Regulatory Focus™ > News Articles > Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 Jun

Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017)

Posted 05 June 2017 | By Michael Mezher 

Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017)

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

In Focus: US

In Focus: International

  • Ebola epidemic in Congo 'under control': health minister (Reuters)
  • India Acknowledges Three Cases of Zika Virus (NYTimes)
  • Merck KGaA, F-Star in bispecific biobucks bonanza deal (Fierce) (Reuters) (GEN) (Press)
  • Innate Pharma and Novo Nordisk pen early I-O cancer drug deal (Fierce)
  • Celltrion biosim, eyeing Herceptin's megasales, measures up to the Roche med in phase 3 (Fierce) (Press)
  • ASCO dark horse Nanjing Legend Biotech shines with promising CAR-T data (Fierce) (Reuters) (Endpoints)
  • Regeneron, Sanofi make their case for another PD-1 drug (Endpoints) (Press)
  • Brexit: Advising Companies To Prepare For Only The Worst Case Scenario Is Premature, Says BIA (Pink Sheet-$)
  • Medicines Patent Pool Expands From HIV To Hepatitis C & TB, With 100 Projects On The Go (Pink Sheet-$)
  • Health officials set to release a list of drugs everyone on Earth should be able to access (STAT)
  • Biocad registers first rituximab biosimilar in Bolivia and Honduras (Press)
  • EU approves Opdivo for bladder cancer (PharmaTimes) (Press)
  • New game, new rules: Pathways for better and affordable medicines in Europe (Pharmafile)
  • Abbvie names new General Managers for UK and France (Pharmafile)

ASCO News Roundup

  • Early use of J&J's Zytiga extends prostate cancer survival (Reuters) (Endpoints) (Fierce)
  • Juno Therapeutics Mounts CAR-T Comeback With Strong Lymphoma Study Results (The Street) (Endpoints)
  • Eisai's Lenvima nabs survival edge in liver cancer showdown with Bayer's Nexavar (Fierce)
  • Bristol-Myers Squibb's Opdivo, Yervoy put the brakes on mesothelioma in phase 2 (Fierce) (Press)
  • More from BMS: (Sprycel) (Epacadostat + Opdivo) (Opdivo + Yervoy, colorectal cancer) (Opdivo + Yervoy, advanced melanoma) (Yervoy, resected high-risk melanoma) (Anti-LAG-3 + Opdivo, melanoma)
  •  Merck: (Keytruda + Pemetrexed, nonsquamous metastatic NSCLC) (Keytruda + standard therapy in high risk breast cancer) (Keytruda monotherapy in heavily pre-treated advanced gastric cancer) (Keytruda follow up data for urothelial carcinoma) (Keytruda, MSI-H or MMR solid tumors)
  • Pfizer drug delays lung cancer growth longer than Astra's Iressa: study (Reuters) (EP Vantage)
  • Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer (Press)
  • Bluebird, Celgene CAR-T Keeps Multiple Myeloma Patients Relapse Free (The Street) (Endpoints)
  • Kite to launch mid-stage leukemia trial in fourth quarter 2017 (Reuters) (Endpoints) (Fierce) (Press)
  • Roche's Alecensa bests Pfizer's Xalkori in lung cancer trial (Reuters) (Fierce) (Press)
  • Roche presents new data for TECENTRIQ® (atezolizumab) and updates from across its cancer immunotherapy development programme at ASCO 2017 (Press)
  • Lilly adds to data backing breast cancer candidate abemaciclib (PMLive) (Press)
  • Novartis, IBM Watson Health team up for breast cancer project (Reuters) (MobiHealthNews)
  • Leading With Lung: Lung Cancer, PD-1/PD-L1 Take Over ASCO (BioCentury)
  • Puma Biotechnology Announces Positive PB272 Phase II Data from TBCRC 022 Trial in Patients with HER2-Positive Metastatic Breast Cancer with Brain Metastases (Press)
  • Dendreon Announces New Findings Demonstrating Durable and Robust Killer T-Cell Response with PROVENGE (Press)
  • ArQule Presents Phase 1/2 Clinical Data with ARQ 087 in Intrahepatic Cholangiocarcinoma (Press)
  • NantOmics to Present Clinical Trial Data on the Characterization of Molecular Profiles of Metastatic Triple Negative Breast Cancer with GPS Cancer (Press)
  • Zymeworks Presents Safety and Anti-Tumor Activity Data from the Ongoing Phase 1 Study of ZW25 (Press)
  • Encouraging Phase II survival data for nintedanib in malignant pleural mesothelioma presented at ASCO 2017 (Press)
  • GlycoMimetics Presents Updated Data from Ongoing Phase 1/2 Clinical Trial of GMI-1271 in Patients with Acute Myeloid Leukemia (Press)
  • Deciphera Pharmaceuticals Reports Updated Phase 1 Clinical Study Results with DCC-2618 (Press)

Pharmaceuticals & Biotechnology                                  

  • Many COPD Patients Struggle To Pay For Each Breath (NPR)
  • PhRMA CEO: How To Negotiate Better Deals For Prescription Medicines (Forbes)
  • Childhood cancer survivors have fewer long-term side effects: study (Reuters)
  • Much shorter chemo works for many colon cancer patients, study says (Washington Post)
  • Deciphering the immunology combo avalanche (EP Vantage)
  • Let's Talk About That 'New Hope' Drug For Autism (Forbes)
  • Millions of dollars' worth of research in limbo at NIH (Washington Post)
  • Bristol-Myers Squibb and QIAGEN Sign Agreement for Use of NGS Technology to Develop Gene Expression Profiles for Immuno-Oncology Therapies (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Viamet Data for VT-1161 and VT-1598 to be Presented at The American Society for Microbiology's ASM Microbe 2017 Conference (Press)
  • Seres Therapeutics Announces Completion of Enrollment for SER-287 Phase 1b Study in Patients with Ulcerative Colitis (Press)
  • Aurinia Presents Additional Data from Phase Iib Aura-Lv Study, Demonstrating Stable Renal Function and Blood Pressure without Electrolyte Complications Through 48 Weeks (Press)
  • CEL-SCI Submits FDA Response for Its Phase 3 Head and Neck Cancer Trial (Press)
  • Jaguar Animal Health and Napo Pharmaceuticals Announce Filing of Two Orphan Drug Designation Applications with FDA for Mytesi for Serious Unmet Medical Needs (Press)

Medical Devices

  • Generic Combination Products May Be Permitted Delivery Device Variations (Pink Sheet-$)
  • And the U.S. is already great again from a device perspective (MedCityNews)
  • Patent-Eligible Subject Matter and Healthy Aging Technology (MDDI)
  • Boston Scientific CEO touts its TAVR future (MedCityNews)
  • Claret Medical wins de novo FDA nod for Sentinel TAVR filter (MassDevice)
  • New Data Demonstrates High Performance of HDx Enabled by THERANOVA, Baxter's Novel Hemodialysis Therapy (Baxter)

US: Assorted & Government

Upcoming Meetings & Events

Asia

  • CFDA Issues Groundbreaking Proposals for Medical Device Regulatory Reform (Inside Medical Devices)
  • Kyoto University and Astellas Inaugurate "Alliance Station" with Aim of Realizing Advanced Medical Treatments (Press)

India

  • Bharat Biotech's Chikungunya vaccine enters phase-1 clinical trials (Economic Times)
  • Zydus Cadila gets USFDA nod for anti depressant (Economic Times)
  • Health Ministry invites suggestions from all stakeholders on proposal to replace gelatin capsules with cellulose-based capsules (PharmaBiz)
  • Sun Recruits Ex-Cipla Manufacturing Veteran In Compliance Push (SCRIP-$)
  • Global pharma manufacturers of ATMPs face multiple & complex regulatory hassles (PharmaBiz)
  •  Merck trains 25 FDCA officers on GLP to streamline quality assurance protocols and SOPs in labs (PharmaBiz)

Australia

  • Database of TGA test results released (TGA)
  • TGA presentation: Industry, Sydney, 25 May 2017 (TGA)
  • TGA presentation: AusMedtech, 24 May 2017 (TGA)

General Health & Other Interesting Articles

  • Pregnancy after breast cancer doesn't raise recurrence risk-study (Reuters)
  • Rigor Mortis by Richard Harris — sloppy science (Financial Times)

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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