Regulatory Focus™ > News Articles > 6 > Recon: In Biotech, $6 Billion Can Vanish Quickly

Recon: In Biotech, $6 Billion Can Vanish Quickly

Posted 05 June 2018 | By Ana Mulero 

Recon: In Biotech, $6 Billion Can Vanish Quickly

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In Focus: US

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In Focus: International Pharmaceuticals & Biotechnology
  • Opinion: Embracing Competition To Empower Biosimilars (Forbes)
  • AstraZeneca CEO on immunotherapy, drug prices (CNBC)
  • Rebel Allergan investors demand C-suite shakeup after 'half-hearted' strategic review (Fierce)
  • More Thoughts on AbbVie’s Rova-T Implosion (Science Magazine)
  • Gilead ups its bet on HIV, hep B, inking $400M partnership with immunotherapy company Hookipa (Endpoints) (Press)
  • Following FDA win, Portola loses CEO William Lis (Endpoints)
  • OxyContin maker seeks dismissal of Alaska lawsuit (The Associated Press)
  • New risk calculator could change the aspirin, statins, and blood pressure medications some people take (STAT)
  • As CAR-T treatments advance, Washington grapples with ideas for how to pay for them (STAT-$)
  • Sanofi is the latest drug maker to say average net prices fell last year (STAT-$)
  • Versartis stock climbs on reverse merger with Aravive (BioPharma Dive)
  • BIO18: Pfizer's Bourla on volume vs. value (BioPharma Dive)
  • Gilead Sciences Announces Leadership Changes in Corporate Development and Strategy (Press)
  • TESARO Announces Collaboration to Evaluate ZEJULA in Combination With Anti-PD-L1 Cancer Immunotherapy and MEK Inhibitor in Platinum-Sensitive Ovarian Cancer (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • New HIV vaccine test shows promise (Axios)
  • Hours after filing $150M IPO, Tricida shares positive PhIII trial results on CKD drug (Endpoints)
  • Biogen’s Alzheimer’s drug, elenbecestat, shows early promise (pharmaphorum) (Press)
  • FDA Grants Breakthrough Therapy Designation to Gene Therapy for Treatment of CALD (RareDR)
  • ASCO: Pfizer’s dacomitinib bests Iressa in NSCLC overall survival showdown (Fierce) (Press)
  • Randomization in Clinical Trials: Permuted Blocks and Stratification (JAMA)
  • FDA Grants Cellectis IND Approval for UCART22 in B-ALL (Press)
  • Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA (Press)
  • Tricida Announces Positive Pivotal Phase 3 Clinical Trial Results for TRC101 in CKD Patients With Metabolic Acidosis (Press)
  • New Two-Year Data Show Treatment with Janssen’s Stelara (Ustekinumab) Reduced Rates of Hospitalisation and Surgery in Patients with Moderate-to-Severe Crohn’s Disease, Compared with Placebo (Press)
  • NewLink Genetics Announces Final Results from Two Phase 2 Studies of Indoximod Presented at ASCO 2018 (Press)
  • Ritter Pharmaceuticals Highlights Key Phase 2b Clinical Trial Data of RP-G28 for Lactose Intolerance at Digestive Disease Week 2018 (Press)
  • Asterias Biotherapeutics Announces Independent Data Monitoring Committee Completes Last Intermediate Review of AST-OPC1 Clinical Trial in Acute Spinal Cord Injury (Press)
  • Protalix BioTherapeutics Announces Additional Positive Results from Final Analysis of the Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis (Press)
Medical Devices
  • This Fungus Could Help Cure Cancer (Bloomberg)
  • Halyard Health inks $65m deal to acquire CoolSystems (MassDevice)
  • Medtronic releases long term guidance (MassDevice) (Press)
  • Genealogy site MyHeritage says 92 million user accounts compromised (STAT)
  • The convergence of the technology and medical device industries is no longer a practical impossibility (MedCity News)
  • EarlySense acquires predictive analytics to help hospitals assess cardiac risk (Healthcare IT News)
  • UPS seeks to disrupt implantable medical device supply chain (Healthcare Dive)
  • Artificial Intelligence Provides New Path for Securing Connected Medical Devices (AAMI)
  • Joint Commission Promotes ‘Documentation’ as Solution to Common Survey Concerns (AAMI)
  • Enabling Deep-Tissue Networking for Miniature Medical Devices (MIT)
  • Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices (JAMA)
  • Philips receives U.S. FDA 510(k) clearance for its Ingenia Elition MR solution (Press)
  • FDA Clears Biograph Vision PET/CT System From Siemens Healthineers (Press)
  • FDA Approves Smilekey, a Much Anticipated Smileloc Induction Remover Device by Rodo Medical, Inc. (Press)
  • Apollo Endosurgery Announces FDA Approval of Revised Labeling for the ORBERA Intragastric Balloon System (Press)
  • Diamond Orthopedic Announces 510(k) Clearance for Sterile Faceted Screw Technology (Press)
  • Cook Medical, Taewoong Medical Partner to Distribute Stents in the U.S. (Press)
  • CLS and Exact Imaging Sign a Memorandum of Understanding (MoU) to Enter into a Commercial Collaboration on Image Guided Focused Laser Ablation of Disease in Prostate (Press)
  • iSchemaView Completes MDSAP Audit — Moves to Expand Worldwide Adoption of RAPID Imaging Platform (Press)
  • CoreLink Announces the Acquisition of Medical Device Company Expanding Orthopedics (Press)
  • Caladrius Biosciences Sells Rights to Counter-Flow Centrifugation System to Hitachi Chemical Advanced Therapeutics Solutions (Press)
  • Emboline, Inc. Completes Initial Human Clinical Cases With The Emboliner Embolic Protection Catheter (Press)
  • ENDOCUFF Use Is Shown To Reduce Lifetime Direct Medical Costs and Improve Health Outcomes of Interval Colorectal Cancer Screening (Press)
  • CENTOGENE to Open First U.S. Laboratory in Cambridge, MA Focused on Rare Genetic Diseases Diagnostics (Press)
  • Qt Partners with Emergo to Accelerate Time-to-Market for Medical Devices (Press)
  • Healthcare Providers Cite Struggles with Medical Device Security, Data Management -- Unisys Survey (Press)
US: Assorted & Government
  • Kratom advocates fight FDA crackdown (Washington Examiner)
  • Affordable Care Act premiums keep going up (Axios)
  • Maine Voted to Expand Medicaid. Judge Orders the State to Get Moving. (NYT)
  • Long waits under VA’s private health program (AP News)
  • Texas plaintiffs personalize uphill legal challenge to overturn Obamacare (Politico)
  • Allergan's tribal licensing deal, opposed by tech giants, gets appeals court scrutiny (Fierce)
  • More information leads to better quality care for patients. Congress can help (The Hill)
  • Opinion: Every state needs a database with all health insurance claims, not just some (STAT)
  • Nurse Practitioners Boost Presence By 43% In Rural America (Forbes)
  • CMS unveils scorecard for Medicaid programs (Modern Healthcare)
  • Mandatory Shared Decision Making by the Centers for Medicare & Medicaid Services for Cardiovascular Procedures and Other Tests (JAMA)
  • Transition to the ICD-10 in the United States: An Emerging Data Chasm (JAMA)
Upcoming Meetings & Events Europe
  • Changes to look out for in Medical Devices Regulations (PMLiVE)
  • Drugs scandal roils Greek politics (Politico)
  • Fourth Humira biosimilar set for EU approval (pharmaphorum)
  • Migraine prevention drug Aimovig poised for EU approval (pharmaphorum)
  • EU filing for Clovis’ Rubraca in ovarian cancer maintenance setting (PharmaTimes)
  • The Improving Access to Psychological Therapies Manual (NHS England)
Asia
  • Singapore’s HSA Implementing Major Medical Device Regulatory Changes (Emergo Group)
  • Sanofi-Aventis Korea releases dyslipidemia therapy (Korea Biomedical Review)
  • Domestic pharma industry driving huge machinery influx at P-MEC China (BioSpectrum)
  • Roche scrambles to boost Herceptin supply in China after insurance OK triggers shortage (Fierce)
  • Celltrion launches CDMO business at BIO International conference (The Pharma Letter-$) (Press)
  • AtriCure inks multi-year Chinese distro deal with Baheal Pharma (MassDevice)
  • Will blockchain transform healthcare in South Korea? (Tech Wire Asia)
  • IONTAS Signs Collaboration Agreement With LG Chem, Ltd. to Identify Therapeutic Oncology Leads (Press)
  • Verastem Oncology and Yakult Honsha Co., Ltd. Sign Exclusive License Agreement for the Development and Commercialization of Duvelisib in Japan (Press)
India
  • Govt Wants Pharma Firms to Hand Over 1% Profits for Emergency 'Medicine Bank' (The Wire)
  • NPPA weighing options to cap trade margins to reduce prices of medical devices (Pharmabiz)
  • Gujarat FDCA approves plant designs of 110 new mfg units under Make In India programme (Pharmabiz)
Australia
  • System to flag 'dodgy' drugs risks failing consumers, experts warn (The Guardian)
  • Biomedical Translation Fund helps keep kidney disease pharma in Australia (AFR)
  • SA Government describes EPAS as a "failure" that is impairing hospital operations (HITNA)
  • Advance notice - update to an eCTD file download for version 3.1 (TGA)
  • Product defect alert - potential for blister strip to contain lower strength tablets (TGA)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • Consultation: Proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard (TGA)
  • Automation of validation of eCTD and NeeS sequences (TGA)
  • Prescription medicines: registration of new generic medicines and biosimilar medicines (TGA)
  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)
  • Prescription medicines: registration of new chemical entities in Australia (TGA)
  • Clinical Innovations acquires Australian distributor JB Medical Supplies (Press)
Canada
  • No Name chicken burgers recalled after salmonella outbreak (Global News)
  • Notice: Health Canada Review of Vitamin D Levels for Non-Prescription Use (Health Canada)
General Health & Other Interesting Articles
  • A Biotech Entrepreneur Aims To Help Us Stay Young While Growing Old (Forbes)
  • Many people with mild brain injuries don't get follow-up care (Reuters)
  • Young men tend not to seek mental health help. Virtual visits are changing that (CNBC)
  • What The First Microscopes Teach Us About Electronic Health Records (Fortune)
  • She Went to Jail for a Drug Relapse. Tough Love or Too Harsh? (NYT)
  • AI is coming to a doctor's office near you, and AMA wants to be ready (Healthcare IT News)
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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