Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allerga

Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis Allergan Acquires Ailing Repros (12 December 2017)

Posted 12 December 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis Allergan Acquires Ailing Repros (12 December 2017)

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

In Focus: US

  • FDA warns companies for promoting alternatives to street drugs (FDA)
  • FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis (FDA)
  • Allergan buys an ailing Repros, bagging a women's health drug for the pipeline (Endpoints)
  • FDA Plans New Medical-Device Approval Processes (WSJ) (Reuters) (FDAVoice)
  • Three more drug makers allegedly used nurses to promote medicines (STAT)
  • FDA Finalizes Guidance on Promotional Drug Labeling and Ads (Focus)
  • Sanofi issues US-wide recall for arthritis product, after adverse events (Pharmafile) (Boston Globe)
  • FDA OKs Sanofi's follow-on biologic of Lilly's diabetes drug Humalog (Reuters) (FDA)
  • And now, your nominees for worst biopharma CEO of 2017. Let the voting begin! (STAT
  • FDA accepts application for Indivior's new schizophrenia drug (Reuters)
  • Lilly files anti-CGRP drug for migraine (PharmaTimes)
  • Experts Tell Congress How To Cut Drug Prices (KHN)
  • Amgen's Kyprolis improves overall survival in blood cancer patients (Reuters)
  • Allergan pads women's health pipeline with Repros buyout (Fierce)
  • Breast cancer in 2017: Spurring science, marking progress, and influencing history (Nature)
  • Top health industry issues of 2018 (PwC)

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In Focus: International

  • UK's NICE Aims To Knock Firms' Health Economic Models Into Shape (Pink Sheet-$)
  • Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations) (EC)
  • Sanofi investors hungry for drug progress and deal news (Reuters)
  • Sanofi's R&D day poses some big challenges as skeptics circle in wake of a Dengvaxia fiasco (Endpoints) (Fierce)
  • "Safeguarding public health must be number one priority" for EU27 and UK Government in phase two of Brexit talks (ABPI)
  • Final NHS 'no' for obesity pill Mysimba (PharmaTimes)
  • Scotland approves NHS funding for Ibrance, Cerdelga and Invicorp (PharmaTimes)
  • CanniMed asks Canadian regulators to intervene in hostile Aurora bid (Reuters)
  • WHO Report Finds No Public Health Risks Or Abuse Potential For CBD (Forbes)
  • NZ's Fisher & Paykel sues Resmed in Australia over patent dispute (Reuters)
  • Cholera resurges in Zambian capital Lusaka, WHO says (Reuters)

ASH2017 Roundup:

  • Adding precision to multiple myeloma treatments with DNA sequencing (Fierce)
  • GSK offers encouraging data on BCMA-targeting armed antibody, setting stage for a return to late-stage cancer studies (Endpoints)
  • Phase 2 data for Roche's lymphoma ADC doesn't disappoint (Fierce)
  • Spark triggers a backlash as early hemophilia A gene therapy data looks shaky (Endpoints)
  • Johnson & Johnson scores big Darzalex win in first-line myeloma, slashing risks in half (Fierce)
  • AbbVie, Roche boast stellar PhIII leukemia data for a "breakthrough" combo with blockbuster ambitions (Endpoints) (Fierce) (Press)
  • Astellas Announces First Clinical Data from Phase I Study of Gilteritinib in Combination with Intensive Chemotherapy in Patients Newly Diagnosed with Acute Myeloid Leukemia (Press)
  • Kyowa Hakko Kirin Announces Results of Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma (Press)
  • Seattle Genetics and Bristol-Myers Squibb Highlight Interim Results from Phase 1/2 Study Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Relapsed or Refractory Hodgkin Lymphoma (Press)
  • Verastem Announces the Presentation of Phase 1 Duvelisib Combination Data in T-Cell Lymphomas (Press)
  • Daiichi Sankyo Presents Phase 1 Data for EZH1/2 Dual Inhibitor DS-3201 in Patients with Non-Hodgkin Lymphomas (Press)

Pharmaceuticals & Biotechnology                                                                    

  • Opioid painkiller prescriptions may run in families (Reuters) (Forbes)
  • Digital Pills Track How Patients Use Opioids (MIT Technology Review)
  • An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs (KHN)
  • PsiOxus banks first milestone for BMS-backed cancer therapy (Fierce)
  • Ex-Dezima execs scoop €25M for midphase NASH trial (Fierce)
  • Why A Pill That's 4 Cents In Tanzania Costs Up To $400 In The US (NPR)
  • Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen (Pink Sheet-$)
  • Execution drugs are scarce. Here's how one doctor decided to go with opioids. (Washington Post)
  • New NIH consortium award to enhance clinical trials for Alzheimer's disease, related dementias (NIH)
  • Identifying Deceptive Rx Advertising: FDA Rejects PhRMA's Criticisms Of Its Study (Pink Sheet-$)
  • FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1 (Pink Sheet-$)
  • FDA Hits Glenmark for Quality Controls, Complaint Handling (FDANews-$)
  • FDA's Complete Responses to Generic Drugmakers Continue to Outpace Fiscal 2017 (FDANews-$)
  • Blue Cross to limit opioid scripts to 30-day supply (Modern Healthcare)
  • Aduro buries another cancer vaccine after CRS-207 joins the lineup of clinical disasters (Endpoints)
  • Otsuka pharma teams up with 'site-less' clinical trials firm to accelerate research (Outsourcing Pharma)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Omeros Corporation Announces FDA Approval of OMIDRIA® for Use in Pediatric Patients (Press)
  • Tiziana Life Sciences Announces Safety of Milciclib in a Phase 2a Trial in Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Patients (Press)
  • Promising responses seen with Agios leukemia drug in study (Reuters)
  • CEL-SCI Reaches Full Enrollment in Pivotal Phase 3 Head and Neck Cancer Study (Press)
  • Bioverativ's Investigational BIVV009 Demonstrates Safety, Tolerability and Efficacy in Phase 1b Clinical Trial in Cold Agglutinin Disease (CAgD) Patients (Press)
  • TapImmune Announces Enrollment of First Patient in Phase 2 Clinical Trial for Treating Triple-Negative Breast Cancer Funded by U.S. Department of Defense (Press)
  • Constellation Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 PROSTAR Combination Study of CPI-1205 in Advanced Form of Prostate Cancer (Press)
  • Tremeau and FDA Agree on Phase III Plan for Rofecoxib as a Non-Opioid Pain Treatment for Hemophilic Arthropathy (Press)

Medical Devices

  • What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More (Focus)
  • BD looks to beef up cybersecurity with new product security partnership program (MassDevice)
  • Zoll Medical wins $400m DoD vital signs monitor supply contract (MassDevice)
  • Boston Scientific Receives U.S. FDA Approval for the Vercise™ Deep Brain Stimulation System (Press)
  • Timing of Intersect ENT's approval is on the nose (EP Vantage)
  • Allergan Receives FDA Clearance For the CoolSculpting® Treatment To Improve Appearance Of Lax Tissue In The Double Chin (Press)
  • How Much Should Device Designers Really Know about Micro-Coaxial or Twin-Axial Cables? (MDDI)
  • SetPoint Medical wins FDA IDE trial nod for rheumatoid arthritis implant trial (MassDevice)
  • Medtronic Scoops Up an Irish Endoscopy Diagnostics Player (MDDI) (MassDevice)
  • Philips acquires cloud-based pop health co VitalHealth (MassDevice)

US: Assorted & Government

  • Magistrate Judge Recommends Dismissal of Amgen v. Coherus (Pegfilgrastim) Suit (Big Molecule Watch)
  • Medical lab trade group sues over US reimbursement cuts (Reuters)
  • Johnson, Meadows back legislation scrapping multi-state plan program (Politico)
  • VA spent $1.1 billion in five years on EHR modernization (Modern Healthcare)
  • Puma Biotech Investor Class Certified In Stock Drop Case (Law360-$)
  • Teva dismisses litigation after Mylan wins US court ruling on Copaxone (PharmaLetter-$)
  • Fed. Circ. Upholds Ruling Axing Forest's Namenda Patents (Law360-$)
  • Endo Escapes Faulty Pelvic Mesh Suit On Appeal (Law360-$)
  • Protecting Reasonable Physician Choice in Medical Product Cases (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • First guidance on monoclonal antibodies for use in animals (EMA)
  • ABPI a lead partner in new Clinical Pharmacology Skills Alliance (ABPI)
  • Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines (EMA)
  • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (Revised – Track Changes)
  • European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (Revised – Track Changes)
  • QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP) (EMA)
  • Health secretary urges people to talk to each other about organ donation (MHRA)
  • Compilation of QRD decisions on stylistic matters in product information (EMA)
  • EU health and food safety experts warn of stubborn salmonella (Reuters)
  • CTI acquires Eurotrials to create 'one of the 20 largest CROs in the world' (Outsourcing Pharma)
  • LSP Closes Second Health Economic Fund At €280m (BioCentury)

Asia

  • Beigene Falls On Immune Events For B Cell Cancer Combo (BioCentury)
  • Taiwanese firm presents positive data on new long-acting interferon for rare cancer (PharmaLetter-$)
  • Ardelyx signs a Chinese commercialization deal for GI drug (BioPharmaDive)
  • Fosun Pharma gets rights to tenapanor in China (PharmaLetter-$)

India

  • Alembic Pharmaceuticals gets USFDA go-ahead for bladder drug (Economic Times)

Australia

  • TGA Presentations: Complementary medicine reforms information sessions, November-December 2017 (TGA)

Other International

  • Mundipharma acquires Middle East and Africa rights for ophthalmology portfolio (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.


Categories: Recon, Regulatory News

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