Recon: Alexion Drug Succeeds in Late-Stage Study; FDA Hold on Gene Therapy Trial

Posted 15 March 2018 | By Ana Mulero 

Recon: Alexion Drug Succeeds in Late-Stage Study; FDA Hold on Gene Therapy Trial

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • Hospitals are confronting a new opioid crisis: an alarming shortage of pain meds (STAT)
  • Cambridge biotech startup to pay $150m to license rare disease drug (The Boston Globe) (Endpoints News)
  • Jennifer Doudna: ‘I still remember my first encounter with DNA’ (Financial Times)
  • FDA's promo police put pharma marketing to the test with 6 new research studies (Fierce)
  • Celltrion's manufacturing headache likely to delay Teva migraine drug until 2019: analysts (Fierce)
  • Milwaukee County sues prescription drug-makers and distributors behind the opioid crisis (Milwaukee Journal Sentinel)
  • NY Opioid Litigation Won't Be Stayed; Lawyers Seeking 1,000 More County-Plaintiffs (Forbes)
  • Physicians and Patients Finally Avoiding Horizon's Expensive Low Value Pain Drugs, Duexis And Vimovo (Forbes)
  • The biotech IPO party rocks on with $120M raise for I/O player Arcus Biosciences (Endpoints News)
  • Drug makers are paying fewer and fewer fines for their bad behavior (STAT-$)
  • Stealth biotech Arbor steps out of the shadows, announcing it’s found a new CRISPR enzyme (STAT-$)
  • HHS is urged to investigate a Gilead hepatitis C patent for failing to disclose federal funding (STAT-$)
  • GSK Says It Can’t Find Marketing Contracts In Zofran MDL (Law360-$)
  • A Biotech Meltdown for the Ages (WSJ)
  • Inside a drug pricing contract (Axios)
  • Pediatric Exclusivity (2 of 3): Amgen v. Hargan (Objective Intent)
  • US FDA approves Strides Shasun's HIV drug (BioSpectrum) (The Economic Times
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Eli Lilly gets a date with FDA experts for once-rejected rheumatoid arthritis drug baricitinib (Endpoints News) (FDA)
  • J&J’s blockbuster hopeful erdafitinib gets ‘breakthrough’ moniker (Endpoints News)
  • Incyte study could bring lessons for cancer immunotherapy (BioPharma Dive)
  • Quest, Genomic Vision extend SMA screening R&D program (Fierce)
  • Positive Phase III readout for Baremsis (The Pharma Letter-$)
  • Nordic Tech House to invest in stem cell company NextCell Pharma (The Daily Telescope)
  • VC Firm Flagship Commits $50M To Gene Control Researcher (Law360-$)
  • Researchers call for investigation into rising mortality rates (PharmaTimes) (The Guardian) (HuffPost) (The Independent)
  • Mayo Clinic boosts clinical trials with IBM Watson artificial intelligence (Healthcare IT News)
  • Ingestible Electronic Capsule Measures Gases in the Gut (JAMA)
  • Creative Minds: Programming Cells to Write Their Own Memoirs (NIH)
  • Worldwide Clinical Trials Acquires Continuum Clinical’s Late Stage Research Practice (Press)
  • Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice (FDA)
  • Zymeworks Advances Clinical Candidate Incorporating Technology from Kairos Acquisition (Press)
  • Healthy Nevada Project Announces Pilot Study Insights and Phase Two Enrollment (Press
Medical Devices
  • MIT study reveals the problem with bioresorbable stents (Drug Delivery Business News)
  • Scientists trick the brain into sensing the movement of a prosthetic (STAT)
  • What Do Trump’s E-Health Changes Mean for Medical Research? (Bloomberg)
  • TSO3 wins expanded FDA nod for Sterizone VP4 sterilizer (MassDevice) (Press)
  • Cerapedics wins FDA IDE nod for P-15L bone graft trial (MassDevice) (Press)
  • Philips receives U.S. FDA 510(k) clearance to market ProxiDiagnost N90, its premium digital radiography and nearby fluoroscopy system (Press)
  • UroViu Corporation's Single-Use Cystoscope Receives FDA 510(k) Clearance and Allowance of U.S. Patent (Press)
  • DxNow, Inc. Receives FDA 510(k) Clearance for ZyMōt ICSI and ZyMōt Multi Sperm Separation Devices (Press)
  • If you think you are at high risk for colon cancer, a simple, painless test could let you know (CNBC)
  • Fed. Circ. Backs PTAB In Upholding Uterine Endoscope IP (Law360-$)
  • Tax Court Flubbed Analysis In Medtronic Case, 8th Circ. Told (Law360-$)
  • Philips showcases digital pathology system for clinical use and advanced imaging analytics to transform pathology services at USCAP 2018 (Press)
  • Hackers could kill patients by attacking their pacemakers, warns Royal Academy of Engineering (The Telegraph)
  • Patients face high out-of-pocket fees for imaging (Reuters)
  • Fitbit will start tracking your period in an attempt to add more value to Fitbit (The Verge)
  • Mexico Turns To Digital Health To Improve Healthcare (Forbes)
  • Genetic Testing Co. Probe `Ominous’ for Diagnostics Scrutiny (Bloomberg
US: Assorted & Government
  • Ohio judge blocks legislation preventing abortions in Down syndrome cases (CNN) (The Hill)
  • Looking At The Year Ahead In Cannabis, Technology, Microdosing, Home Brew and Blockchain (Forbes)
  • The SEC Says Elizabeth Holmes' Fraud Was Worse Than Anyone Thought (Forbes)
  • After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off (Fierce)
  • Hepatitis C Drugs Save Lives, but Sick Prisoners Aren’t Getting Them (NYT)
  • Exclusive: Alexander's ACA market stabilization proposal (Axios)
  • The One-Year Anniversary of the Oncology Center of Excellence (FDA Voice)
  • Senators Introduce Bill to Abrogate Tribal Sovereign Immunity (Patent Law Weblog)
  • Oregon Jumps on the Drug Pricing Transparency Bandwagon (FDA Law Blog)
  • Eyes on Senate Bill to Nip Allergan’s Tribal Immunity Tactic (Bloomberg
Upcoming Meetings & Events Europe
  • EMA Explores How To Make Therapeutic Indication Wording More Consistent (The Pink Sheet-$)
  • New guidelines recommend hysteroscopy test for heavy periods (PharmaTimes)
  • Patients on diabetes scheme shed weight of 15 double cheeseburgers (PharmaTimes)
  • PCI to tackle ‘wait and see’ approach with serialization suite in Ireland (In-PharmaTechnologist
Asia
  • Johnson and Johnson creates new design lab in Singapore (CosmeticDesign-Asia)
  • Smoking tied to higher risk of hearing loss (Reuters)
  • Cellvizio Obtains Positive Assessment from the Korean National Evidence-based healthcare Collaborating Agency (NECA) (Press)
  • MOH, GE delivering digital solutions (Saudi Gazette) (Tahawul Tech
India
  • Johnson & Johnson , Mylan propose ways to cut TB drugs prices in India (The Economic Times)
  • Bayer Pharmaceuticals committed to India growth; to push for more R&D (The Economic Times)
  • Unichem Labs under regulator scanner for launching blood pressure medicines without price approval (The Economic Times)
  • Prices of 851 essential drug formulations cut in past 2 year: Government (The Economic Times)
  • India's leadership in cost-efficient generics is unchallenged: Sanjiv Kaul (Business Standard)
  • India Begins Making a List of Essential Diagnostics Whose Prices Could Be Capped (The Wire)
  • Indian medical device start-ups trying to tide over pricing & infrastructure issues to achieve domestic market acceptance: Vishnu Bhat (Pharmabiz
Australia
  • Indigenous Australians far more likely to die from cancer, new data shows (The Australian)
  • Multiple sclerosis drug recall: Zinbryta (daclizumab) (Herald Sun)
  • Tougher Sanctions And Penalties Kick In For Advertising Breaches In Australia (The Pink Sheet-$) 
Canada
  • Pharmacare and the chaotic world of Canadian drug prices (The Conversation)
  • Information Update - Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids (Press)
  • Ipsen Announces Health Canada Approval of DYSPORT THERAPEUTIC (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults (Press
General Health & Other Interesting Articles
  • Breast cancer patients in U.S. territories receive lower quality care (Reuters)
  • Cigna tapping Amazon's Alexa to help define insurance terminology (Hartford Business)
 
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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