)
  • As Congress battles over healthcare, Johnson & Johnson CEO says real reform will take time—and cooperation (Fierce)
  • Pfizer, Direct Buyers Duel For Quick Wins In Celebrex Suit (Law360-$)
  • Amgen, Hospira Battle Over Experts Ahead Of Patent Trial Law360-$)
  • The Third Circuit and Fraudulent Joinder (Drug & Device Law)
  • Chicago Releases Pharmaceutical Representative Disclosure Log Draft (Policy & Medicine)
  • Hologic files infringement suit against Fujifilm Medical over mammogram tech (MassDevice)

Upcoming Meetings & Events

Europe

  • UK Researchers in world-first study on antibiotic use for sepsis (Pharmafile)
  • NEW: The MEDICRIME Convention in a few words (EDQM)
  • BASF to spend €200m to up ibuprofen capacity in Europe and US (InPharmaTechnologist)
  • DHL opens new state-of-the-art Life Sciences facility at Dublin Airport (EPR)
  • Regenacy names new President and CEO (Pharmafile)
  • Bulgaria to press EU over 'double standards' in food products (Reuters)
  • Luminex Receives CE Mark for Aries Acute Gastroenteritis Assay (GenomeWeb)

India

  • India's oldest pharma company Bengal Chemicals turns profitable after 64 years but faces privatisation blues (Economic Times)
  • Legal tussle to recover Rs 3,500 crore: Daiichi moves NCLT to block Fortis demerge (Economic Times)
  • Pharma companies still facing GST rollout blues (Economic Times)
  • NPPA works out provisional ceiling prices of 761 formulations towards GST implementation (PharmaBiz)
  • DTAB approves DCC recommendations for uniform implementation of provisions of D&C Act and Rules throughout the country (PharmaBiz)

Asia

Canada

Australia

  • Medicines Safety Update, Volume 8 Number 3, June 2017 (TGA)]
  • Scheduling delegate's final decisions, June 2017 (TGA)
  • Minor variations to prescription medicines (TGA)
  • Conformity assessment (TGA)
  • Conformity assessment Certificate Repository (TGA)

General Health & Other Interesting Articles

  • Fewer U.S. cancer survivors breathing secondhand smoke (Reuters)
  • Mutant Strains Of Polio Vaccine Now Cause More Paralysis Than Wild Polio (NPR)
  • NIAID scientists identify cause, possible treatment for life-threatening gut condition (NIH)
  • NIH study sheds light on immune responses driving obesity-induced liver disease (NIH)

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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