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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)