Regulatory Focus™ > News Articles > 12 > Recon: Amgen’s Bispecific Antibody Gets Fast Track for Multiple Myeloma

Recon: Amgen’s Bispecific Antibody Gets Fast Track for Multiple Myeloma

Posted 04 December 2018 | By Michael Mezher 

Recon: Amgen’s Bispecific Antibody Gets Fast Track for Multiple Myeloma

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • There Is a Magic Bullet for Some Cancers. What If It Misses? (Bloomberg)
  • Amgen antibody shows promise in myeloma trial, gets FDA fast track (Reuters) (Endpoints) (Press)
  • Insulin Quest: When Lifesaving Drugs Are Out of Reach (WSJ)
  • For one cancer patient, biotech’s genetic test turns out to be a ‘lifesaver’ (STAT)
  • Drug ‘rebate walls’ should be dismantled by the FTC’s antitrust arm (STAT) (Endpoints)
  • Revance Therapeutics' frown lines treatment succeeds in late-stage trial (Reuters)
  • Bluebird’s gene therapy improved outcomes for patients, as push for filing gains steam (STAT)
  • Bispecifics vs CAR-T: Analysts select the big winners — and losers — at #ASH18’s biggest ever datapalooza (Endpoints)
  • FDA In Brief: FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply (FDA)
In Focus: International
  • World Health Organization wants panel to study gene editing (AP) (Reuters)
  • The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area (JAMA)
  • ‘CRISPR babies’ lab asked U.S. scientist for help to disable cholesterol gene in human embryos (STAT)
  • Chinese scientist who claimed gene-editing success now missing: report (The Hill) (South China Morning Post)
  • Despite innovation, Europeans wait years for new cancer drugs (Reuters) (Financial Times) (ICR)
  • The Great Pharma Brexit? An Endpoints News snap poll finds most life sciences insiders predicting a debacle for the industry (Endpoints)
  • ASH18: Legend's CAR-T brought back to reality (BioPharmaDive) (Evaluate)
  • J&J to Build Blood-Cancer Push With Controversial China Biotech (Bloomberg)
  • GSK wraps up promised Horlicks sell-off in £3.1B deal with Unilever (Fierce)
  • Evotec and LEO Pharma form drug discovery alliance targeting dermatological conditions (Press)
  • Boehringer inks pact with Domain for GPCR neurology drugs (Fierce)
  • Evidence thin on medical pot, EU illegal drugs body says (Reuters)
  • Trump Says China Will Curtail Fentanyl. The U.S. Has Heard That Before. (NYTimes)
  • Roche says Hemlibra effective in pivotal study (Reuters) (Press)
  • NICE backs Cimzia for psoriasis, but rejects Ilumetri (PharmaTimes)
  • EMA Reduces Trial Requirements For Hemophilia Drugs (Pink Sheet-$)
  • UK and EU inch toward regulatory cooperation after Brexit (BioPharmaDive)
  • UK cancer patients waiting months for accurate diagnosis (PharmaTimes)
  • Chugai's HEMLIBRA Approved in Taiwan for the Treatment of Hemophilia A with Factor VIII Inhibitors (Press)
  • CNMP Approves Gilead’s Descovy and Harvoni (Press 1, 2)
Pharmaceuticals & Biotechnology
  • Novartis's new treatment for hives outperforms Xolair in trials (Reuters) (Endpoints)
  • The Disclosure of Good versus Bad News: Evidence from the Biotech Industry (SSRN)
  • Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement (Hogan Lovells)
  • ASH18: New data can’t lift Bluebird Bio’s depressed shares (Fierce) (Press)
  • Oncobiologics Changes Name to Outlook Therapeutics; Announces Next Steps in Executing ONS-5010 Clinical and Regulatory Strategy (Press)
  • Seattle Genetics CEO goes inside its lightning-quick Adcetris nod, courtesy of FDA's real-time pilot (Fierce)
  • NIH May Give Elevatebio Exclusive CAR T License (BioCentury)
  • #ASH18: Legend Biotech — allied with J&J now — continues to wow the crowd with their BCMA CAR-T update. What will bluebird say? (Endpoints)
  • #ASH18: BeiGene works to bust through the checkpoint crowd with a pivotal readout that proves its PD-1 is better than the rest (Endpoints)
  • #ASH18: Allogene ticks off a high CR rate for updated off-the-shelf CAR-T pioneer. But getting just the right kind of immunosuppression is crucial (Endpoints)
  • Roswell Park spinout raises $35M from Chinese investors to pursue one-two punch for adoptive T cell therapy (Endpoints)
  • FDA Approves Pexion for Treating Noise Aversion in Dogs (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Vanda’s PhII data offer hope for gastroparesis patients who have seen no new treatments in decades (Endpoints)
  • Darzalex (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma (Press)
  • ASH: J&J, AbbVie's Imbruvica steals the CLL spotlight with phase 3 study wins (Fierce)
  • Shield’s Feraccru accepted for review in the US (PharmaTimes)
  • Comprehensive Positive Phase 3 Data for Alexion’s ALXN1210 in Patients with Paroxysmal Nocturnal Hemoglobinuria Presented at American Society of Hematology (ASH) Annual Meeting and Published in Blood (Press)
  • Astellas Presents Updated Results from Phase 1 Study of Gilteritinib Plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) (Press)
  • Updated Data from Phase 1/2 Open-Label Study of BCMA-Directed CAR-T Cell Therapy LCAR-B38M Show Tolerable Safety Profile, High Overall Response and MRD Negative Rate in Treatment of Patients with Advanced R/R Multiple Myeloma1 (Press)
  • Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (Press)
  • New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia (Press)
  • Celgene Corporation Announces Initial Clinical Data from Ongoing Phase 1/2 Evolve Trial with Anti-BCMA CAR T Therapy JCARH125 in Relapsed/Refractory Multiple Myeloma at ASH 2018 (Press)
  • Seattle Genetics and Takeda Present Positive Data from Phase 3 ECHELON-2 Clinical Trial for ADCETRIS (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas (Press)
Medical Devices
  • New Study Illustrates Medtech Industry Response to Digital Innovation and Value-based Care Models (AdvaMed)
  • It's Time For A Better Dialogue Between Regulators And Healthtech Pioneers (Forbes)
  • ResMed buys Propeller Health for $225M to enhance focus on COPD (MedCity)
  • Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold (MassDevice)
  • Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System (MDDI)
  • Micro Interventional Devices touts early results in tricuspid repair trial (Medical Design & Outsourcing)
  • ‘Breakthrough’ eye-pressure sensor trial begins in Germany (MassDevice)
  • FDA OKs expanded JenaValve study (MassDevice)
  • Pivotal trial kicks off for Edwards Lifesciences’ Pascal mitral repair device (MassDevice)
  • Axonics bids for FDA approval of sacral neuromod device (MassDevice) (Press)
US: Assorted & Government
  • Wisconsin GOP rushes to change laws, lock in health care strategy (Politico)
  • Potential Vendors Cautious On Trump Admin’s Medicare Part B Demo (IHP-$)
  • The Canary in the Coal Mine Isn’t Looking So Good Anymore (Drug & Device Law)
  • CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare Advantage (FDA Law Blog)
  • Trump's drug-prices-in-ads idea gets two more nay votes as federal comment deadline looms (Fierce)
  • Teva hit with $6.3M retaliation verdict in age, anti-American discrimination suit (Fierce)
  • Walmart and Aurobindo sued as litigation mounts over contaminated blood pressure drugs (Fierce)
Upcoming Meetings & Events Europe
  • UK invests £66 million in dedicated vaccines facility (PharmaLetter-$)
  • New UK Health Data Research Alliance to boost medical research (PharmaTimes)
  • Pharmacovigilance inspection metrics, 2009 to present (MHRA)
  • Reclassification of medicinal products from dispensing category D to E: evaluation concluded (Swissmedic)
  • PMDA Updates November 2018 (PMDA)
  • In Brief: Hong Kong Regulators Launch Online IVD Classification Tool (Emergo)
  • Minutes of 23rd AHWP Annual Meeting, Kualar Lumpur, Malaysia, 25 Oct 2018 (AHWP)
  • Sun Pharma says open to evaluating certain business transactions if investors not comfortable with them (Economic Times)
  • Validation rules for regulatory transactions provided to Health Canada in the electronic Common Technical Document (eCTD) format (Health Canada)
  • TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018 (TGA)
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.
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