Regulatory Recon: Novartis Eyes First FDA CAR-T Approval; FDA Rejects Mylan's Generic of GSK's Advair (30 March 2017)

Posted 30 March 2017 By Michael Mezher

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

In Focus: US

  • Novartis Makes Plans For Its Cancer-Killing T Cells (Forbes) (Pharmafile) (Fierce) (Reuters)
  • FDA declines to approve Mylan's generic of GSK's Advair for now (Reuters 1, 2) (Law360-$)
  • Novartis loses battle with the feds over documents for 80,000 'sham' events (STAT)
  • Scientific Drought, Golden Eggs, and Global Leadership — Why Trump's NIH Funding Cuts Would Be a Disaster (NEJM)
  • No One Prays for an iPhone, Says Drug Exec Slamming Trump Cuts (Bloomberg)
  • Scott Gottlieb and the Credibility of US Therapeutics (NEJM)
  • An FDA Commissioner for the 21st Century (NEJM)
  • TransCelerate makes progress (Nature)
  • Is Vertex's New CF Drug Unprecedented? Incremental? Expensive? Maybe All Three (Forbes) (SCRIP-$)
  • This federal agency that aims to make health care more effective is on the chopping block, again (STAT)
  • Democrats Propose Wide-Ranging Bill to Lower Drug Costs (Focus)
  • House Bill Seeks to Expand Off-Label 'Scientific Exchange' Between Industry, Doctors (Focus)
  • HHS Secretary Working With Trump on a Plan to Reduce Drug Prices (Focus)
  • FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval (Focus)
  • GSK sets out to crack 'undruggable' targets, with a little help from Warp Drive Bio (Fierce) (PharmaLetter-$)
  • Corbus brags about another PhII success for its lead drug, but shares slide early (Endpoints) (The Street) (Reuters) (Fierce)
  • Democratic Senator Urges Trump To 'Do More Than Talk' On Opioid Crisis (NPR)
  • Senators Demand Answers About Possible Probe Of HHS Secretary Price (KHN)
  • Health secretary pledges to uphold Obamacare, but promote it, not so much (CNBC)
  • House Hearing on Cybersecurity in Health Care Sector Set for 4 April (E&C)
  • Senate HELP Committee Schedules Hearing for Gottlieb Nomination (HELP)

In Focus: International

  • PRIME time at the EMA (Nature)
  • UK Triggers Brexit: What's Next for the UK, MHRA and EMA? (Focus) (ABPI)
  • Dublin "ideal location" for EMA post-Brexit, says IDA's Tommy Fanning (PharmaLetter)
  • Singapore confirms two new cases of Zika virus (Reuters)
  • Fewer Zika-Linked Birth Defects Than Expected (NPR) (STAT)
  • Pfizer Proposes to Make Viagra Available in the UK Without a Prescription (Focus)
  • Zara founder to spend $344 million on breast cancer-screening for Spanish hospitals (Reuters)
  • 'Let's Talk', WHO says, as depression rates rise 18 percent in a decade (Reuters) (WHO)
  • Siemens CEO Kaeser: We'll keep a majority stake in Healthineers after split (MassDevice)
  • Orphan status for GW's rare epilepsy drug (PharmaTimes)
  • AZ' neuromyelitis drug picks up Orphan status in EU (PharmaTimes)
  • Data Add to Strengthening Efficacy Case for Takeda Dengue Vaccine (SCRIP-$) (Press) (The Lancet)
  • India's E-Plan to Map Drug Sales – Turning Point for Better Traceability? (Pink Sheet-$)
  • BioPharma Credit Raises $762 Million in IPO (LSEG)

US: Pharmaceuticals & Biotechnology

  • All roads lead to EZH2 inhibition (Nature)
  • From Trial to Target Populations — Calibrating Real-World Data (NEJM)
  • Q&A: Three big mistakes drug companies make in recruiting new employees (STAT)
  • Genentech says FDA advisory committee unanimously recommends approval of co's subcutaneous rituximab for certain blood cancers (Reuters) (Press)
  • Genentech's Early Cancer Technology Scout On Partnering, Roche Setup & BD Challenges (SCRIP-$)
  • Incyte cash boost not enough to stave off major Agenus cuts (Fierce)
  • RA pipeline drugs unlikely to address unmet needs by 2025, says report (PharmaLetter-$)
  • Serialisation reconciliation: a blind spot in your finished product's manufacturing compliance? (EPR)
  • Gilead's Harvoni ads go from before to after with new creative focused on hep C cure (Fierce)
  • Third Rock's Tango Aims For Drugs That Turn Cancer Against Itself (Xconomy) (Endpoints)
  • Solid Biosciences appears to be prepping for an IPO with $50M round for Duchenne gene therapy (Endpoints) (Xconomy)
  • Bristol-Myers Squibb Enters Collaboration to Leverage Foundation Medicine's Molecular Information Platform to Identify Predictive Biomarkers Across Multiple Tumor Types and Immunotherapy Agents (Press)
  • Maternal Immunization (NEJM)
  • Use of the National Heart, Lung, and Blood Institute Data Repository (NEJM)
  • FDA Draft Guidance on Acyclovir Enables Diteba's Novel IV Approach to Achieve Biowaiver Status, Replacing Clinical Trials (Press)
  • HPV vaccination during pregnancy shows no ill effects (Reuters)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • FDA Grants Priority Review For Amgen's BLINCYTO® (blinatumomab) Supplemental Biologics License Application (Press)
  • Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017 (Press) (PharmaLetter-$)
  • FDA Division of Hematology Products Lifts Partial Clinical Hold on Karyopharm's Selinexor Clinical Trials (Press)
  • FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's HUMIRA (adalimumab) Prescribing Information (Press)
  • Aura Biosciences Announces Initiation of Phase 1b Clinical Trial and Receipt of FDA Fast Track Designation for AU-011 for the Treatment of Primary Ocular Melanoma (Press)
  • FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents (Press)
  • First-in-Human Genolimzumab Phase 1 Study Initiated to Assess Safety and Preliminary Efficacy in Patients with Select Advanced Solid Tumors (Press)
  • Spectrum Pharmaceuticals Announces Initiation of a Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations (Press)
  • Omeros Reports More Positive Data in OMS721 Phase 2 Trial in Renal Diseases (Press)

US: Medical Devices

  • Device Thrombosis with Bioresorbable Scaffolds (NEJM)
  • Increasing Demand and Patent Applications for Medical Technology (MDDI)
  • Our Medical Future Through the Lens of Smart Glasses (MDDI)
  • ADM Cleveland: Here are some top medtech manufacturing highlights (MassDevice)
  • Siemens Medical wins $4B DoD radiology supply contract (MassDevice)
  • NuVasive wins 1st FDA nod for CoRoent multi-level cervical implant (MassDevice)
  • Merit Medical prices $136.5m offering (MassDevice)
  • Boston Scientific puts up $435m for Symetis just ahead of IPO (MassDevice)
  • Qiagen Launches First FDA-cleared JAK2 Test for Certain Type of Leukemia (Press)
  • Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System (Press)

US: Assorted & Government

  • The Hidden Orange Book: Breaking Up Is Hard to Do (But Sometimes It's for the Best) (FDA Law Blog)
  • Bristol-Myers Squibb Settles Off-Label Promotion Case for $19.5 Million (Policy & Medicine)
  • User Fee Bill Could Become Ensnared In US Abortion Politics (Pink Sheet-$)
  • Update – Which Decisions Have Excluded Dr. Parisian, And About What? (Drug & Device Law)
  • Pleading Civil RICO: Lessons From The Abbott Litigation (Law360-$)
  • Allergan Gets Patent Claims In Botox Suit Nixed At PTAB (Law360-$)
  • FTC Tells DC Circ. To Undo Boehringer Doc Privilege Ruling (Law360-$)

Upcoming Meetings & Events

Europe                                               

  • Novo to buy 20% stake in UK's ConvaTec (PharmaTimes)
  • PE Firms Collect $1.2B In Sale Of ConvaTec Shares (Law360-$)
  • President Juncker and Commissioner Moedas Appoint New EGE to advise Commission (EC)
  • Following industry trend, Merck offloads mid-stage immunology candidate (PharmaLetter-$)
  • Editas Competitor CRISPR Therapeutics Hails European Patent Decision (SCRIP-$)
  • Medical devices: Virtual Manufacturing replaces Own Brand Labelling (MHRA)
  • Proposal to make Dovonex Psoriasis 50mg Ointment available from Pharmacies (MHRA)
  • NHS workforce expands but GP numbers decline (PharmaTimes)

Asia

  • Takeda names new president of Europe and Canada business unit (PharmaLetter-$)
  • Japanese firm behind nivolumab looks to Numab Therapeutics for next discovery (PharmaLetter-$)
  • New treatment for rare form of non-Hodgkin lymphoma approved in Japan (PharmaLetter-$)
  • Vietnamese rituximab biosimilar boost brings more good news to Biocad expansion plans (PharmaLetter-$)

India

  • Doctors, pharmacists must report ADRs to regulatory authorities without delay: Dr Y K Gupta (PharmaBiz)
  • Gujarat FDCA to step up its vigilance on cardiac centres for overcharging coronary stents (PharmaBiz)
  • Alkem Labs gets inspection report from USFDA for Gujarat API facility (Economic Times)
  • Daiichi Sankyo wants external audit of details given by Singh brothers (Economic Times)
  • Aurobindo Pharma gets USFDA nod for HIV drug (Economic Times)

Other International

  • Argentina lawmakers approve cannabis oil for medicinal use (Reuters)
  • New WHO Public Assessment Report published for Rifampicin Capsules (WHO)

General Health & Other Interesting Articles

  • Interventional Cardiologists Face Major Obstruction In Treatment Of Total Blockages (CardioBrief)
  • More Women With Breast Cancer Opt to Remove Healthy Breast (NYTimes)
  • Estrogen for osteoporosis tied to lower risk of gum infections (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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