Recon: DBV Withdraws Peanut Allergy BLA; Agenus, Gilead Partner on Immuno-Oncology – Regulatory Focus

Posted 20 December 2018 | By Michael Mezher 

Recon: DBV Withdraws Peanut Allergy BLA; Agenus, Gilead Partner on Immuno-Oncology
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Big Pharma returning to US price hikes in January after pause (Reuters)
  • Why The US Remains The World’s Most Expensive Market For ‘Biologic’ Drugs (KHN)
  • Agenus shares soar after cancer therapy deal with Gilead (Reuters) (Endpoints)
  • DBV pulls peanut allergy filing after FDA faults data details (Fierce) (Endpoints)
  • HHS recommends opioid overdose antidote to high-risk patients (Reuters) (AP)
  • Judge Blocks New York From Enforcing Opioid Surcharge on Companies (Reuters) (Law360-$)
  • Relay Therapeutics raises $400 million in venture capital funding (STAT) (Endpoints) (Press)
  • The right way to address prescription drug costs (STAT)
  • Trump administration report would preclude reclaiming patents as a way to lower drug prices (STAT)
  • AZ, Merck's Lynparza plows ahead in ovarian cancer with $1B-plus approval, phase 3 data (Endpoints) (Fierce) (Press)
  • Merck's Keytruda puts heat on Pfizer, Merck KGaA's Bavencio with new Merkel cell OK (Fierce) (Press)
  • The da Vinci surgical robot: A medical breakthrough with risks for patients (NBC)
  • The Apple Watch is giving patients control over their health, but some doctors say consumers are taking it too far (CNBC)

In Focus: International

  • A Year In, Novartis’ Boss Faces The World (Forbes)
  • Brexit: European Commission presents ‘no-deal' contingency plans (DW) (BBC) (Emergo) (Pink Sheet-$)
  • Post-Brexit immigration policy has a critical missing piece (PMLive) (PharmaTimes)
  • EU Servier Court Ruling ‘Reduces Competition Law Risks For Pharma' (Pink Sheet-$)
  • South Korean pharma laid low by global retreat and Samsung scandal (Nikkei Asian Review)
  • Merck KGaA hands off its CAR-T R&D operations to Intrexon in $175M deal (Endpoints)
  • AstraZeneca's ovarian cancer and anemia treatments meet goals in late-stage studies (Reuters)  (Endpoints) (AstraZeneca) (FibroGen)
  • 140 jobs in jeopardy as Recipharm weighs the fate of money-losing plant (Fierce)
  • Dengvaxia approved for dengue in EU (PharmaTimes)
  • NICE publishes updated guidance with expanded recommendation for Oncotype DX (PharmaTimes)

Pharmaceuticals & Biotechnology

  • Sen. Warren’s Generic Drug Idea (In the Pipeline)
  • Massachusetts is trying to make the Berkshires a biotech hub. Can it succeed where so many other cities have failed? (STAT)
  • Top Cancer Doctor Resigns as Editor of Medical Journal (NYTimes)
  • Supernus Pharma's ADHD drug meets main goal in study on adolescents (Reuters) (Endpoints)
  • Gilead, Scholar Rock Sign $80M Up Front Deal for Fibrosis Drugs (Xconomy)
  • FDA turns thumbs down on Spectrum’s ‘breakthrough’ pitch for cancer drug poziotinib and shares tumble (Endpoints)
  • Lilly lays out sunny 2019 forecast driven by growth of new diabetes, psoriasis and cancer drugs (Fierce)
  • US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too (Pink Sheet-$)
  • US FDA's Robert Temple And Signatory Authority: Teacher And Back-Up (Pink Sheet-$)
  • As immuno-oncology heads into 2019, one thing is clear: It’s good to be Merck (Fierce)
  • OTC Switch For Naloxone Finding Interest Among Sponsors (Pink Sheet-$)
  • Cocaine Anesthetic Not FDA-Approved, Rival Drugmaker Says (Law360-$)
  • The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more? (Fierce)
  • Discovering translational biomarkers in neurodevelopmental disorders (Nature)
  • Google’s GV enlists machine learning pro Rosana Kapeller in its drive to create a new breed of biotech (Endpoints)
  • Real World Evidence at the FDA (The Incidental Economist)
  • It’s Time to Reform the Orphan Drug Act (NEJM Catalyst)
  • Biotech bound, Liz Barrett passes Novartis’ top oncology job to Susanne Schaffert (Endpoints)
  • G1 tanks after placebo beats drug in cancer response rate test (Fierce)
  • No peak in sight: Cancer marketing spreads across media landscape, from TV to digital (Fierce)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • Chugai gains FDA breakthrough status for rare CNS treatment (PMLive)
  • Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer (Press)
  • Omeros Establishes Independent Academic Leadership Committee for its OMS721 Phase 3 Clinical Program in IgA Nephropathy (Press)
  • Deciphera Pharmaceuticals Initiates Pivotal Phase 3 Clinical Study of Ripretinib (DCC-2618) in Second-line Patients with Gastrointestinal Stromal Tumors (“INTRIGUE” Study) (Press)
  • Kalytera Provides Update on Phase 2 Clinical Study Evaluating CBD in Prevention of Acute GVHD (Press)
  • Da Volterra Announces Enrollment of First Patients in SHIELD, a Phase 2 Clinical Trial with DAV132, a Novel Microbiota Protective Therapy (Press)
  • Cerus Announces First Patient Enrolled in the Phase 3 ReCePI Study (Press)
  • European Medicines Agency Grants Orphan Drug Designation for Xeris’ Investigational Ready-to-Use Glucagon for the Treatment of Non-Insulinoma Pancreatogenous Hypoglycaemia Syndrome (NIPHS) (Press)
  • Janssen Announces European Commission Approval of Darzalex (daratumumab) Split Dosing Regimen (Press)

Medical Devices

  • FDA CDx Class Labeling Draft Guidance May Ease Patient Access, Spur Competition Among Test Makers (GenomeWeb)
  • Concepta Diagnostics launches new tool to track ovulation (mobihealthnews)
  • Haemonetics relocates HQ to downtown Boston (MassDevice)
  • FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device (MassDevice)
  • Cerus launches US pivotal, bids for CE Mark for Intercept red blood cell treatment (MassDevice)
  • Kleresca cleared to enter Australian, Canadian markets (Medical Design & Outsourcing)

US: Assorted & Government

  • J&J loses bid to have $4.7 billion talc verdict set aside, vows to appeal (Reuters)
  • New Hatch-Waxman Integrity Act Brings Hope For Patients (Law360-$)
  • Fresenius Gets Win In Suit Over Hospira Sedative Patents (Law360-$)
  • Judge signals skepticism in Trump team's bid to block Obamacare suit (Reuters)
  • Facing oversight, Trump's ACA defense strategy is taking shape (Politico)
  • DOJ Wants It Both Ways: Case Satisfies Materiality Standard, but Still Merits Dismissal (FDA Law Blog)
  • Sign-ups for 2019 Obamacare insurance fall to 8.5 million people (Reuters) (NYTimes)
  • VA Was “Taken Advantage Of” by Paying Billions in Fees, Secretary Says (ProPublica)
  • Cigna-Express Scripts Merger A Done Deal By Thursday (Forbes)
  • Walgreens And Alphabet's Verily Partner To Cut Health Costs (Forbes)
  • Former President Of Billionaire-Owned Hearing Aid Manufacturer Sentenced To 7 Years In Prison (Forbes)
  • Embattled Rite Aid Gets Rare Win With New 10-Year McKesson Deal (Forbes)
  • Judge dismisses lawsuit accusing Craig Venter of stealing trade secrets (STAT)
  • Juul May Get Billions in Deal With One of World’s Largest Tobacco Companies (NYTimes)

Upcoming Meetings & Events
Europe

  • MHRA statement on Allergan (MHRA)
  • Roche Secures EU Fast-Track Review For Anticancers (Pink Sheet-$)

India

  • Ranbaxy to ruins: How the Singh brothers turned from business whizkids to fraud accused (Economic Times)

Australia

  • Consultation: Medical device cyber security (TGA)

Canada

  • Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality (Health Canada)

Other International

  • Brazilian doctors fail to report for duty to replace Cubans (Reuters)

General Health & Other Interesting Articles

  • Child death rates far higher in U.S. than in other developed countries (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? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Source: https://www.raps.org/news-and-articles/news-articles/2018/12/recon-dbv-withdraws-peanut-allergy-bla-agenus-g


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